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Randomized clinical trial comparing high versus standard dose of ribavirin plus peginterferon alfa-2a in hepatitis C genotype 3 and high viral load. Dargen-3 study
Estudio clínico aleatorio que compara el uso de dosis elevadas de ribavirina frente a dosis estándar junto con peginterferón alfa-2a en la hepatitis C, genotipo 3 y carga viral elevada. Estudio dargen-3
Conrado M. Fernández-Rodríguez
Corresponding author
, Rosa María Morillas, Helena Masnou, José María Navarro, Rafael Bárcena, José Manuel González, Leticia Martín-Martín, Antonio Poyato, Mireia Miquel-Planas, Francisco Jorquera, Teresa Casanovas, Javier Salmerón, José Luis Calleja, Ricard Solà, Sonia Alonso, Ramón Planas, Manuel Romero-Gomez
Hospital Universitario Fundacion Alcorcon, Unit of Gastroenterology and Hepatology, Madrid, Spain
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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">Hepatitis C virus &#40;HCV&#41; genotype 3 is the second most prevalent genotype in Europe and the USA but predominates in some geographical areas such as India and Pakistan<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46; Current therapy with peginterferon and ribavirin &#40;RBV&#41; remains the standard of care for non-G1 patients&#46; In those infected with genotype 2 or 3&#44; SVR rates have been found to reach 70&#8211;90&#37; with 24 weeks of treatment<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#8211;4</span></a>&#46; Although first generation HCV protease inhibitors boceprevir and telaprevir have been licensed&#44; these agents are not active against HCV genotype 3<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;6</span></a>&#46; The ACCELERATE study demonstrated that 49&#37; of patients with G3 and without RVR achieved SVR with peginterferon alfa-2a and 800<span class="elsevierStyleHsp" style=""></span>mg of RBV&#59; most of these patients presented a baseline viral load greater than 400<span class="elsevierStyleHsp" style=""></span>kIU&#47;mL<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a>&#46; Extending the length of treatment to 36 or to 48 weeks in non-RVR patients did not significantly increase the SVR rate<a class="elsevierStyleCrossRefs" href="#bib5005"><span class="elsevierStyleSup">8&#44;9</span></a>&#46; Zeuzem et al<span class="elsevierStyleItalic">&#46;</span> and Hadziyannis et al<span class="elsevierStyleItalic">&#46;</span> reported that 20&#8211;23&#37; of G3 patients with VL &#62;600<span class="elsevierStyleHsp" style=""></span>kIU&#47;ml relapsed after stopping treatment&#44; compared to the 7&#37; relapse rate observed in patients with baseline VL &#60;600<span class="elsevierStyleHsp" style=""></span>kIU&#47;mL<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;10</span></a>&#46; Furthermore&#44; the dose of RBV seems to play a significant role in the rate of relapse and treatment duration<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11&#44;12</span></a>&#46; Furthermore&#44; a dose of ribavirin ranging from 1600 to 3200<span class="elsevierStyleHsp" style=""></span>mg&#47;day plus peginterferon in genotype 1&#44; showed a 90&#37; of SVR in a small pilot study of 10 patients<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a>&#46; Conversely&#44; intensification of treatment with higher induction dose of peginterferon alfa 2 A did not improve SVR rate in a difficult-to-treat population with genotype 1<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a>&#46; Thus&#44; genotype 3 patients with an HVL and non-RVR showed a relatively poor SVR rate&#44; ranging between 49&#37; and 59&#37;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10&#44;15</span></a>&#46; Very recent data on interferon-free regimes with sofosbuvir&#47;ribavirin in HCV genotype 3 patients unable or unwilling to take interferon have shown SVR rates of 68&#37; in patients without cirrhosis and 21&#37; in patients with cirrhosis<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a>&#46; Extending the length of treatment has not improved the SVR rate&#44; but higher doses of ribavirin have yet to be explored&#46; We designed a randomized study to confirm whether a fixed higher dose of ribavirin together with epoetin &#946; could improve the SVR rate compared to standard-of-care in a cohort of patients with chronic hepatitis C genotype 3 and baseline high viral load&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Materials and methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Study design</span><p id="par0010" class="elsevierStylePara elsevierViewall">DARGEN-3 &#40;Spanish acronym for High Dose Ribavirin in Genotype 3&#41; is a registered clinical trial &#40;EudraCT 2008-000328-16&#59; Clin Trials Gov Identifier <a id="intr0015" class="elsevierStyleInterRef" href="https://clinicaltrials.gov/NCT00830609">NCT00830609</a>&#41;&#46; All procedures were approved by the Ethics Committees of the participating hospitals&#44; and were in