Directly observed therapy for chronic hepatitis C: A randomized clinical trial in the prison setting

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"paginaFinal" => "451" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Pablo Saiz de la Hoya, Joaquín Portilla, Andrés Marco, Julio García-Guerrero, Inmaculada Faraco, José Antón, José de Juan, Edelmira Pozo" "autores" => array:8 [ 0 => array:4 [ "nombre" => "Pablo" "apellidos" => "Saiz de la Hoya" "email" => array:1 [ 0 => "pabloshz@coma.es" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Joaquín" "apellidos" => "Portilla" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "b" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "Andrés" "apellidos" => "Marco" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "c" "identificador" => "aff0015" ] ] ] 3 => array:3 [ "nombre" => "Julio" "apellidos" => "García-Guerrero" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "d" "identificador" => "aff0020" ] ] ] 4 => 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author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Tratamiento directamente observado de la hepatitis C crónica: un ensayo clínico aleatorizado en el ámbito penitenciario" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 2692 "Ancho" => 2493 "Tamanyo" => 190738 ] ] "descripcion" => array:1 [ "en" => "SVR in different subgroups. (a) SVR with regard to treatment compliance and treatment continuance; †p>0.05 (chi-squared test) and ‡p<0.001 (chi-squared test). (b) SVR with regard to risk factors; †p<0.05 (chi-squared test)." ] ] ] "textoCompleto" => "IntroductionThe prevalence of hepatitis C virus (HCV) infection in incarcerated population is 10–20 times higher than in the general population and ranges between 30% and 40%.<a class="elsevierStyleCrossRefs" href="#bib0005">1,2</a> The high-risk behavioral patterns of the prison inmates, especially intravenous drug use (IDU), account for a substantial proportion of the high HCV prevalence observed within this setting.<a class="elsevierStyleCrossRef" href="#bib0010">2</a> In Spain, though the HCV prevalence among prison inmates has declined during recent years,<a class="elsevierStyleCrossRefs" href="#bib0015">3,4</a> it remains markedly higher than in the general population [23–34%].<a class="elsevierStyleCrossRefs" href="#bib0020">4,5</a>Whether the HCV is eradicated spontaneously or persists is determined, among other factors, by the immune response of the host.<a class="elsevierStyleCrossRef" href="#bib0030">6</a> However, chronic hepatitis develops in 75%–85% of the people infected with HCV, of whom 60%–70% develop active liver disease.<a class="elsevierStyleCrossRef" href="#bib0035">7</a> Risk factors that accelerate the complications of chronically infected subjects, such as injected drug use, co-infections and alcohol use, are common among prison inmates. This risk profile explains the high HCV-related mortality reported in correctional facilities.<a class="elsevierStyleCrossRef" href="#bib0040">8</a> Therefore, diagnosis and treatment of chronic hepatitis C are major concerns in prisons which led to the elaboration of a consensus document to help healthcare professionals deal with HCV infection in prisons.<a class="elsevierStyleCrossRef" href="#bib0045">9</a>Therapy adherence improves the treatment efficacy of chronic hepatitis C.<a class="elsevierStyleCrossRef" href="#bib0050">10</a> Therefore, interventions, such as the directly observed therapy (DOT), which can be easily implemented in the prison setting, may increase the sustained virological response (SVR). To the best of our knowledge, the benefit that this intervention may provide in the prison setting has only been studied in a retrospective and non-comparative study.<a class="elsevierStyleCrossRef" href="#bib0055">11</a> Therefore, we performed a randomized clinical trial to determine to what extent DOT could improve the efficacy of the standard treatment for chronic hepatitis C in the prison setting.Patients and methodsThis was a multicenter, randomized, open clinical trial to evaluate the efficacy of a DOT compared with a self-administered therapy in prison inmates who underwent standard treatment for chronic hepatitis C (based on pegylated interferon alpha-2a and ribavirin).Patients and settingThe study took place in the healthcare centers of 25 prisons in Spain, from July 2006 to September 2008. Eligible participants were prison inmates, men or women, aged over 18 years with chronic hepatitis C that were not previously treated. Prior to inclusion in the study, infection with HCV was confirmed by the presence of a positive antibody to HCV and a positive HCV RNA polymerase chain reaction result (HCV RNA >600UI/mL). Liver biopsy was not mandatory and was only performed if performed routinely at the centers. To be eligible, a Child–Pugh score of 5 was required.<a class="elsevierStyleCrossRefs" href="#bib0060">12,13</a> In addition, within the 2 months before randomization, cirrhotic patients had an abdominal ultrasound, CT scan or MRI without evidence of hepatocellular carcinoma as well as a serologic test that showed alpha-fetoprotein (PFA) <100ng/mL. Patients were ineligible if they had undergone any systemic antiviral, antineoplastic or immunomodulator therapy in the 6 months prior to the first dose of the study treatment or any investigational therapy in the 6 weeks prior to the first dose of the study treatment. Patients with the following comorbidities were also excluded: hepatic disease of an etiology other than HCV; positive IgM anti-HAV test; decompensated hepatic disease (Child–Pugh >6); prior transplantation with a current functional graft; high risk of anemia, coronary disease or cerebrovascular disease that, according to investigator criteria, were unlikely to tolerate an acute hemoglobin reduction (down to 4g/dL); history of severe cardiac disease, thyroid disorder or abnormalities in thyroid function tests, unless they could be controlled with conventional treatment; and other severe comorbid conditions, such as chronic respiratory disease, immunological disease, severe retinopathy, severe psychiatric disorders or convulsive disorder. Women were also excluded if they were pregnant or lactating, as was each man whose partner was pregnant. Patients were excluded in case of neutropenia (neutrophil count <1500cells/mm3), thrombocytopenia (platelet count <90,000cells/mm3), anemia (hemoglobin concentration <12g/dL) or serum creatinine level over 1.5 times the upper limit of normal. Finally, those patients with a history of drug use (including alcohol) in the previous year were excluded, except those who were already on methadone maintenance programs.All patients provided written informed consent prior to entering the study. In accordance with local regulations, the study was approved by the ethics committee of the General University Hospital of Alicante (Spain) and the correctional competent authorities. The study was carried out according to the international ethical recommendations of the Declaration of Helsinki and Oviedo Convention, and according to the Guidelines of Good Clinical Practice and current Spanish legislation for clinical trials (Royal Decree 223/2004). Handling, communication and disposal of personal data for all participating individuals were performed according to Organic Law 15/1999, 13 of December, regarding the protection of personal data.A random allocation sequence was generated centrally by the sponsor, using a prefixed randomization list, and communicated to the investigator each time a new patient was enrolled. Randomization was stratified based on the following variables: HCV genotype (1–4/2–3), viral load (high/low), ALT level (normal/abnormally high) and HIV co-infection (yes/no). The investigator was responsible for assigning each patient to the randomly allocated intervention.InterventionAll patients received standard treatment for hepatitis C based on pegylated interferon alpha-2a and ribavirin and were randomly assigned in a 1:1 ratio to either direct observed therapy (DOT group) or self-administered therapy (non-DOT group). In the DOT group, ribavirin was given by the study nurse, whereas in the non-DOT group, the ribavirin was self-administered. In both groups the subcutaneous injections of pegylated interferon alpha-2a were administered by the study nurse.All patients received subcutaneous, once-weekly injections of 180μg of pegylated interferon alpha-2a for either 48 weeks or 24 weeks. Patients were given oral ribavirin at a dose of 1000mg/day (patients weighing 75kg or less) or 1.200mg/day (those weighing more than 75kg) for 24 weeks (patients with genotype 2 or 3) or 48 weeks (patients with genotype 1 or 4). Patients without HIV co-infection and with genotype 2 or 3 received a fixed dose of ribavirin (800mg/day) for 24 weeks. The participants were followed for 24 additional weeks after treatment cessation. Dose modifications of pegylated interferon alpha-2a, as low as 90μg, were allowed if the patient experienced clinically significant adverse events or laboratory abnormalities. A reduction in the dosage of ribavirin to 600mg/day was also allowed to manage the occurrence of anemia.Sample sizeSample size estimation was based on the principal endpoint: SVR proportion (defined as the proportion of patients with an undetectable HCV RNA level 24 weeks after cessation of the antiviral therapy). To identify an increase of 20% in the SVR proportion in the DOT group compared with the non-DOT group, assuming a power of 80% and a two-tailed significance level of 0.05, 97 patients would be needed in each group. Considering a 20% proportion of withdrawals, a total of 244 patients needed to be included.Statistical methodsThe primary analysis population included all patients who received at least one dose of study drug.Patient characteristics were described using the means and standard deviations for quantitative variables and absolute and relative frequencies for categorical variables. The principal endpoint was the SVR proportion. Follow-up losses were not considered failures for the efficacy analysis. To estimate the effect size, the risk difference and risk ratio were calculated. The same analyses were performed with regard to early virological response (EVR) (i.e., undetectable serum HCV RNA at week 12) and virological response at the end of treatment (ETR). Treatment failure was considered when the reduction of serum HCV RNA at week 12 was <2 log or when serum HCV RNA was detected at week 24 (for those patients in treatment for 48 weeks), at the end of treatment or 24 weeks after end of treatment.Subgroup analyses were performed to estimate the SVR with regard to treatment compliance (defined as the number of doses that were actually administered divided by the number of doses that were prescribed) and treatment continuance (defined as the number of days that the treatment was actually administered divided by the number of days that the treatment was prescribed).The chi-squared test was used to determine whether there were differences in the proportion of SVR between patients with different ranges of treatment duration or different ranges of treatment dose. Chi-squared tests were also used to assess differences in the SVR proportion of patients with different risk factors, such as baseline HIV co-infection, genotype and baseline viral load.Safety variables (i.e., adverse events and serious adverse events) were summarized using absolute frequencies and percentages per group and compared between both groups by the chi-squared test. The mean levels of liver enzymes at week 12 and at the end of treatment were compared between both groups by a parametric or non-parametric test. The Kolmogorov–Smirnov test was previously used to assess whether the variables were normally distributed. For those variables that followed a normal distribution, the t-test was used, and for the ones that did not, the Mann–Whitney test was used.All analyses were performed using IBM-SPSS Statistics version 18.0 software. The statistical tests were two-sided and considered significant at p-value <0.05.ResultsBetween July 2006 and April 2007, a total of 257 eligible inmates were identified in the 25 participant prisons. The follow-up ended in September 2008, and the trial was completed in February 2009, as planned. From the initially identified 257 patients, 5 of them were not randomized and 252 were randomized (122 to DOT and 130 to non-DOT) (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). For both groups no drug treatment was initiated in 4 patients, and 9 patients who had been randomly allocated to DOT rejected to follow DOT and followed no-DOT (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). Therefore, a total 109 patients have been analyzed in the DOT group, and 135 in the non-DOT group (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>).<elsevierMultimedia ident="fig0005"></elsevierMultimedia>Overall, the mean age was 35.9 (SD 6.54), 94.3% were men, 72.1% reported IDU, 21.3% were HIV co-infected and 55.3% had genotype 1 or 4. Most of the patients with genotype 1–4 had mild-moderate fibrosis (93.5% with grade F0–F1–F2). Among patients with genotype G2–G3, the proportion of mild-moderate fibrosis was lower (45.5%). Demographic and baseline clinical characteristics of each group are summarized in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>.<elsevierMultimedia ident="tbl0005"></elsevierMultimedia>Overall median duration of treatment was 33.9 weeks (DOT, 33.9 weeks; no-DOT, 33.4 weeks). Twenty-six patients (10.7%) discontinued study treatment before week 12, and 32 (13.1%) discontinued before the end of treatment. The most frequent reasons for treatment discontinuation were loss to follow-up and treatment failure (<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>).<elsevierMultimedia ident="tbl0010"></elsevierMultimedia>The SVR was 63.5%. In the DOT group, SVR was 60.6% (95% CI, 51.17–69.22), and in the non-DOT group, it was 65.9% (95% CI, 57.59–73.38), without a significant difference between the groups (RR=0.918; 95% IC, 0.746–1.125). Similarly, no significant differences were observed in the secondary efficacy outcomes (i.e., EVR and ETR) between both groups (<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>).<elsevierMultimedia ident="tbl0015"></elsevierMultimedia>The mean proportion of administered doses was 97.9% (SD=6.5), without a significant difference between DOT (97.6%; SD=8.1) and non-DOT (98.2; SD=4.9) (p=0.117). The mean treatment continuance proportion was 82.9% (SD=30.5), which was also not significantly different between DOT (81.3%; SD=29.6) and non-DOT (84.2%; SD=31.3) (p=0.091). The SVR proportion was similar between patients with treatment compliance over 90% and those with treatment compliance less than or equal to 90% (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>a). SVR proportion was significantly different between patients with different grades of treatment continuance (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>a). SVR proportions in subgroups of patients with specific risk factors, such as HIV co-infection and viral load, were significantly lower than each complementary subgroup without the risk factor (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>b). However, no significant differences were observed between intravenous drug users vs. non-users (64.8% vs. 62.1%; p=0.702) and methadone users vs. non-users (64.6% vs. 63.0%; p=0.817).<elsevierMultimedia ident="fig0010"></elsevierMultimedia>Adverse events were reported for 93.4% of the patients (89.7% in the non-DOT group vs. 98.2% in the DOT group, p=0.007). Most of the adverse events were mild (82.1%). The most frequent adverse events were anemia (7.1%), thrombocytopenia (5.9%), neutropenia (5.8%) and leucopenia (4.9%). Serious adverse events were reported for 8.2% of the patients (8.1% in the non-DOT group vs. 8.3% in the DOT group, p=0.975). There was no unexpected adverse event that had not been previously described in the summary of the product characteristics. Most of the adverse events (85.2%) were solved before the end of the study follow-up. Sixty-eight percent of the adverse events did not require medical intervention and only 9 patients discontinued treatment due to adverse events (<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>). Levels of ALT and AST decreased over time in both groups, without significant differences between the groups (p>0.05).DiscussionThe proportion of SVR among inmates who underwent standard treatment for HCV infection under direct observation (DOT) was not superior to that achieved by inmates who received the non-DOT standard treatment. Overall, treatment adherence and the SVR proportion were high in both groups.The lack of difference in the SVR proportion between both groups could be explained by the treatment compliance, which was remarkably high in the overall sample and showed no significant difference between the groups. The fact that in the non-DOT group the only drug that was self-administered was ribavirin could have contributed to the high overall treatment compliance. Moreover, patients in the non-DOT group were given the ribavirin tablets on an on-going basis (one or three times per week), instead of all at once. Similar to our findings, a randomized clinical trial published after the initiation of our study, with the same objective but performed in a different setting (i.e., non-incarcerated patients in a maintenance methadone program), reported no differences between the DOT and the non-DOT group.