accordance with the ethical guidelines of the 1975 Declaration of Helsinki&#46; This randomized phase IV multicenter study was conducted in 21 Spanish hospitals&#44; and compared the efficacy of high dose RBV treatment combined with standard doses of peginterferon &#945;-2a&#44; with the current standard treatment of RBV plus peginterferon &#945;-2a in chronic hepatitis patients with genotype 3 HCV and high VL&#46; Consecutive treatment naive patients with HCV infection and genotype 3 were invited to participate&#46; Eligible patients were &#8805;18 years&#44; chronically infected with HCV genotype 3 and had serum HCV-RNA &#8805;600<span class="elsevierStyleHsp" style=""></span>kIU&#47;ml&#46; A negative pregnancy test in the case of women of childbearing potential and use of contraceptive measures during treatment and 6 months after completion was required&#46; Exclusion criteria included previous treatment with immunomodulators or any experimental medicine &#40;&#8804;6 months&#41;&#44; hepatic comorbidities&#44; previous history of psychiatric disorders&#44; autoimmune diseases&#44; chronic pulmonary disorders&#44; severe heart disease or vascular disorders&#44; organ transplant&#44; decompensated liver disease&#44; other disorders increasing the risk of anemia&#44; neutrophils &#60;1500<span class="elsevierStyleHsp" style=""></span>cells&#47;mm<span class="elsevierStyleSup">3</span>&#44; platelets &#60;90&#44;000<span class="elsevierStyleHsp" style=""></span>units&#47;mm<span class="elsevierStyleSup">3</span> or hemoglobin &#60;12<span class="elsevierStyleHsp" style=""></span>g&#47;dl or &#60;13<span class="elsevierStyleHsp" style=""></span>g&#47;dl &#40;women and men&#44; respectively&#41; in screening tests&#46; All patients provided written informed consent&#46; Patient recruitment started in June 2008 and the study ended in November 2010&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The randomization sequence was created using a computer-generated list of random numbers with a 1&#58;1 allocation without stratification&#46; The allocation sequence was concealed from the researcher&#46; Enrolling and assessment for eligibility was performed in each participating center&#44; and assignment to each treatment arm was centralized by an independent entity&#46; Drugs were stored and dispensed at each hospital pharmacy&#46; Peginterferon &#945;-2a &#40;180<span class="elsevierStyleHsp" style=""></span>&#956;g&#47;week&#41; was administered subcutaneously to all patients&#59; subjects in Arm A received oral RBV &#40;800<span class="elsevierStyleHsp" style=""></span>mg&#47;day&#41; for 24 weeks&#46; Patients in Arm B received oral RBV &#40;1600<span class="elsevierStyleHsp" style=""></span>mg&#47;day&#41; and&#44; to prevent anemia&#44; epoetin &#946; &#40;450<span class="elsevierStyleHsp" style=""></span>IU&#47;kg&#47;week&#41;&#44; initially for 4 weeks&#46; The rationale for per-protocol epoetin &#946; administration to patients receiving higher dose of ribavirin was to prevent RBV dose reduction&#44; thus maximizing the likelihood of achieving RVR and SVR&#46; After this 4-week period&#44; a second regimen could be initiated based on HCV RNA results&#58; if patients in arm B showed RVR at week 4&#44; treatment with peginterferon &#945;-2a &#40;180<span class="elsevierStyleHsp" style=""></span>&#956;g&#47;week&#41; combined with RBV &#40;800<span class="elsevierStyleHsp" style=""></span>mg&#47;day&#41; was continued for an additional 20 weeks &#40;Arm B1&#41;&#44; whereas in patients without RVR at week 4&#44; treatment with peginterferon &#945;-2a &#40;180<span class="elsevierStyleHsp" style=""></span>&#956;g&#47;week&#41; was combined with high RBV dose &#40;1600<span class="elsevierStyleHsp" style=""></span>mg&#47;day&#41; and epoetin &#946; &#40;450<span class="elsevierStyleHsp" style=""></span>IU&#47;kg&#47;week&#41;&#44; and continued for a further 20 weeks&#46; Doses could be adjusted in case of intolerance or as assessed by the attending physician&#44; according to protocol criteria&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Clinical and virological evaluation</span><p id="par0020" class="elsevierStylePara elsevierViewall">Control visits were scheduled at 4&#44; 12 and 24 weeks after beginning treatment and a follow-up visit was scheduled 24 weeks after completion&#46; Blood samples were collected at each visit and virologic and hematologic testing was performed in the same hospital where the samples were collected&#46; Serum HCV RNA levels at baseline and at each time point were evaluated by quantitative polymerase-chain-reaction &#40;PCR&#41; assay &#40;COBAS Amplicor&#174; HCV Monitor Test v2&#46;0&#59; Roche Diagnostics&#41;&#46; All the results of serum HCV-RNA quantification at week 4 had to be available within 5 days after blood extraction&#46; HCV genotyping during screening to identify G3 patients was performed with the use of a hybridization technique&#46; Routine hematology&#44; biochemistry and urine