<a class="elsevierStyleCrossRef" href="#bib0070">14</a> Consistent with our observations, the treatment completion proportion in that trial was also high and was similar between both groups.<a class="elsevierStyleCrossRef" href="#bib0070">14</a>Although the principal hypothesis of this study was not confirmed, our results show an overall substantial SVR proportion among prison inmates (64%), which is higher than those previously reported in this setting [21–55%]<a class="elsevierStyleCrossRefs" href="#bib0075">15–19</a> and within the range of the DOT observed for IDU in the outpatient setting [45–98%].<a class="elsevierStyleCrossRefs" href="#bib0100">20–22</a> Because the previous evidence was based on observational studies, the high SVR proportion observed in this study could be explained by the fact that the study was performed under experimental conditions in a restricted sample of patients with a more favorable risk profile. As expected in this setting, the patients were young, mostly men and showed a substantial proportion of IDU (72%), HIV co-infection (21%) and methadone therapy (32%). However, in general terms, the risk profile, which was typical for prison inmates, was somehow favorable compared with previously reported cohorts in this setting. For instance, the frequency of IDU was lower than those previously reported among inmates with HCV infection in Spain (78–89%), whereas the proportion of patients under methadone maintenance was higher in our cohort.<a class="elsevierStyleCrossRefs" href="#bib0020">4,23</a> Similarly, the proportion of HIV co-infection (20%) was lower than the proportion reported in a study performed in 18 Spanish prisons [40%].<a class="elsevierStyleCrossRef" href="#bib0020">4</a> The fact that this was a randomized clinical trial explains why some risk factors were less prevalent when compared with previous observational studies. However, given the fact that infectious diseases and treatments can be closely monitored in the prison setting, it should be feasible to obtain in daily clinical practice results that are close to those obtained under ideal circumstances in clinical trials, as it was in an observational study performed in a correctional facility in Canada [66%]<a class="elsevierStyleCrossRef" href="#bib0120">24</a> and a retrospective non-comparative study of inmates who underwent DOT for HCV infection [58%].<a class="elsevierStyleCrossRef" href="#bib0055">11</a>Interestingly, a substantial SVR proportion was also achieved within high-risk subgroups in our trial. For instance, SVR among HIV-co-infected inmates was more frequent (48%) compared with previous cohorts of HIV-co-infected inmates [37%].<a class="elsevierStyleCrossRef" href="#bib0075">15</a> SVR could have been even higher if weight-based ribavirin dosage had been used. In addition, the SVR proportion achieved among patients with genotypes 1–4 was higher than previously reported in this setting.<a class="elsevierStyleCrossRefs" href="#bib0075">15–17</a> This finding could be partially explained by the high overall treatment adherence and the high proportion of mild-moderate fibrosis particularly observed in this subgroup. However, as expected, the proportion of SVR was higher among patients with genotypes 2–3 (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>b).Given the high SVR proportion observed even in the high-risk subgroups of our cohort, the overall good SVR results obtained in our study are likely to be explained by the remarkably high treatment compliance, which might also explain why we were unable to observe differences between the two interventions (DOT and non-DOT) or between patients with treatment compliance over 90% compared with those under 90%. In fact, one of the main threats of treatment effectiveness within the prison setting is treatment discontinuation due to the inmates’ release or change of institution.<a class="elsevierStyleCrossRefs" href="#bib0075">15,23</a> Consistently, in our study we observed that treatment continuance accounted for a substantial fraction of the overall SVR. Therefore, good coordination between institutions should be encouraged to avoid therapy discontinuations due to administrative reasons. This coordination will improve HCV treatment effectiveness within this setting, which in the long run will be beneficial for the community into which inmates are released.A potential limitation of our analysis could be that we implemented the as-treated principle (i.e., patients were analyzed in the group where they were actually included), instead of following the intention-to-treat principle (i.e., analyzing patients in the group to which they were randomly allocated, regardless the strategy that they finally followed). This may have biased the results in favor of the intervention under study (DOT). However, when the intention-to-treat analysis was undertaken there were no significant differences (p=0.27) between the SVR achieved at the DOT (SVR=58.4%) and no-DOT group [65.8%],<a class="elsevierStyleCrossRef" href="#bib0125">25</a> consistently to which was obtained in the as-treated analysis. Therefore, we consider that because the potential bias introduced by the 9 patients that crossed-over from the DOT to the no-DOT group would have gone in favor of the DOT group and since no difference in the main outcome (SVR) was observed between groups in both analyses (as-treated and intention-to-treat analyses), the as-treated analysis should not be a matter of concern in this particular case.To the best of our knowledge, this is the first randomized clinical trial of prison inmates with HCV infection and the first multicenter clinical study in Spain reporting the SVR proportion achieved with treatment based on ribavirin and pegylated interferon in this setting. Therefore, despite the fact that the principal hypothesis was not confirmed, our results provide evidence on the efficacy of the treatment for HCV infection among prison inmates. The access to healthcare professionals, the weekly administration of ribavirin in the no-DOT group and the administration of the interferon by nurses, may have contributed to increase the efficacy in the no-DOT group.In conclusion, our study failed to demonstrate any additional benefit in terms of efficacy of the direct observed therapy among prison inmates with HCV infection who underwent standard treatment based on pegylated interferon alpha-2a and ribavirin. However, the SVR proportion was remarkably high, possibly due the high proportion of treatment adherence. This latter finding suggests that treatment continuance should be a key target of treatment programs within this setting. The fact that for both strategies the health professionals’ intervention was high (i.e., the medication was distributed by nurses in a weekly basis, providing also advice to prevent adverse events) may have also contributed to the good results obtained and should be considered for treatment programs in other settings.Financial supportThe sponsor of the study, the Spanish Society of Prison Health Working Group on Infectious Diseases (GEISESP), received an unrestricted grant from Roche Farma S.A.Initial data analyses were undertaken by Ignacio Fernández who is employee of Roche Farma S.A.Writing support was provided by Teresa Hernando of COCIENTE S.L. and funded by Roche Farma S.A.Role of the sponsorThe sponsor of the study was the Spanish Society of Prison Health Working Group on Infectious Diseases (GEISESP). GEISEP was involved in the design and conduct of the study, and the preparation, review and approval of the manuscript. The funding organization, Roche Farma S.A., was involved in the conduct of the study, the data management and the analysis of the data, but was not involved in the design of the study and preparation, review and approval of the manuscript.Conflicts of interestDr. Saiz de la Hoya has received fees for lectures and/or consultancy for his participation in advisory boards from Abbott Laboratories, Bristol-Myers Squibb, Boerhinger-Ingelheim, Janssen-Cilag, MSD, Roche, Schering Plough and ViiV; Dr. Portilla has received fees for lectures and/or consultancy for his participation in advisory boards from Abbott Laboratories, Bristol-Myers Squibb, Boerhinger-Ingelheim, Janssen-Cilag, MSD, Gilead, Roche and ViiV; Dr. Marco has received fees for lectures and/or consultancy for his participation in advisory boards from Abbott Laboratories, Bristol-Myers Squibb, Boerhinger-Ingelheim, Janssen-Cilag, MSD, Gilead, Roche and ViiV; Dr. Garcia-Guerrero declares no conflicts of interest; Dr. Faraco has received fees for lectures and/or consultancy for her participation in advisory boards from BMS, Boerhinger y Roche; Dr. Anton has received fees for lectures and/or consultancy for his participation in advisory boards, from Bristol-Myers Squibb, Janssen-Cilag, MSD, and Roche; Dr. De Juan has received fees for lectures and/or consultancy for his participation in advisory boards from Roche Pharma; Dr. Pozo declares no conflicts of interest.Author contributionsAll authors have contributed to and agree on the content of the manuscript. The role of each author was as follows:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005">-Study concept and study design: Saiz de la Hoya P, Portilla J, Marco A, Garcia-Guerrero J, Faraco I, Antón J.</li><li class="elsevierStyleListItem" id="lsti0010">-Data collection: Saiz de la Hoya P, Marco A, Garcia-Guerrero J, Faraco I, Antón J, De Juan J, Pozo E.</li><li class="elsevierStyleListItem" id="lsti0015">-Analysis and interpretation of results: Saiz de la Hoya P, Marco A, Portilla J.</li><li class="elsevierStyleListItem" id="lsti0020">-Preparation of the manuscript drafts: Saiz de la Hoya P, Portilla J, Marco A, Garcia-Guerrero J, Faraco I, Antón J.</li><li class="elsevierStyleListItem" id="lsti0025">-Critical review: all the authors.</li><li class="elsevierStyleListItem" id="lsti0030">-Review and approval of the final version of this manuscript that is being submitted for publication: all the authors.</li></ul>" "textoCompletoSecciones" => array:1 [ "secciones" => array:14 [ 0 => array:2 [ "identificador" => "xres369367" "titulo" => array:6 [ 0 => "Abstract" 1 => "Background" 2 => "Objectives" 3 => "Patients and methods" 4 => "Results" 5 => "Conclusions" ] ] 1 => array:2 [ "identificador" => "xpalclavsec348558" "titulo" => "Keywords" ] 2 => array:2 [ "identificador" => "xres369366" "titulo" => array:6 [ 0 => "Resumen" 1 => "Antecedentes" 2 => "Objetivos" 3 => "Pacientes y métodos" 4 => "Resultados" 5 => "Conclusiones" ] ] 3 => array:2 [ "identificador" => "xpalclavsec348557" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Patients and methods" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Patients and setting" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Intervention" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Sample size" ] 3 => array:2 [ "identificador" => "sec0030" "titulo" => "Statistical methods" ] ] ] 6 => array:2 [ "identificador" => "sec0035" "titulo" => "Results" ] 7 => array:2 [ "identificador" => "sec0040" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0045" "titulo" => "Financial support" ] 9 => array:2 [ "identificador" => "sec0050" "titulo" => "Role of the sponsor" ] 10 => array:2 [ "identificador" => "sec0055" "titulo" => "Conflicts of interest" ] 11 => array:2 [ "identificador" => "sec0060" "titulo" => "Author contributions" ] 12 => array:2 [ "identificador" => "xack92782" "titulo" => "Acknowledgements" ] 13 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2013-10-29" "fechaAceptado" => "2014-03-11" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec348558" "palabras" => array:5 [ 0 => "Chronic hepatitis C" 1 => "Directly observed therapy" 2 => "HCV" 3 => "Pegylated interferon" 4 => "Ribavirin" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec348557" "palabras" => array:5 [ 0 => "Hepatitis C crónica" 1 => "Tratamiento directamente observado" 2 => "HCC" 3 => "Interferón pegilado" 4 => "Ribavirina" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "BackgroundThe diagnosis and treatment of chronic hepatitis C are major concerns in prisons. ObjectivesThe aim of this randomized clinical trial was to determine the extent to which directly observed therapy (DOT) improved the efficacy of the standard treatment for chronic hepatitis C in the prison setting. Patients and methodsA randomized clinical trial was carried out to evaluate the efficacy of a DOT compared with a self-administered therapy in prison inmates who underwent standard treatment for chronic hepatitis C (based on pegylated interferon alpha-2a and ribavirin). ResultsA total of 252 inmates were randomized, of which 244 were analyzed: 109 in the DOT group and 135 in the non-DOT group. The mean age was 35.88 years (SD 6.54), 94.3% were men, 72.1% reported intravenous drug use, 21.3% were HIV co-infected, and 55.3% had genotype 1 or 4. The patients received the study treatment for a median time of 33.9 weeks in the overall sample. Sustained virological response was achieved in 60.6% (95% CI, 51.17–69.22) of the DOT group and in 65.9% (95% CI, 57.59–73.38) of the standard therapy group (risk ratio=0.92; 95% CI, 0.76–1.12). The mean proportion of patients continuing the treatment was 83% (SD=31). Adverse events were reported in 93.4% of the patients, and serious adverse events were reported in 8.2%, with no significant differences between groups. ConclusionsSustained virological response was remarkably high, although there were no differences between groups, probably due to high treatment adherence." ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "AntecedentesEl diagnóstico y tratamiento de la hepatitis C crónica son una preocupación importante en los centros penitenciarios. ObjetivosEl propósito de este ensayo clínico aleatorizado fue determinar hasta qué punto el tratamiento directamente observado (TDO) mejoraba la eficacia del tratamiento estándar para la hepatitis C crónica en el ámbito penitenciario. Pacientes y métodosEnsayo clínico aleatorizado para evaluar la eficacia del TDO comparado con el tratamiento auto-administrado en internos que reciben régimen estándar para la hepatitis C crónica (interferón pegilado alfa-2a y ribavirina). ResultadosSe aleatorizaron un total de 252 sujetos, de los cuales se analizaron 244: 109 el grupo TDO y 135 en el grupo no-TDO. La media de edad fue 35,88 (DE 6,54), 94,3% eran hombres, 72,1% eran usuarios de drogas intravenosas, 21,3% co-infectados con HIV y 55,3% tenían genotipo 1 o 4. En la muestra global, los pacientes recibieron el tratamiento del estudio durante una mediana de tiempo de 33,9 semanas. La respuesta virológica sostenida se alcanzó en un 60,6% (IC 95%, 51,17 a 69,22) de los pacientes del grupo TDO y 65,9% (IC 95%, 57,59 a 73,38) en el grupo no-TDO (Riesgo Relativo=0,92; IC 95%, 0,76 a 1,12). La proporción media de continuidad del tratamiento fue 83% (DE=31). Se comunicaron eventos adversos en un 93,4% de los pacientes, y en un 8.2% de los pacientes se notificaron eventos adversos graves, sin diferencias significativas entre ambos grupos. ConclusionesLa respuesta virológica sostenida fue llamativamente elevada, aunque no hubo diferencias entre grupos, probablemente debido a la elevada adherencia al tratamiento en las dos ramas." ] ] "multimedia" => array:5 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2464 "Ancho" => 3000 "Tamanyo" => 278742 ] ] "descripcion" => array:1 [ "en" => "Patient disposition. (*) 9 patients randomized to the DOT group rejected to follow the DOT intervention and were analyzed in the No-DOT group." ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 2692 "Ancho" => 2493 "Tamanyo" => 190738 ] ] "descripcion" => array:1 [ "en" => "SVR in different subgroups. (a) SVR with regard to treatment compliance and treatment continuance; †p>0.05 (chi-squared test) and ‡p<0.001 (chi-squared test). (b) SVR with regard to risk factors; †p<0.05 (chi-squared test)." ] ] 2 => array:7 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:2 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">DOT (N=109)<a class="elsevierStyleCrossRef" href="#tblfn0005">a</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Non-DOT (N=135)<a class="elsevierStyleCrossRef" href="#tblfn0005">a</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">p-Value \t\t\t\t\t\t\n \t\t\t\t</td></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Age \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">36.07 (±6.66) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">35.72 (±6.46) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.683 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Male \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">104 (95.41%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">126.0 (93.33%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.487 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Weight (kg) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">74.30 (±13.11) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">74.40 (±11.71) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.971 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">BMI (kg/m2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24.77 (±3.67) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">25.17 (±3.44) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.391 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">HIV co-infection \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">23 (21.10%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">29 (21.48%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.942 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Abnormally high ALT<a class="elsevierStyleCrossRef" href="#tblfn0005">a</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">85 (77.98%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">104 (77.04%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.861 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Cirrhosis \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 (0.92%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (1.48%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.691 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Serum HCV-RNA (>850,000IU/mL) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">44 (40.37%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">58 (42.96%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.683 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Genotype \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.690 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">G1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">48 (44.04%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">60 (44.44%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">G2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 (3.67%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (1.48%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">G3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">44 (40.37%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">59 (43.70%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">G4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">13 (11.93%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">14 (10.37%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Fibrosis \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.208 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Grade 0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6 (5.50%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 (0.00%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Grade 1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">16 (14.68%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7 (5.19%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Grade 2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 (2.75%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (1.48%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Grade 3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (1.83%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 (2.22%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Grade 4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (1.83%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 (0.00%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Methadone \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">33 (30.28%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">46 (34.07%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.528 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="4" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">On treatment for</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">AR \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">12 (11.01%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">16 (11.85%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.837 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">SSRI \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">13 (11.93%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">23 (17.04%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.263 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Other antidepressants \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">22 (20.18%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24 (17.78%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.633 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">IDU \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">80 (73.39%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">96 (71.11%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.673 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab556448.png" ] ] ] "notaPie" => array:1 [ 0 => array:3 [ "identificador" => "tblfn0005" "etiqueta" => "a" "nota" => "N (%) for categorical variables; mean (±standard deviation) for continuous variables." ] ] ] "descripcion" => array:1 [ "en" => "Demographic and baseline characteristics." ] ] 3 => array:7 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:2 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Before week 12<a class="elsevierStyleCrossRef" href="#tblfn0010">a</a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Before end of treatment<a class="elsevierStyleCrossRef" href="#tblfn0010">a</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Treatment failure \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 (1.6) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">14 (5.7) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Loss to follow-up \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">9 (3.7) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">11 (4.5) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Patient decision \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7 (2.9) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 (1.6) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Adverse event \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6 (2.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 (1.2) \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab556446.png" ] ] ] "notaPie" => array:1 [ 0 => array:3 [ "identificador" => "tblfn0010" "etiqueta" => "a" "nota" => "N (%) out of 244 patients." ] ] ] "descripcion" => array:1 [ "en" => "Treatment discontinuation." ] ] 4 => array:7 [ "identificador" => "tbl0015" "etiqueta" => "Table 3" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:2 [ "leyenda" => "DOT=direct observed therapy; ETR=end of treatment response; EVR=early virological response; SVR=sustained virological response." "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">DOT (N=109) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">No DOT (N=135) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">p-Value \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Risk ratio (95% CI) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Risk difference (95% CI) \t\t\t\t\t\t\n \t\t\t\t</td></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">SVR \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">66 (60.6%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">89 (65.9%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.386 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.918 (0.746–1.125) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.054 (−0.075 to 0.182) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">EVR \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">75 (68.8%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">106 (78.5%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.085 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.876 (0.747–1.029) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.097 (−0.021 to 0.212) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">ETR \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">78 (71.6%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">104 (77%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.329 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.929 (0.792–1.086) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.055 (−0.062 to −0.171) \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab556447.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Treatment response in each group." ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:25 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Chronic hepatitis C in the state prison system: insights into the problems and possible solutions" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "J.C. Imperial" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1586/egh.10.26" "Revista" => array:6 [ "tituloSerie" => "Expert Rev Gastroenterol Hepatol" "fecha" => "2010" "volumen" => "4" "paginaInicial" => "355" "paginaFinal" => "364" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/20528122" "web" => "Medline" ] ] ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0010" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Correlates of hepatitis C virus seropositivity in prison inmates: a meta-analysis" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "M.F. Vescio" 1 => "B. Longo" 2 => "S. Babudieri" 3 => "G. Starnini" 4 => "S. Carbonara" 5 => "G. Rezza" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1136/jech.2006.051599" "Revista" => array:6 [ "tituloSerie" => "J Epidemiol Community Health" "fecha" => "2008" "volumen" => "62" "paginaInicial" => "305" "paginaFinal" => "313" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/18339822" "web" => "Medline" ] ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0015" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Evolution of the main diagnoses of hospital discharges amongst the prison population in Valencia, 2000–2009" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:5 [ 0 => "I. Abad-Perez" 1 => "E. Carbonell-Franco" 2 => "D. Navarro-Garcia" 3 => "F.J. Roig-Sena" 4 => "A. Salazar" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1590/S1575-06202011000200002" "Revista" => array:6 [ "tituloSerie" => "Rev Esp Sanid Penit" "fecha" => "2011" "volumen" => "13" "paginaInicial" => "38" "paginaFinal" => "43" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/21750853" "web" => "Medline" ] ] ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib0020" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Hepatitis C and B prevalence in Spanish prisons" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "P. Saiz de la Hoya" 1 => "A. Marco" 2 => "J. Garcia-Guerrero" 3 => "A. Rivera" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1007/s10096-011-1166-5" "Revista" => array:6 [ "tituloSerie" => "Eur J Clin Microbiol Infect Dis" "fecha" => "2011" "volumen" => "30" "paginaInicial" => "857" "paginaFinal" => "862" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/21274586" "web" => "Medline" ] ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0025" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Chronic hepatitis C virus infection and associated liver disease among the inmates of a Spanish prison" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "J. Murcia" 1 => "J. Portilla" 2 => "M. Bedia" 3 => "J.M. Palazon" 4 => "J. Sanchez-Paya" 5 => "P. Saiz de la Hoya" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.eimc.2008.07.003" "Revista" => array:6 [ "tituloSerie" => "Enferm Infecc Microbiol Clin" "fecha" => "2009" "volumen" => "27" "paginaInicial" => "206" "paginaFinal" => "212" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/19246126" "web" => "Medline" ] ] ] ] ] ] ] ] 5 => array:3 [ "identificador" => "bib0030" "etiqueta" => "6" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Clinical practice. Chronic hepatitis C infection" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "H.R. Rosen" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1056/NEJMcp1006613" "Revista" => array:6 [ "tituloSerie" => "N Engl J Med" "fecha" => "2011" "volumen" => "364" "paginaInicial" => "2429" "paginaFinal" => "2438" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/21696309" "web" => "Medline" ] ] ] ] ] ] ] ] 6 => array:3 [ "identificador" => "bib0035" "etiqueta" => "7" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Global Alert and Response (GAR): Hepatitis C. World Health Organization [14 February 2012]; Available from: <a id="intr0005" class="elsevierStyleInterRef" href="http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index3.html%23diagnosis">http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index3.html#diagnosis</a>" ] ] ] 7 => array:3 [ "identificador" => "bib0040" "etiqueta" => "8" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "HCV-related mortality among male prison inmates in Texas, 1994–2003" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:6 [ 0 => "A.J. Harzke" 1 => "J.G. Baillargeon" 2 => "M.F. Kelley" 3 => "P.M. Diamond" 4 => "K.J. Goodman" 5 => "D.P. Paar" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.annepidem.2009.03.009" "Revista" => array:6 [ "tituloSerie" => "Ann Epidemiol" "fecha" => "2009" "volumen" => "19" "paginaInicial" => "582" "paginaFinal" => "589" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/19443239" "web" => "Medline" ] ] ] ] ] ] ] ] 8 => array:3 [ "identificador" => "bib0045" "etiqueta" => "9" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Expert recommendations for the diagnosis and treatment of chronic hepatitis C infection in the prison setting" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "P. Saiz de la Hoya-Zamacola" 1 => "A. Marco-Mourino" 2 => "G. Clemente-Ricote" 3 => "J. Portilla-Sogorb" 4 => "V. Boix-Martinez" 5 => "O. Nunez-Martinez" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:6 [ "tituloSerie" => "Gastroenterol Hepatol" "fecha" => "2006" "volumen" => "29" "paginaInicial" => "551" "paginaFinal" => "559" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/17129550" "web" => "Medline" ] ] ] ] ] ] ] ] 9 => array:3 [ "identificador" => "bib0050" "etiqueta" => "10" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Predicting sustained virological responses in chronic hepatitis C patients treated with peginterferon alfa-2a (40 KD)/ribavirin" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "P. Ferenci" 1 => "M.W. Fried" 2 => "M.L. Shiffman" 3 => "C.I. Smith" 4 => "G. Marinos" 5 => "F.L. Goncales Jr." ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.jhep.2005.04.009" "Revista" => array:6 [ "tituloSerie" => "J Hepatol" "fecha" => "2005" "volumen" => "43" "paginaInicial" => "425" "paginaFinal" => "433" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/15990196" "web" => "Medline" ] ] ] ] ] ] ] ] 10 => array:3 [ "identificador" => "bib0055" "etiqueta" => "11" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Treatment of chronic hepatitis C virus in the Virginia department of corrections: can compliance overcome racial differences to response?" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "R.K. Sterling" 1 => "C.M. Hofmann" 2 => "V.A. Luketic" 3 => "A.J. Sanyal" 4 => "M.J. Contos" 5 => "A.S. Mills" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1111/j.1572-0241.2004.30310.x" "Revista" => array:6 [ "tituloSerie" => "Am J Gastroenterol" "fecha" => "2004" "volumen" => "99" "paginaInicial" => "866" "paginaFinal" => "872" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/15128352" "web" => "Medline" ] ] ] ] ] ] ] ] 11 => array:3 [ "identificador" => "bib0060" "etiqueta" => "12" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Transection of the oesophagus for bleeding oesophageal varices" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:5 [ 0 => "R.N. Pugh" 1 => "I.M. Murray-Lyon" 2 => "J.L. Dawson" 3 => "M.C. Pietroni" 4 => "R. Williams" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:6 [ "tituloSerie" => "Br J Surg" "fecha" => "1973" "volumen" => "60" "paginaInicial" => "646" "paginaFinal" => "649" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/4541913" "web" => "Medline" ] ] ] ] ] ] ] ] 12 => array:3 [ "identificador" => "bib0065" "etiqueta" => "13" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "The liver and portal hypertension" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "C. Child" 1 => "J. 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Rossi" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1111/j.1572-0241.2008.02065.x" "Revista" => array:6 [ "tituloSerie" => "Am J Gastroenterol" "fecha" => "2008" "volumen" => "103" "paginaInicial" => "2757" "paginaFinal" => "2765" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/18684176" "web" => "Medline" ] ] ] ] ] ] ] ] 14 => array:3 [ "identificador" => "bib0075" "etiqueta" => "15" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Clinical outcomes of hepatitis C treatment in a prison setting: feasibility and effectiveness for challenging treatment populations" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "D.S. Maru" 1 => "R.D. Bruce" 2 => "S. Basu" 3 => "F.L. 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For the development of this study the collaboration of the digestive diseases, hepatology, internal medicine and infectious diseases’ departments of the Spanish participating prisons’ references hospitals has been essential." "vista" => "all" ] ] ] "idiomaDefecto" => "en" "url" => "/02105705/0000003700000008/v1_201409101014/S0210570514000818/v1_201409101014/en/main.assets" "Apartado" => array:4 [ "identificador" => "15961" "tipo" => "SECCION" "es" => array:2 [ "titulo" => "Originales" "idiomaDefecto" => true ] "idiomaDefecto" => "es" ] "PDF" => "https://static.elsevier.es/multimedia/02105705/0000003700000008/v1_201409101014/S0210570514000818/v1_201409101014/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0210570514000818?idApp=UINPBA00004N"]

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Original article

Directly observed therapy for chronic hepatitis C: A randomized clinical trial in the prison setting

Tratamiento directamente observado de la hepatitis C crónica: un ensayo clínico aleatorizado en el ámbito penitenciario

Pablo Saiz de la Hoyaa,

Corresponding author

pabloshz@coma.es

Corresponding author.

, Joaquín Portillab, Andrés Marcoc, Julio García-Guerrerod, Inmaculada Faracoe, José Antónf, José de Juang, Edelmira Pozoh

a Servicios Médicos Centro Penitenciario Fontcalent, Alicante 1, Spain

b Unidad de Enfermedades Infecciosas y Servicio de Medicina Interna, Hospital General Universitario de Alicante, Universidad Miguel Hernández, Elche, Spain

c Servicios Médicos Centro Penitenciario Barcelona Hombres, Spain

d Servicios Médicos Centro Penitenciario, Castellón 1, Spain

e Servicios Médicos Centro Penitenciario, Sevilla 1, Spain

f Servicios Médicos Centro Penitenciario Albolote, Granada, Spain

g Servicios Médicos Centro Penitenciario Córdoba, Spain

h Servicios Médicos Centro Penitenciario Villabona, Asturias, Spain

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            "entidad" => "Servicios M&#233;dicos Centro Penitenciario Villabona&#44; Asturias&#44; Spain"
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        "titulo" => "Tratamiento directamente observado de la hepatitis C cr&#243;nica&#58; un ensayo cl&#237;nico aleatorizado en el &#225;mbito penitenciario"
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          "en" => "<p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">SVR in different subgroups&#46; &#40;a&#41; SVR with regard to treatment compliance and treatment continuance&#59; <span class="elsevierStyleSup">&#8224;</span><span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>0&#46;05 &#40;chi-squared test&#41; and <span class="elsevierStyleSup">&#8225;</span><span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001 &#40;chi-squared test&#41;&#46; &#40;b&#41; SVR with regard to risk factors&#59; <span class="elsevierStyleSup">&#8224;</span><span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05 &#40;chi-squared test&#41;&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">The prevalence of hepatitis C virus &#40;HCV&#41; infection in incarcerated population is 10&#8211;20 times higher than in the general population and ranges between 30&#37; and 40&#37;&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;2</span></a> The high-risk behavioral patterns of the prison inmates&#44; especially intravenous drug use &#40;IDU&#41;&#44; account for a substantial proportion of the high HCV prevalence observed within this setting&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> In Spain&#44; though the HCV prevalence among prison inmates has declined during recent years&#44;<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3&#44;4</span></a> it remains markedly higher than in the general population &#91;23&#8211;34&#37;&#93;&#46;<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;5</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Whether the HCV is eradicated spontaneously or persists is determined&#44; among other factors&#44; by the immune response of the host&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> However&#44; chronic hepatitis develops in 75&#37;&#8211;85&#37; of the people infected with HCV&#44; of whom 60&#37;&#8211;70&#37; develop active liver disease&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> Risk factors that accelerate the complications of chronically infected subjects&#44; such as injected drug use&#44; co-infections and alcohol use&#44; are common among prison inmates&#46; This risk profile explains the high HCV-related mortality reported in correctional facilities&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> Therefore&#44; diagnosis and treatment of chronic hepatitis C are major concerns in prisons which led to the elaboration of a consensus document to help healthcare professionals deal with HCV infection in prisons&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Therapy adherence improves the treatment efficacy of chronic hepatitis C&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> Therefore&#44; interventions&#44; such as the directly observed therapy &#40;DOT&#41;&#44; which can be easily implemented in the prison setting&#44; may increase the sustained virological response &#40;SVR&#41;&#46; To the best of our knowledge&#44; the benefit that this intervention may provide in the prison setting has only been studied in a retrospective and non-comparative study&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> Therefore&#44; we performed a randomized clinical trial to determine to what extent DOT could improve the efficacy of the standard treatment for chronic hepatitis C in the prison setting&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Patients and methods</span><p id="par0020" class="elsevierStylePara elsevierViewall">This was a multicenter&#44; randomized&#44; open clinical trial to evaluate the efficacy of a DOT compared with a self-administered therapy in prison inmates who underwent standard treatment for chronic hepatitis C &#40;based on pegylated interferon alpha-2a and ribavirin&#41;&#46;</p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Patients and setting</span><p id="par0025" class="elsevierStylePara elsevierViewall">The study took place in the healthcare centers of 25 prisons in Spain&#44; from July 2006 to September 2008&#46; Eligible participants were prison inmates&#44; men or women&#44; aged over 18 years with chronic hepatitis C that were not previously treated&#46; Prior to inclusion in the study&#44; infection with HCV was confirmed by the presence of a positive antibody to HCV and a positive HCV RNA polymerase chain reaction result &#40;HCV RNA &#62;600<span class="elsevierStyleHsp" style=""></span>UI&#47;mL&#41;&#46; Liver biopsy was not mandatory and was only performed if performed routinely at the centers&#46; To be eligible&#44; a Child&#8211;Pugh score of 5 was required&#46;<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">12&#44;13</span></a> In addition&#44; within the 2 months before randomization&#44; cirrhotic patients had an abdominal ultrasound&#44; CT scan or MRI without evidence of hepatocellular carcinoma as well as a serologic test that showed alpha-fetoprotein &#40;PFA&#41; &#60;100<span class="elsevierStyleHsp" style=""></span>ng&#47;mL&#46; Patients were ineligible if they had undergone any systemic antiviral&#44; antineoplastic or immunomodulator therapy in the 6 months prior to the first dose of the study treatment or any investigational therapy in the 6 weeks prior to the first dose of the study treatment&#46; Patients with the following comorbidities were also excluded&#58; hepatic disease of an etiology other than HCV&#59; positive IgM anti-HAV test&#59; decompensated hepatic disease &#40;Child&#8211;Pugh &#62;6&#41;&#59; prior transplantation with a current functional graft&#59; high risk of anemia&#44; coronary disease or cerebrovascular disease that&#44; according to investigator criteria&#44; were unlikely to tolerate an acute hemoglobin reduction &#40;down to 4<span class="elsevierStyleHsp" style=""></span>g&#47;dL&#41;&#59; history of severe cardiac disease&#44; thyroid disorder or abnormalities in thyroid function tests&#44; unless they could be controlled with conventional treatment&#59; and other severe comorbid conditions&#44; such as chronic respiratory disease&#44; immunological disease&#44; severe retinopathy&#44; severe psychiatric disorders or convulsive disorder&#46; Women were also excluded if they were pregnant or lactating&#44; as was each man whose partner was pregnant&#46; Patients were excluded in case of neutropenia &#40;neutrophil count &#60;1500<span class="elsevierStyleHsp" style=""></span>cells&#47;mm<span class="elsevierStyleSup">3</span>&#41;&#44; thrombocytopenia &#40;platelet count &#60;90&#44;000<span class="elsevierStyleHsp" style=""></span>cells&#47;mm<span class="elsevierStyleSup">3</span>&#41;&#44; anemia &#40;hemoglobin concentration &#60;12<span class="elsevierStyleHsp" style=""></span>g&#47;dL&#41; or serum creatinine level over 1&#46;5 times the upper limit of normal&#46; Finally&#44; those patients with a history of drug use &#40;including alcohol&#41; in the previous year were excluded&#44; except those who were already on methadone maintenance programs&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">All patients provided written informed consent prior to entering the study&#46; In accordance with local regulations&#44; the study was approved by the ethics committee of the General University Hospital of Alicante &#40;Spain&#41; and the correctional competent authorities&#46; The study was carried out according to the international ethical recommendations of the Declaration of Helsinki and Oviedo Convention&#44; and according to the Guidelines of Good Clinical Practice and current Spanish legislation for clinical trials &#40;Royal Decree 223&#47;2004&#41;&#46; Handling&#44; communication and disposal of personal data for all participating individuals were performed according to Organic Law 15&#47;1999&#44; 13 of December&#44; regarding the protection of personal data&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">A random allocation sequence was generated centrally by the sponsor&#44; using a prefixed randomization list&#44; and communicated to the investigator each time a new patient was enrolled&#46; Randomization was stratified based on the following variables&#58; HCV genotype &#40;1&#8211;4&#47;2&#8211;3&#41;&#44; viral load &#40;high&#47;low&#41;&#44; ALT level &#40;normal&#47;abnormally high&#41; and HIV co-infection &#40;yes&#47;no&#41;&#46; The investigator was responsible for assigning each patient to the randomly allocated intervention&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Intervention</span><p id="par0040" class="elsevierStylePara elsevierViewall">All patients received standard treatment for hepatitis C based on pegylated interferon alpha-2a and ribavirin and were randomly assigned in a 1&#58;1 ratio to either direct observed therapy &#40;DOT group&#41; or self-administered therapy &#40;non-DOT group&#41;&#46; In the DOT group&#44; ribavirin was given by the study nurse&#44; whereas in the non-DOT group&#44; the ribavirin was self-administered&#46; In both groups the subcutaneous injections of pegylated interferon alpha-2a were administered by the study nurse&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">All patients received subcutaneous&#44; once-weekly injections of 180<span class="elsevierStyleHsp" style=""></span>&#956;g of pegylated interferon alpha-2a for either 48 weeks or 24 weeks&#46; Patients were given oral ribavirin at a dose of 1000<span class="elsevierStyleHsp" style=""></span>mg&#47;day &#40;patients weighing 75<span class="elsevierStyleHsp" style=""></span>kg or less&#41; or 1&#46;200<span class="elsevierStyleHsp" style=""></span>mg&#47;day &#40;those weighing more than 75<span class="elsevierStyleHsp" style=""></span>kg&#41; for 24 weeks &#40;patients with genotype 2 or 3&#41; or 48 weeks &#40;patients with genotype 1 or 4&#41;&#46; Patients without HIV co-infection and with genotype 2 or 3 received a fixed dose of ribavirin &#40;800<span class="elsevierStyleHsp" style=""></span>mg&#47;day&#41; for 24 weeks&#46; The participants were followed for 24 additional weeks after treatment cessation&#46; Dose modifications of pegylated interferon alpha-2a&#44; as low as 90<span class="elsevierStyleHsp" style=""></span>&#956;g&#44; were allowed if the patient experienced clinically significant adverse events or laboratory abnormalities&#46; A reduction in the dosage of ribavirin to 600<span class="elsevierStyleHsp" style=""></span>mg&#47;day was also allowed to manage the occurrence of anemia&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Sample size</span><p id="par0050" class="elsevierStylePara elsevierViewall">Sample size estimation was based on the principal endpoint&#58; SVR proportion &#40;defined as the proportion of patients with an undetectable HCV RNA level 24 weeks after cessation of the antiviral therapy&#41;&#46; To identify an increase of 20&#37; in the SVR proportion in the DOT group compared with the non-DOT group&#44; assuming a power of 80&#37; and a two-tailed significance level of 0&#46;05&#44; 97 patients would be needed in each group&#46; Considering a 20&#37; proportion of withdrawals&#44; a total of 244 patients needed to be included&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Statistical methods</span><p id="par0055" class="elsevierStylePara elsevierViewall">The primary analysis population included all patients who received at least one dose of study drug&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Patient characteristics were described using the means and standard deviations for quantitative variables and absolute and relative frequencies for categorical variables&#46; The principal endpoint was the SVR proportion&#46; Follow-up losses were not considered failures for the efficacy analysis&#46; To estimate the effect size&#44; the risk difference and risk ratio were calculated&#46; The same analyses were performed with regard to early virological response &#40;EVR&#41; &#40;i&#46;e&#46;&#44; undetectable serum HCV RNA at week 12&#41; and virological response at the end of treatment &#40;ETR&#41;&#46; Treatment failure was considered when the reduction of serum HCV RNA at week 12 was &#60;2 log or when serum HCV RNA was detected at week 24 &#40;for those patients in treatment for 48 weeks&#41;&#44; at the end of treatment or 24 weeks after end of treatment&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Subgroup analyses were performed to estimate the SVR with regard to treatment compliance &#40;defined as the number of doses that were actually administered divided by the number of doses that were prescribed&#41; and treatment continuance &#40;defined as the number of days that the treatment was actually administered divided by the number of days that the treatment was prescribed&#41;&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">The chi-squared test was used to determine whether there were differences in the proportion of SVR between patients with different ranges of treatment duration or different ranges of treatment dose&#46; Chi-squared tests were also used to assess differences in the SVR proportion of patients with different risk factors&#44; such as baseline HIV co-infection&#44; genotype and baseline viral load&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">Safety variables &#40;i&#46;e&#46;&#44; adverse events and serious adverse events&#41; were summarized using absolute frequencies and percentages per group and compared between both groups by the chi-squared test&#46; The mean levels of liver enzymes at week 12 and at the end of treatment were compared between both groups by a parametric or non-parametric test&#46; The Kolmogorov&#8211;Smirnov test was previously used to assess whether the variables were normally distributed&#46; For those variables that followed a normal distribution&#44; the <span class="elsevierStyleItalic">t</span>-test was used&#44; and for the ones that did not&#44; the Mann&#8211;Whitney test was used&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">All analyses were performed using IBM-SPSS Statistics version 18&#46;0 software&#46; The statistical tests were two-sided and considered significant at <span class="elsevierStyleItalic">p</span>-value &#60;0&#46;05&#46;</p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Results</span><p id="par0085" class="elsevierStylePara elsevierViewall">Between July 2006 and April 2007&#44; a total of 257 eligible inmates were identified in the 25 participant prisons&#46; The follow-up ended in September 2008&#44; and the trial was completed in February 2009&#44; as planned&#46; From the initially identified 257 patients&#44; 5 of them were not randomized and 252 were randomized &#40;122 to DOT and 130 to non-DOT&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46; For both groups no drug treatment was initiated in 4 patients&#44; and 9 patients who had been randomly allocated to DOT rejected to follow DOT and followed no-DOT &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46; Therefore&#44; a total 109 patients have been analyzed in the DOT group&#44; and 135 in the non-DOT group &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0090" class="elsevierStylePara elsevierViewall">Overall&#44; the mean age was 35&#46;9 &#40;SD 6&#46;54&#41;&#44; 94&#46;3&#37; were men&#44; 72&#46;1&#37; reported IDU&#44; 21&#46;3&#37; were HIV co-infected and 55&#46;3&#37; had genotype 1 or 4&#46; Most of the patients with genotype 1&#8211;4 had mild-moderate fibrosis &#40;93&#46;5&#37; with grade F0&#8211;F1&#8211;F2&#41;&#46; Among patients with genotype G2&#8211;G3&#44; the proportion of mild-moderate fibrosis was lower &#40;45&#46;5&#37;&#41;&#46; Demographic and baseline clinical characteristics of each group are summarized in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0095" class="elsevierStylePara elsevierViewall">Overall median duration of treatment was 33&#46;9 weeks &#40;DOT&#44; 33&#46;9 weeks&#59; no-DOT&#44; 33&#46;4 weeks&#41;&#46; Twenty-six patients &#40;10&#46;7&#37;&#41; discontinued study treatment before week 12&#44; and 32 &#40;13&#46;1&#37;&#41; discontinued before the end of treatment&#46; The most frequent reasons for treatment discontinuation were loss to follow-up and treatment failure &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0100" class="elsevierStylePara elsevierViewall">The SVR was 63&#46;5&#37;&#46; In the DOT group&#44; SVR was 60&#46;6&#37; &#40;95&#37; CI&#44; 51&#46;17&#8211;69&#46;22&#41;&#44; and in the non-DOT group&#44; it was 65&#46;9&#37; &#40;95&#37; CI&#44; 57&#46;59&#8211;73&#46;38&#41;&#44; without a significant difference between the groups &#40;RR<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;918&#59; 95&#37; IC&#44; 0&#46;746&#8211;1&#46;125&#41;&#46; Similarly&#44; no significant differences were observed in the secondary efficacy outcomes &#40;i&#46;e&#46;&#44; EVR and ETR&#41; between both groups &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0105" class="elsevierStylePara elsevierViewall">The mean proportion of administered doses was 97&#46;9&#37; &#40;SD<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>6&#46;5&#41;&#44; without a significant difference between DOT &#40;97&#46;6&#37;&#59; SD<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>8&#46;1&#41; and non-DOT &#40;98&#46;2&#59; SD<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>4&#46;9&#41; &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;117&#41;&#46; The mean treatment continuance proportion was 82&#46;9&#37; &#40;SD<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>30&#46;5&#41;&#44; which was also not significantly different between DOT &#40;81&#46;3&#37;&#59; SD<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>29&#46;6&#41; and non-DOT &#40;84&#46;2&#37;&#59; SD<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>31&#46;3&#41; &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;091&#41;&#46; The SVR proportion was similar between patients with treatment compliance over 90&#37; and those with treatment compliance less than or equal to 90&#37; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>a&#41;&#46; SVR proportion was significantly different between patients with different grades of treatment continuance &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>a&#41;&#46; SVR proportions in subgroups of patients with specific risk factors&#44; such as HIV co-infection and viral load&#44; were significantly lower than each complementary subgroup without the risk factor &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>b&#41;&#46; However&#44; no significant differences were observed between intravenous drug users vs&#46; non-users &#40;64&#46;8&#37; vs&#46; 62&#46;1&#37;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;702&#41; and methadone users vs&#46; non-users &#40;64&#46;6&#37; vs&#46; 63&#46;0&#37;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;817&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0110" class="elsevierStylePara elsevierViewall">Adverse events were reported for 93&#46;4&#37; of the patients &#40;89&#46;7&#37; in the non-DOT group vs&#46; 98&#46;2&#37; in the DOT group&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;007&#41;&#46; Most of the adverse events were mild &#40;82&#46;1&#37;&#41;&#46; The most frequent adverse events were anemia &#40;7&#46;1&#37;&#41;&#44; thrombocytopenia &#40;5&#46;9&#37;&#41;&#44; neutropenia &#40;5&#46;8&#37;&#41; and leucopenia &#40;4&#46;9&#37;&#41;&#46; Serious adverse events were reported for 8&#46;2&#37; of the patients &#40;8&#46;1&#37; in the non-DOT group vs&#46; 8&#46;3&#37; in the DOT group&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;975&#41;&#46; There was no unexpected adverse event that had not been previously described in the summary of the product characteristics&#46; Most of the adverse events &#40;85&#46;2&#37;&#41; were solved before the end of the study follow-up&#46; Sixty-eight percent of the adverse events did not require medical intervention and only 9 patients discontinued treatment due to adverse events &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46; Levels of ALT and AST decreased over time in both groups&#44; without significant differences between the groups &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>0&#46;05&#41;&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Discussion</span><p id="par0115" class="elsevierStylePara elsevierViewall">The proportion of SVR among inmates who underwent standard treatment for HCV infection under direct observation &#40;DOT&#41; was not superior to that achieved by inmates who received the non-DOT standard treatment&#46; Overall&#44; treatment adherence and the SVR proportion were high in both groups&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">The lack of difference in the SVR proportion between both groups could be explained by the treatment compliance&#44; which was remarkably high in the overall sample and showed no significant difference between the groups&#46; The fact that in the non-DOT group the only drug that was self-administered was ribavirin could have contributed to the high overall treatment compliance&#46; Moreover&#44; patients in the non-DOT group were given the ribavirin tablets on an on-going basis &#40;one or three times per week&#41;&#44; instead of all at once&#46; Similar to our findings&#44; a randomized clinical trial published after the initiation of our study&#44; with the same objective but performed in a different setting &#40;i&#46;e&#46;&#44; non-incarcerated patients in a maintenance methadone program&#41;&#44; reported no differences between the DOT and the non-DOT group&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> Consistent with our observations&#44; the treatment completion proportion in that trial was also high and was similar between both groups&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a></p><p id="par0125" class="elsevierStylePara elsevierViewall">Although the principal hypothesis of this study was not confirmed&#44; our results show an overall substantial SVR proportion among prison inmates &#40;64&#37;&#41;&#44; which is higher than those previously reported in this setting &#91;21&#8211;55&#37;&#93;<a class="elsevierStyleCrossRefs" href="#bib0075"><span class="elsevierStyleSup">15&#8211;19</span></a> and within the range of the DOT observed for IDU in the outpatient setting &#91;45&#8211;98&#37;&#93;&#46;<a class="elsevierStyleCrossRefs" href="#bib0100"><span class="elsevierStyleSup">20&#8211;22</span></a> Because the previous evidence was based on observational studies&#44; the high SVR proportion observed in this study could be explained by the fact that the study was performed under experimental conditions in a restricted sample of patients with a more favorable risk profile&#46; As expected in this setting&#44; the patients were young&#44; mostly men and showed a substantial proportion of IDU &#40;72&#37;&#41;&#44; HIV co-infection &#40;21&#37;&#41; and methadone therapy &#40;32&#37;&#41;&#46; However&#44; in general terms&#44; the risk profile&#44; which was typical for prison inmates&#44; was somehow favorable compared with previously reported cohorts in this setting&#46; For instance&#44; the frequency of IDU was lower than those previously reported among inmates with HCV infection in Spain &#40;78&#8211;89&#37;&#41;&#44; whereas the proportion of patients under methadone maintenance was higher in our cohort&#46;<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;23</span></a> Similarly&#44; the proportion of HIV co-infection &#40;20&#37;&#41; was lower than the proportion reported in a study performed in 18 Spanish prisons &#91;40&#37;&#93;&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> The fact that this was a randomized clinical trial explains why some risk factors were less prevalent when compared with previous observational studies&#46; However&#44; given the fact that infectious diseases and treatments can be closely monitored in the prison setting&#44; it should be feasible to obtain in daily clinical practice results that are close to those obtained under ideal circumstances in clinical trials&#44; as it was in an observational study performed in a correctional facility in Canada &#91;66&#37;&#93;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">24</span></a> and a retrospective non-comparative study of inmates who underwent DOT for HCV infection &#91;58&#37;&#93;&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a></p><p id="par0130" class="elsevierStylePara elsevierViewall">Interestingly&#44; a substantial SVR proportion was also achieved within high-risk subgroups in our trial&#46; For instance&#44; SVR among HIV-co-infected inmates was more frequent &#40;48&#37;&#41; compared with previous cohorts of HIV-co-infected inmates &#91;37&#37;&#93;&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> SVR could have been even higher if weight-based ribavirin dosage had been used&#46; In addition&#44; the SVR proportion achieved among patients with genotypes 1&#8211;4 was higher than previously reported in this setting&#46;<a class="elsevierStyleCrossRefs" href="#bib0075"><span class="elsevierStyleSup">15&#8211;17</span></a> This finding could be partially explained by the high overall treatment adherence and the high proportion of mild-moderate fibrosis particularly observed in this subgroup&#46; However&#44; as expected&#44; the proportion of SVR was higher among patients with genotypes 2&#8211;3 &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>b&#41;&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">Given the high SVR proportion observed even in the high-risk subgroups of our cohort&#44; the overall good SVR results obtained in our study are likely to be explained by the remarkably high treatment compliance&#44; which might also explain why we were unable to observe differences between the two interventions &#40;DOT and non-DOT&#41; or between patients with treatment compliance over 90&#37; compared with those under 90&#37;&#46; In fact&#44; one of the main threats of treatment effectiveness within the prison setting is treatment discontinuation due to the inmates&#8217; release or change of institution&#46;<a class="elsevierStyleCrossRefs" href="#bib0075"><span class="elsevierStyleSup">15&#44;23</span></a> Consistently&#44; in our study we observed that treatment continuance accounted for a substantial fraction of the overall SVR&#46; Therefore&#44; good coordination between institutions should be encouraged to avoid therapy discontinuations due to administrative reasons&#46; This coordination will improve HCV treatment effectiveness within this setting&#44; which in the long run will be beneficial for the community into which inmates are released&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">A potential limitation of our analysis could be that we implemented the as-treated principle &#40;i&#46;e&#46;&#44; patients were analyzed in the group where they were actually included&#41;&#44; instead of following the intention-to-treat principle &#40;i&#46;e&#46;&#44; analyzing patients in the group to which they were randomly allocated&#44; regardless the strategy that they finally followed&#41;&#46; This may have biased the results in favor of the intervention under study &#40;DOT&#41;&#46; However&#44; when the intention-to-treat analysis was undertaken there were no significant differences &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;27&#41; between the SVR achieved at the DOT &#40;SVR<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>58&#46;4&#37;&#41; and no-DOT group &#91;65&#46;8&#37;&#93;&#44;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">25</span></a> consistently to which was obtained in the as-treated analysis&#46; Therefore&#44; we consider that because the potential bias introduced by the 9 patients that crossed-over from the DOT to the no-DOT group would have gone in favor of the DOT group and since no difference in the main outcome &#40;SVR&#41; was observed between groups in both analyses &#40;as-treated and intention-to-treat analyses&#41;&#44; the as-treated analysis should not be a matter of concern in this particular case&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">To the best of our knowledge&#44; this is the first randomized clinical trial of prison inmates with HCV infection and the first multicenter clinical study in Spain reporting the SVR proportion achieved with treatment based on ribavirin and pegylated interferon in this setting&#46; Therefore&#44; despite the fact that the principal hypothesis was not confirmed&#44; our results provide evidence on the efficacy of the treatment for HCV infection among prison inmates&#46; The access to healthcare professionals&#44; the weekly administration of ribavirin in the no-DOT group and the administration of the interferon by nurses&#44; may have contributed to increase the efficacy in the no-DOT group&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">In conclusion&#44; our study failed to demonstrate any additional benefit in terms of efficacy of the direct observed therapy among prison inmates with HCV infection who underwent standard treatment based on pegylated interferon alpha-2a and ribavirin&#46; However&#44; the SVR proportion was remarkably high&#44; possibly due the high proportion of treatment adherence&#46; This latter finding suggests that treatment continuance should be a key target of treatment programs within this setting&#46; The fact that for both strategies the health professionals&#8217; intervention was high &#40;i&#46;e&#46;&#44; the medication was distributed by nurses in a weekly basis&#44; providing also advice to prevent adverse events&#41; may have also contributed to the good results obtained and should be considered for treatment programs in other settings&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Financial support</span><p id="par0155" class="elsevierStylePara elsevierViewall">The sponsor of the study&#44; the Spanish Society of Prison Health Working Group on Infectious Diseases &#40;GEISESP&#41;&#44; received an unrestricted grant from Roche Farma S&#46;A&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">Initial data analyses were undertaken by Ignacio Fern&#225;ndez who is employee of Roche Farma S&#46;A&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">Writing support was provided by Teresa Hernando of COCIENTE S&#46;L&#46; and funded by Roche Farma S&#46;A&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Role of the sponsor</span><p id="par0170" class="elsevierStylePara elsevierViewall">The sponsor of the study was the <span class="elsevierStyleGrantSponsor" id="gs0005">Spanish Society of Prison Health Working Group on Infectious Diseases &#40;GEISESP&#41;</span>&#46; GEISEP was involved in the design and conduct of the study&#44; and the preparation&#44; review and approval of the manuscript&#46; The funding organization&#44; Roche Farma S&#46;A&#46;&#44; was involved in the conduct of the study&#44; the data management and the analysis of the data&#44; but was not involved in the design of the study and preparation&#44; review and approval of the manuscript&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Conflicts of interest</span><p id="par0175" class="elsevierStylePara elsevierViewall">Dr&#46; Saiz de la Hoya has received fees for lectures and&#47;or consultancy for his participation in advisory boards from Abbott Laboratories&#44; Bristol-Myers Squibb&#44; Boerhinger-Ingelheim&#44; Janssen-Cilag&#44; MSD&#44; Roche&#44; Schering Plough and ViiV&#59; Dr&#46; Portilla has received fees for lectures and&#47;or consultancy for his participation in advisory boards from Abbott Laboratories&#44; Bristol-Myers Squibb&#44; Boerhinger-Ingelheim&#44; Janssen-Cilag&#44; MSD&#44; Gilead&#44; Roche and ViiV&#59; Dr&#46; Marco has received fees for lectures and&#47;or consultancy for his participation in advisory boards from Abbott Laboratories&#44; Bristol-Myers Squibb&#44; Boerhinger-Ingelheim&#44; Janssen-Cilag&#44; MSD&#44; Gilead&#44; Roche and ViiV&#59; Dr&#46; Garcia-Guerrero declares no conflicts of interest&#59; Dr&#46; Faraco has received fees for lectures and&#47;or consultancy for her participation in advisory boards from BMS&#44; Boerhinger y Roche&#59; Dr&#46; Anton has received fees for lectures and&#47;or consultancy for his participation in advisory boards&#44; from Bristol-Myers Squibb&#44; Janssen-Cilag&#44; MSD&#44; and Roche&#59; Dr&#46; De Juan has received fees for lectures and&#47;or consultancy for his participation in advisory boards from Roche Pharma&#59; Dr&#46; Pozo declares no conflicts of interest&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Author contributions</span><p id="par0180" class="elsevierStylePara elsevierViewall">All authors have contributed to and agree on the content of the manuscript&#46; The role of each author was as follows&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">-</span><p id="par0185" class="elsevierStylePara elsevierViewall">Study concept and study design&#58; Saiz de la Hoya P&#44; Portilla J&#44; Marco A&#44; Garcia-Guerrero J&#44; Faraco I&#44; Ant&#243;n J&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">-</span><p id="par0190" class="elsevierStylePara elsevierViewall">Data collection&#58; Saiz de la Hoya P&#44; Marco A&#44; Garcia-Guerrero J&#44; Faraco I&#44; Ant&#243;n J&#44; De Juan J&#44; Pozo E&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">-</span><p id="par0195" class="elsevierStylePara elsevierViewall">Analysis and interpretation of results&#58; Saiz de la Hoya P&#44; Marco A&#44; Portilla J&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">-</span><p id="par0200" class="elsevierStylePara elsevierViewall">Preparation of the manuscript drafts&#58; Saiz de la Hoya P&#44; Portilla J&#44; Marco A&#44; Garcia-Guerrero J&#44; Faraco I&#44; Ant&#243;n J&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">-</span><p id="par0205" class="elsevierStylePara elsevierViewall">Critical review&#58; all the authors&#46;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">-</span><p id="par0210" class="elsevierStylePara elsevierViewall">Review and approval of the final version of this manuscript that is being submitted for publication&#58; all the authors&#46;</p></li></ul></p></span></span>"
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    "fechaRecibido" => "2013-10-29"
    "fechaAceptado" => "2014-03-11"
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          "identificador" => "xpalclavsec348558"
          "palabras" => array:5 [
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            1 => "Directly observed therapy"
            2 => "HCV"
            3 => "Pegylated interferon"
            4 => "Ribavirin"
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            0 => "Hepatitis C cr&#243;nica"
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        "resumen" => "<span class="elsevierStyleSectionTitle" id="sect0010">Background</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The diagnosis and treatment of chronic hepatitis C are major concerns in prisons&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0015">Objectives</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">The aim of this randomized clinical trial was to determine the extent to which directly observed therapy &#40;DOT&#41; improved the efficacy of the standard treatment for chronic hepatitis C in the prison setting&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0020">Patients and methods</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">A randomized clinical trial was carried out to evaluate the efficacy of a DOT compared with a self-administered therapy in prison inmates who underwent standard treatment for chronic hepatitis C &#40;based on pegylated interferon alpha-2a and ribavirin&#41;&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0025">Results</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">A total of 252 inmates were randomized&#44; of which 244 were analyzed&#58; 109 in the DOT group and 135 in the non-DOT group&#46; The mean age was 35&#46;88 years &#40;SD 6&#46;54&#41;&#44; 94&#46;3&#37; were men&#44; 72&#46;1&#37; reported intravenous drug use&#44; 21&#46;3&#37; were HIV co-infected&#44; and 55&#46;3&#37; had genotype 1 or 4&#46; The patients received the study treatment for a median time of 33&#46;9 weeks in the overall sample&#46; Sustained virological response was achieved in 60&#46;6&#37; &#40;95&#37; CI&#44; 51&#46;17&#8211;69&#46;22&#41; of the DOT group and in 65&#46;9&#37; &#40;95&#37; CI&#44; 57&#46;59&#8211;73&#46;38&#41; of the standard therapy group &#40;risk ratio<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;92&#59; 95&#37; CI&#44; 0&#46;76&#8211;1&#46;12&#41;&#46; The mean proportion of patients continuing the treatment was 83&#37; &#40;SD<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>31&#41;&#46; Adverse events were reported in 93&#46;4&#37; of the patients&#44; and serious adverse events were reported in 8&#46;2&#37;&#44; with no significant differences between groups&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0030">Conclusions</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Sustained virological response was remarkably high&#44; although there were no differences between groups&#44; probably due to high treatment adherence&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle" id="sect0040">Antecedentes</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">El diagn&#243;stico y tratamiento de la hepatitis C cr&#243;nica son una preocupaci&#243;n importante en los centros penitenciarios&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0045">Objetivos</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">El prop&#243;sito de este ensayo cl&#237;nico aleatorizado fue determinar hasta qu&#233; punto el tratamiento directamente observado &#40;TDO&#41; mejoraba la eficacia del tratamiento est&#225;ndar para la hepatitis C cr&#243;nica en el &#225;mbito penitenciario&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0050">Pacientes y m&#233;todos</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Ensayo cl&#237;nico aleatorizado para evaluar la eficacia del TDO comparado con el tratamiento auto-administrado en internos que reciben r&#233;gimen est&#225;ndar para la hepatitis C cr&#243;nica &#40;interfer&#243;n pegilado alfa-2a y ribavirina&#41;&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0055">Resultados</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Se aleatorizaron un total de 252 sujetos&#44; de los cuales se analizaron 244&#58; 109 el grupo TDO y 135 en el grupo no-TDO&#46; La media de edad fue 35&#44;88 &#40;DE 6&#44;54&#41;&#44; 94&#44;3&#37; eran hombres&#44; 72&#44;1&#37; eran usuarios de drogas intravenosas&#44; 21&#44;3&#37; co-infectados con HIV y 55&#44;3&#37; ten&#237;an genotipo 1 o 4&#46; En la muestra global&#44; los pacientes recibieron el tratamiento del estudio durante una mediana de tiempo de 33&#44;9 semanas&#46; La respuesta virol&#243;gica sostenida se alcanz&#243; en un 60&#44;6&#37; &#40;IC 95&#37;&#44; 51&#44;17 a 69&#44;22&#41; de los pacientes del grupo TDO y 65&#44;9&#37; &#40;IC 95&#37;&#44; 57&#44;59 a 73&#44;38&#41; en el grupo no-TDO &#40;Riesgo Relativo<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;92&#59; IC 95&#37;&#44; 0&#44;76 a 1&#44;12&#41;&#46; La proporci&#243;n media de continuidad del tratamiento fue 83&#37; &#40;DE<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>31&#41;&#46; Se comunicaron eventos adversos en un 93&#44;4&#37; de los pacientes&#44; y en un 8&#46;2&#37; de los pacientes se notificaron eventos adversos graves&#44; sin diferencias significativas entre ambos grupos&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0060">Conclusiones</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">La respuesta virol&#243;gica sostenida fue llamativamente elevada&#44; aunque no hubo diferencias entre grupos&#44; probablemente debido a la elevada adherencia al tratamiento en las dos ramas&#46;</p>"
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                  \t\t\t\t">35&#46;72 &#40;&#177;6&#46;46&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Male</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">104 &#40;95&#46;41&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">126&#46;0 &#40;93&#46;33&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#46;487&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Weight &#40;kg&#41;</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">74&#46;30 &#40;&#177;13&#46;11&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">74&#46;40 &#40;&#177;11&#46;71&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">BMI &#40;kg&#47;m</span><span class="elsevierStyleSup"><span class="elsevierStyleItalic">2</span></span><span class="elsevierStyleItalic">&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">24&#46;77 &#40;&#177;3&#46;67&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">25&#46;17 &#40;&#177;3&#46;44&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#46;391&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">HIV co-infection</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">23 &#40;21&#46;10&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">29 &#40;21&#46;48&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">0&#46;942&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Abnormally high ALT</span><a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">85 &#40;77&#46;98&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">104 &#40;77&#46;04&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">0&#46;861&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Cirrhosis</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">1 &#40;0&#46;92&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">2 &#40;1&#46;48&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">0&#46;691&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Serum HCV-RNA &#40;&#62;850&#44;000</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">IU&#47;mL&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">44 &#40;40&#46;37&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">58 &#40;42&#46;96&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#46;683&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Genotype</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#46;690&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>G1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">48 &#40;44&#46;04&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">60 &#40;44&#46;44&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>G2&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">4 &#40;3&#46;67&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">2 &#40;1&#46;48&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>G3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">44 &#40;40&#46;37&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">59 &#40;43&#46;70&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>G4&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">13 &#40;11&#46;93&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">14 &#40;10&#46;37&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Fibrosis</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="" valign="\n
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                  \t\t\t\t">0&#46;208&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Grade 0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">6 &#40;5&#46;50&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0 &#40;0&#46;00&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Grade 1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">16 &#40;14&#46;68&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">7 &#40;5&#46;19&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Grade 2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">3 &#40;2&#46;75&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">2 &#40;1&#46;48&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Grade 3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">2 &#40;1&#46;83&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3 &#40;2&#46;22&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Grade 4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2 &#40;1&#46;83&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0 &#40;0&#46;00&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Methadone</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">33 &#40;30&#46;28&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">46 &#40;34&#46;07&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;528&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " colspan="4" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">On treatment for</span></td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>AR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">12 &#40;11&#46;01&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">16 &#40;11&#46;85&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;837&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>SSRI&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">13 &#40;11&#46;93&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">23 &#40;17&#46;04&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;263&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Other antidepressants&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">22 &#40;20&#46;18&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">24 &#40;17&#46;78&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;633&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>IDU&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">80 &#40;73&#46;39&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">96 &#40;71&#46;11&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;673&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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                0 => "xTab556448.png"
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            0 => array:3 [
              "identificador" => "tblfn0005"
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              "nota" => "<p class="elsevierStyleNotepara" id="npar0005">N &#40;&#37;&#41; for categorical variables&#59; mean &#40;&#177;standard deviation&#41; for continuous variables&#46;</p>"
            ]
          ]
        ]
        "descripcion" => array:1 [
          "en" => "<p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Demographic and baseline characteristics&#46;</p>"
        ]
      ]
      3 => array:7 [
        "identificador" => "tbl0010"
        "etiqueta" => "Table 2"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "tabla" => array:2 [
          "tablatextoimagen" => array:1 [
            0 => array:2 [
              "tabla" => array:1 [
                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">Before week 12<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">a</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">Before end of treatment<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">a</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Treatment failure&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4 &#40;1&#46;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">14 &#40;5&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Loss to follow-up&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">9 &#40;3&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">11 &#40;4&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Patient decision&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">7 &#40;2&#46;9&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4 &#40;1&#46;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Adverse event&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">6 &#40;2&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3 &#40;1&#46;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
              ]
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                0 => "xTab556446.png"
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            0 => array:3 [
              "identificador" => "tblfn0010"
              "etiqueta" => "a"
              "nota" => "<p class="elsevierStyleNotepara" id="npar0010">N &#40;&#37;&#41; out of 244 patients&#46;</p>"
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          ]
        ]
        "descripcion" => array:1 [
          "en" => "<p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Treatment discontinuation&#46;</p>"
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      4 => array:7 [
        "identificador" => "tbl0015"
        "etiqueta" => "Table 3"
        "tipo" => "MULTIMEDIATABLA"
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        "mostrarDisplay" => false
        "tabla" => array:2 [
          "leyenda" => "<p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">DOT<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>direct observed therapy&#59; ETR<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>end of treatment response&#59; EVR<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>early virological response&#59; SVR<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>sustained virological response&#46;</p>"
          "tablatextoimagen" => array:1 [
            0 => array:2 [
              "tabla" => array:1 [
                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">DOT &#40;<span class="elsevierStyleItalic">N</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>109&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">No DOT &#40;<span class="elsevierStyleItalic">N</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>135&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black"><span class="elsevierStyleItalic">p</span>-Value&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">Risk ratio &#40;95&#37; CI&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">Risk difference &#40;95&#37; CI&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">SVR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">66 &#40;60&#46;6&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">89 &#40;65&#46;9&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;386&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;918 &#40;0&#46;746&#8211;1&#46;125&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;054 &#40;&#8722;0&#46;075 to 0&#46;182&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">EVR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">75 &#40;68&#46;8&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">106 &#40;78&#46;5&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;085&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;876 &#40;0&#46;747&#8211;1&#46;029&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;097 &#40;&#8722;0&#46;021 to 0&#46;212&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
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        0 => array:2 [
          "identificador" => "bibs0005"
          "bibliografiaReferencia" => array:25 [
            0 => array:3 [
              "identificador" => "bib0005"
              "etiqueta" => "1"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Chronic hepatitis C in the state prison system&#58; insights into the problems and possible solutions"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:1 [
                            0 => "J&#46;C&#46; Imperial"
                          ]
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                      ]
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                    0 => array:2 [
                      "doi" => "10.1586/egh.10.26"
                      "Revista" => array:6 [
                        "tituloSerie" => "Expert Rev Gastroenterol Hepatol"
                        "fecha" => "2010"
                        "volumen" => "4"
                        "paginaInicial" => "355"
                        "paginaFinal" => "364"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/20528122"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            1 => array:3 [
              "identificador" => "bib0010"
              "etiqueta" => "2"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Correlates of hepatitis C virus seropositivity in prison inmates&#58; a meta-analysis"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "M&#46;F&#46; Vescio"
                            1 => "B&#46; Longo"
                            2 => "S&#46; Babudieri"
                            3 => "G&#46; Starnini"
                            4 => "S&#46; Carbonara"
                            5 => "G&#46; Rezza"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1136/jech.2006.051599"
                      "Revista" => array:6 [
                        "tituloSerie" => "J Epidemiol Community Health"
                        "fecha" => "2008"
                        "volumen" => "62"
                        "paginaInicial" => "305"
                        "paginaFinal" => "313"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/18339822"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            2 => array:3 [
              "identificador" => "bib0015"
              "etiqueta" => "3"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Evolution of the main diagnoses of hospital discharges amongst the prison population in Valencia&#44; 2000&#8211;2009"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:5 [
                            0 => "I&#46; Abad-Perez"
                            1 => "E&#46; Carbonell-Franco"
                            2 => "D&#46; Navarro-Garcia"
                            3 => "F&#46;J&#46; Roig-Sena"
                            4 => "A&#46; Salazar"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1590/S1575-06202011000200002"
                      "Revista" => array:6 [
                        "tituloSerie" => "Rev Esp Sanid Penit"
                        "fecha" => "2011"
                        "volumen" => "13"
                        "paginaInicial" => "38"
                        "paginaFinal" => "43"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/21750853"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            3 => array:3 [
              "identificador" => "bib0020"
              "etiqueta" => "4"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Hepatitis C and B prevalence in Spanish prisons"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:4 [
                            0 => "P&#46; Saiz de la Hoya"
                            1 => "A&#46; Marco"
                            2 => "J&#46; Garcia-Guerrero"
                            3 => "A&#46; Rivera"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1007/s10096-011-1166-5"
                      "Revista" => array:6 [
                        "tituloSerie" => "Eur J Clin Microbiol Infect Dis"
                        "fecha" => "2011"
                        "volumen" => "30"
                        "paginaInicial" => "857"
                        "paginaFinal" => "862"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/21274586"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            4 => array:3 [
              "identificador" => "bib0025"
              "etiqueta" => "5"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Chronic hepatitis C virus infection and associated liver disease among the inmates of a Spanish prison"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "J&#46; Murcia"
                            1 => "J&#46; Portilla"
                            2 => "M&#46; Bedia"
                            3 => "J&#46;M&#46; Palazon"
                            4 => "J&#46; Sanchez-Paya"
                            5 => "P&#46; Saiz de la Hoya"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1016/j.eimc.2008.07.003"
                      "Revista" => array:6 [
                        "tituloSerie" => "Enferm Infecc Microbiol Clin"
                        "fecha" => "2009"
                        "volumen" => "27"
                        "paginaInicial" => "206"
                        "paginaFinal" => "212"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/19246126"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            5 => array:3 [
              "identificador" => "bib0030"
              "etiqueta" => "6"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Clinical practice&#46; Chronic hepatitis C infection"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:1 [
                            0 => "H&#46;R&#46; Rosen"
                          ]
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                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1056/NEJMcp1006613"
                      "Revista" => array:6 [
                        "tituloSerie" => "N Engl J Med"
                        "fecha" => "2011"
                        "volumen" => "364"
                        "paginaInicial" => "2429"
                        "paginaFinal" => "2438"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/21696309"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            6 => array:3 [
              "identificador" => "bib0035"
              "etiqueta" => "7"
              "referencia" => array:1 [
                0 => array:1 [
                  "referenciaCompleta" => "Global Alert and Response &#40;GAR&#41;&#58; Hepatitis C&#46; World Health Organization &#91;14 February 2012&#93;&#59; Available from&#58; <a id="intr0005" class="elsevierStyleInterRef" href="http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index3.html%23diagnosis">http&#58;&#47;&#47;www&#46;who&#46;int&#47;csr&#47;disease&#47;hepatitis&#47;whocdscsrlyo2003&#47;en&#47;index3&#46;html&#35;diagnosis</a>"
                ]
              ]
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            7 => array:3 [
              "identificador" => "bib0040"
              "etiqueta" => "8"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "HCV-related mortality among male prison inmates in Texas&#44; 1994&#8211;2003"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:6 [
                            0 => "A&#46;J&#46; Harzke"
                            1 => "J&#46;G&#46; Baillargeon"
                            2 => "M&#46;F&#46; Kelley"
                            3 => "P&#46;M&#46; Diamond"
                            4 => "K&#46;J&#46; Goodman"
                            5 => "D&#46;P&#46; Paar"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1016/j.annepidem.2009.03.009"
                      "Revista" => array:6 [
                        "tituloSerie" => "Ann Epidemiol"
                        "fecha" => "2009"
                        "volumen" => "19"
                        "paginaInicial" => "582"
                        "paginaFinal" => "589"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/19443239"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            8 => array:3 [
              "identificador" => "bib0045"
              "etiqueta" => "9"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Expert recommendations for the diagnosis and treatment of chronic hepatitis C infection in the prison setting"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "P&#46; Saiz de la Hoya-Zamacola"
                            1 => "A&#46; Marco-Mourino"
                            2 => "G&#46; Clemente-Ricote"
                            3 => "J&#46; Portilla-Sogorb"
                            4 => "V&#46; Boix-Martinez"
                            5 => "O&#46; Nunez-Martinez"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:6 [
                        "tituloSerie" => "Gastroenterol Hepatol"
                        "fecha" => "2006"
                        "volumen" => "29"
                        "paginaInicial" => "551"
                        "paginaFinal" => "559"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/17129550"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            9 => array:3 [
              "identificador" => "bib0050"
              "etiqueta" => "10"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Predicting sustained virological responses in chronic hepatitis C patients treated with peginterferon alfa-2a &#40;40 KD&#41;&#47;ribavirin"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "P&#46; Ferenci"
                            1 => "M&#46;W&#46; Fried"
                            2 => "M&#46;L&#46; Shiffman"
                            3 => "C&#46;I&#46; Smith"
                            4 => "G&#46; Marinos"
                            5 => "F&#46;L&#46; Goncales Jr&#46;"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1016/j.jhep.2005.04.009"
                      "Revista" => array:6 [
                        "tituloSerie" => "J Hepatol"
                        "fecha" => "2005"
                        "volumen" => "43"
                        "paginaInicial" => "425"
                        "paginaFinal" => "433"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/15990196"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            10 => array:3 [
              "identificador" => "bib0055"
              "etiqueta" => "11"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Treatment of chronic hepatitis C virus in the Virginia department of corrections&#58; can compliance overcome racial differences to response&#63;"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "R&#46;K&#46; Sterling"
                            1 => "C&#46;M&#46; Hofmann"
                            2 => "V&#46;A&#46; Luketic"
                            3 => "A&#46;J&#46; Sanyal"
                            4 => "M&#46;J&#46; Contos"
                            5 => "A&#46;S&#46; Mills"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1111/j.1572-0241.2004.30310.x"
                      "Revista" => array:6 [
                        "tituloSerie" => "Am J Gastroenterol"
                        "fecha" => "2004"
                        "volumen" => "99"
                        "paginaInicial" => "866"
                        "paginaFinal" => "872"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/15128352"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            11 => array:3 [
              "identificador" => "bib0060"
              "etiqueta" => "12"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Transection of the oesophagus for bleeding oesophageal varices"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:5 [
                            0 => "R&#46;N&#46; Pugh"
                            1 => "I&#46;M&#46; Murray-Lyon"
                            2 => "J&#46;L&#46; Dawson"
                            3 => "M&#46;C&#46; Pietroni"
                            4 => "R&#46; Williams"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:6 [
                        "tituloSerie" => "Br J Surg"
                        "fecha" => "1973"
                        "volumen" => "60"
                        "paginaInicial" => "646"
                        "paginaFinal" => "649"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/4541913"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            12 => array:3 [
              "identificador" => "bib0065"
              "etiqueta" => "13"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "The liver and portal hypertension"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:2 [
                            0 => "C&#46; Child"
                            1 => "J&#46; Turcotte"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "LibroEditado" => array:4 [
                        "titulo" => "Surgery and Portal Hypertension"
                        "paginaInicial" => "50"
                        "paginaFinal" => "58"
                        "serieFecha" => "1964"
                      ]
                    ]
                  ]
                ]
              ]
            ]
            13 => array:3 [
              "identificador" => "bib0070"
              "etiqueta" => "14"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Efficacy and safety of peginterferon alfa-2a&#47;ribavirin in methadone maintenance patients&#58; randomized comparison of direct observed therapy and self-administration"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "H&#46;L&#46; Bonkovsky"
                            1 => "A&#46;D&#46; Tice"
                            2 => "R&#46;G&#46; Yapp"
                            3 => "H&#46;C&#46; Bodenheimer Jr&#46;"
                            4 => "A&#46; Monto"
                            5 => "S&#46;J&#46; Rossi"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1111/j.1572-0241.2008.02065.x"
                      "Revista" => array:6 [
                        "tituloSerie" => "Am J Gastroenterol"
                        "fecha" => "2008"
                        "volumen" => "103"
                        "paginaInicial" => "2757"
                        "paginaFinal" => "2765"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/18684176"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            14 => array:3 [
              "identificador" => "bib0075"
              "etiqueta" => "15"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Clinical outcomes of hepatitis C treatment in a prison setting&#58; feasibility and effectiveness for challenging treatment populations"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:4 [
                            0 => "D&#46;S&#46; Maru"
                            1 => "R&#46;D&#46; Bruce"
                            2 => "S&#46; Basu"
                            3 => "F&#46;L&#46; Altice"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1086/591707"
                      "Revista" => array:6 [
                        "tituloSerie" => "Clin Infect Dis"
                        "fecha" => "2008"
                        "volumen" => "47"
                        "paginaInicial" => "952"
                        "paginaFinal" => "961"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/18715156"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            15 => array:3 [
              "identificador" => "bib0080"
              "etiqueta" => "16"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Treatment of chronic hepatitis C in Canadian prison inmates"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "J&#46;D&#46; Farley"
                            1 => "V&#46;K&#46; Wong"
                            2 => "H&#46;V&#46; Chung"
                            3 => "E&#46; Lim"
                            4 => "G&#46; Walters"
                            5 => "T&#46;A&#46; Farley"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:6 [
                        "tituloSerie" => "Can J Gastroenterol"
                        "fecha" => "2005"
                        "volumen" => "19"
                        "paginaInicial" => "153"
                        "paginaFinal" => "156"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/15776135"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
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              "identificador" => "bib0085"
              "etiqueta" => "17"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Treatment outcomes with pegylated interferon and ribavirin for male prisoners with chronic hepatitis C"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:5 [
                            0 => "K&#46;W&#46; Chew"
                            1 => "S&#46;A&#46; Allen"
                            2 => "L&#46;E&#46; Taylor"
                            3 => "J&#46;D&#46; Rich"
                            4 => "E&#46; Feller"
                          ]
                        ]
                      ]
                    ]
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                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1097/MCG.0b013e31818dd94c"
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                        "tituloSerie" => "J Clin Gastroenterol"
                        "fecha" => "2009"
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                        "paginaInicial" => "686"
                        "paginaFinal" => "691"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/19295448"
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                ]
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                    0 => array:2 [
                      "titulo" => "Combined pegylated interferon and ribavirin for the management of chronic hepatitis C in a prison setting"
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                        0 => array:2 [
                          "etal" => false
                          "autores" => array:3 [
                            0 => "S&#46; Sabbatani"
                            1 => "R&#46; Giuliani"
                            2 => "R&#46; Manfredi"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:6 [
                        "tituloSerie" => "Braz J Infect Dis"
                        "fecha" => "2006"
                        "volumen" => "10"
                        "paginaInicial" => "274"
                        "paginaFinal" => "278"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/17293911"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            18 => array:3 [
              "identificador" => "bib0095"
              "etiqueta" => "19"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Establishment of a successful assessment and treatment service for Australian prison inmates with chronic hepatitis C"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:4 [
                            0 => "L&#46; Boonwaat"
                            1 => "P&#46;S&#46; Haber"
                            2 => "M&#46;H&#46; Levy"
                            3 => "A&#46;R&#46; Lloyd"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:6 [
                        "tituloSerie" => "Med J Aust"
                        "fecha" => "2010"
                        "volumen" => "192"
                        "paginaInicial" => "496"
                        "paginaFinal" => "500"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/20438418"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            19 => array:3 [
              "identificador" => "bib0100"
              "etiqueta" => "20"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Directly observed therapy for the treatment of hepatitis C virus infection in current and former injection drug users"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "J&#46; Grebely"
                            1 => "J&#46;D&#46; Raffa"
                            2 => "C&#46; Meagher"
                            3 => "F&#46; Duncan"
                            4 => "K&#46;A&#46; Genoway"
                            5 => "M&#46; Khara"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1111/j.1440-1746.2007.05032.x"
                      "Revista" => array:6 [
                        "tituloSerie" => "J Gastroenterol Hepatol"
                        "fecha" => "2007"
                        "volumen" => "22"
                        "paginaInicial" => "1519"
                        "paginaFinal" => "1525"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/17645460"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            20 => array:3 [
              "identificador" => "bib0105"
              "etiqueta" => "21"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Successful treatment of chronic hepatitis C with pegylated interferon in combination with ribavirin in a methadone maintenance treatment program"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
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                            1 => "K&#46;A&#46; Harris Jr&#46;"
                            2 => "S&#46; Nahvi"
                            3 => "P&#46;J&#46; Zamor"
                            4 => "I&#46;J&#46; Soloway"
                            5 => "P&#46;L&#46; Tenore"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1016/j.jsat.2008.09.009"
                      "Revista" => array:6 [
                        "tituloSerie" => "J Subst Abuse Treat"
                        "fecha" => "2009"
                        "volumen" => "37"
                        "paginaInicial" => "32"
                        "paginaFinal" => "40"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/19038524"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            21 => array:3 [
              "identificador" => "bib0110"
              "etiqueta" => "22"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "High rates of sustained virological response in hepatitis C virus-infected injection drug users receiving directly observed therapy with peginterferon alpha-2a &#40;40KD&#41; &#40;PEGASYS&#41; and once-daily ribavirin"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:2 [
                            0 => "M&#46; Waizmann"
                            1 => "G&#46; Ackermann"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1016/j.jsat.2010.02.002"
                      "Revista" => array:6 [
                        "tituloSerie" => "J Subst Abuse Treat"
                        "fecha" => "2010"
                        "volumen" => "38"
                        "paginaInicial" => "338"
                        "paginaFinal" => "345"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/20362408"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            22 => array:3 [
              "identificador" => "bib0115"
              "etiqueta" => "23"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Predictors of adherence to treatment of chronic hepatitis C in drug-dependent inmate patients in four prisons in Barcelona&#44; Spain"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "A&#46; Marco Mourino"
                            1 => "A&#46; da Silva Moran"
                            2 => "J&#46; Ortiz Seuma"
                            3 => "C&#46; Sole Carbo"
                            4 => "M&#46; Roget Alemany"
                            5 => "C&#46; Sarriera Gracia"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:6 [
                        "tituloSerie" => "Rev Esp Salud Publica"
                        "fecha" => "2010"
                        "volumen" => "84"
                        "paginaInicial" => "423"
                        "paginaFinal" => "431"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/21141269"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
            23 => array:3 [
              "identificador" => "bib0120"
              "etiqueta" => "24"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Feasibility and outcome of HCV treatment in a Canadian federal prison population"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:6 [
                            0 => "J&#46; Farley"
                            1 => "S&#46; Vasdev"
                            2 => "B&#46; Fischer"
                            3 => "E&#46; Haydon"
                            4 => "J&#46; Rehm"
                            5 => "T&#46;A&#46; Farley"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.2105/AJPH.2004.056150"
                      "Revista" => array:6 [
                        "tituloSerie" => "Am J Public Health"
                        "fecha" => "2005"
                        "volumen" => "95"
                        "paginaInicial" => "1737"
                        "paginaFinal" => "1739"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/16131642"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
            ]
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              "etiqueta" => "25"
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                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Comparative study to assess the efficacy of directly observed ribavirin therapy vs&#46; self-administered ribavirin therapy&#44; both with directly observed pegylated interferon alpha-2a&#44; among prison population with chronic hepatitis C &#40;Clinical Trial RIBADOT&#41;"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "P&#46; Saiz de la Hoya"
                            1 => "A&#46; Marco"
                            2 => "J&#46; Garc&#237;a-Guerrero"
                            3 => "I&#46; Faraco"
                            4 => "J&#46; Ant&#243;n"
                            5 => "J&#46; Portilla"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "LibroEditado" => array:5 [
                        "titulo" => "XIV Congreso de la Sociedad Espa&#241;ola de Enfermedades Infecciosas y Microbiologia Clinica &#40;SEIMC&#41;"
                        "paginaInicial" => "143"
                        "paginaFinal" => "144"
                        "conferencia" => "Barcelona&#44; 12&#8211;22 May 2010"
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                  ]
                ]
              ]
            ]
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        "texto" => "<p id="par0215" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">RIBADOT group</span>&#58; D Isach&#44; M Bedia&#44; R Planella&#44; A Da Silva&#44; G Lopez-Palacio&#44; C Sole&#44; A P&#233;rez-Valenzuela&#44; J Qui&#241;onero&#44; C Hoyos&#44; A Mora&#44; M Bueno&#44; R Moreno&#44; E Campos&#44; A Esteban&#44; JJ Lallana&#44; E Mallada&#44; F Sternberg&#44; L G&#170; Campos&#44; N Teixido&#44; F Fern&#225;ndez&#44; and H Gregorio Mara&#241;on&#46; With the collaboration of the Directorate General for Prisons of the Spanish Government and the Serveis Penitenciaris&#44; Rehabilitaci&#243; I Justicia of the Department of Justice of the Generalitat of Catalonia&#46; For the development of this study the collaboration of the digestive diseases&#44; hepatology&#44; internal medicine and infectious diseases&#8217; departments of the Spanish participating prisons&#8217; references hospitals has been essential&#46;</p>"
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Article information

ISSN: 02105705
Original language: English

DOI:10.1016/j.gastrohep.2014.03.004

The statistics are updated each day

Year/Month	Html	Pdf	Total

2024 October	8	3	11
2024 September	10	7	17
2024 August	15	10	25
2024 July	14	14	28
2024 June	15	1	16
2024 May	10	5	15
2024 April	19	10	29
2024 March	16	2	18
2024 February	11	4	15
2024 January	18	2	20
2023 December	14	2	16
2023 November	18	4	22
2023 October	25	4	29
2023 September	17	0	17
2023 August	13	0	13
2023 July	12	3	15
2023 June	22	5	27
2023 May	41	2	43
2023 April	31	8	39
2023 March	29	2	31
2023 February	29	2	31
2023 January	28	19	47
2022 December	23	6	29
2022 November	21	10	31
2022 October	17	14	31
2022 September	23	19	42
2022 August	23	9	32
2022 July	24	14	38
2022 June	19	15	34
2022 May	18	15	33
2022 April	20	7	27
2022 March	21	6	27
2022 February	28	9	37
2022 January	16	13	29
2021 December	34	9	43
2021 November	29	10	39
2021 October	31	12	43
2021 September	26	17	43
2021 August	33	8	41
2021 July	24	12	36
2021 June	19	6	25
2021 May	30	10	40
2021 April	39	23	62
2021 March	12	6	18
2021 February	22	10	32
2021 January	18	11	29
2020 December	15	9	24
2020 November	22	8	30
2020 October	24	4	28
2020 September	22	11	33
2020 August	30	7	37
2020 July	19	8	27
2020 June	20	19	39
2020 May	38	11	49
2020 April	17	4	21
2020 March	18	10	28
2020 February	22	6	28
2020 January	29	9	38
2019 December	28	7	35
2019 November	27	9	36
2019 October	14	6	20
2019 September	36	13	49
2019 August	11	3	14
2019 July	18	15	33
2019 June	34	21	55
2019 May	120	31	151
2019 April	41	12	53
2019 March	17	13	30
2019 February	20	18	38
2019 January	11	7	18
2018 December	8	3	11
2018 November	13	3	16
2018 October	22	6	28
2018 September	14	8	22
2018 August	10	2	12
2018 July	13	8	21
2018 June	10	5	15
2018 May	9	8	17
2018 April	5	2	7
2018 March	7	0	7
2018 February	8	1	9
2018 January	8	2	10
2017 December	12	1	13
2017 November	20	3	23
2017 October	23	2	25
2017 September	19	2	21
2017 August	23	5	28
2017 July	21	6	27
2017 June	20	24	44
2017 May	24	13	37
2017 April	20	24	44
2017 March	20	76	96
2017 February	17	3	20
2017 January	15	2	17
2016 December	36	8	44
2016 November	29	5	34
2016 October	54	12	66
2016 September	1	2	3
2015 July	0	1	1
2015 March	0	1	1
2015 February	1	0	1
2015 January	0	5	5
2014 December	0	1	1
2014 November	0	4	4
2014 October	2	13	15
2014 September	0	7	7

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