tests were performed at each visit&#44; with a complete physical examination and ophthalmoscopy&#46; Histological assessment of eleven &#40;11&#46;34&#37;&#41; patients who underwent liver biopsy before therapy was available&#44; as were elastography &#40;FibroScan&#174;&#44; EchoSens&#44; Paris&#41; results for 31 &#40;32&#37;&#41; patients&#46; Fibrosis grading was carried out according to the METAVIR Score<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a>&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Efficacy and safety assessment</span><p id="par0025" class="elsevierStylePara elsevierViewall">The primary end-point was the SVR rate&#44; defined as an undetectable serum HCV RNA level 24 weeks after completion of treatment&#46; Secondary variables were RVR&#44; defined as an undetectable serum HCV RNA level at week 4 of treatment&#44; and safety variables &#40;blood tests&#44; physical examination&#44; record of adverse events&#41; for high dose RBV treatment in combination with epoetin &#946;&#46; Virologic relapse was defined as a detectable HCV RNA level during follow-up in patients who had had undetectable HCV RNA at the end of treatment&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Statistical analysis</span><p id="par0030" class="elsevierStylePara elsevierViewall">The expected SVR rate for standard-dose therapy &#40;A&#41; was 0&#46;50<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> and 0&#46;75 for the high dose strategy &#40;B&#41;&#46; To detect statistically significant differences with a two-sided 5&#37; significance level and a power of 80&#37;&#44; a sample size of 116 patients was necessary&#46; Given an anticipated dropouts rate of 10&#37;&#44; final sample size was 128&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Quantitative variables were described with measures of central tendency and dispersion &#40;mean and standard deviation&#44; median and interquartile range&#41;&#46; Qualitative variables were described as absolute &#40;n&#41; and relative frequencies &#40;&#37;&#41;&#46; Fisher&#39;s exact test was used to study differences in RVR and SVR between treatments arms&#46; A subgroup analysis by RVR was performed and a Breslow&#8211;Day test of homogeneity was calculated&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">An exploratory univariate analysis was performed to search for factors associated with the SVR rate&#46; Variables reaching significance in univariate analysis&#44; RVR and treatment variables were introduced in a multivariate logistic regression analysis&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">A lineal general model with repeated measures was used to study hemoglobin concentration curves&#58; time &#40;baseline&#44; 4&#44; 12 and 24 weeks after treatment&#41; was included as intra-subject factor and treatment &#40;A&#44; B1&#44; B2&#41; was included as inter-subject factor&#46; Any interaction effect would show significant differences between groups&#46; Post hoc analysis was performed using the Bonferroni adjustment&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Tests were considered bilateral in all cases with a significance level of 0&#46;05&#46; All analyses were performed using the SPSS package version 17&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Intention-to-treat analyses included all randomized participants &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>97&#41;&#59; missing outcomes were considered non-response&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">An independent data and safety monitoring board performed an interim analysis of efficacy when 80&#37; of the expected number of subjects had accrued and completed the follow-up&#59; no correction of the reported <span class="elsevierStyleItalic">p</span>-value for this interim test was performed&#46;</p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Results</span><p id="par0065" class="elsevierStylePara elsevierViewall">At the time of the interim analysis&#44; 101 patients had been recruited&#44; four of whom were excluded as they did not meet all the inclusion criteria&#46; Finally&#44; 97 evaluable patients were included&#44; of whom 42 were allocated to arm A and 55 to arm B&#46; All patients from both arms had similar baseline demographic characteristics &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; Two patients &#40;one in each arm&#41; were further excluded from the ITT analysis for SVR because they received treatment for a longer period than planned &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0070" class="elsevierStylePara elsevierViewall">The trial was discontinued earlier than intended due to the result of the interim analysis which showed no differences between groups&#46; Further recruitment would have resulted in futility&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">RVR was achieved by 69 out of 97 patients &#40;71&#46;1&#37;&#41;&#46; In arm A&#44; the RVR rate was 64&#46;3&#37; and in arm B it was 76&#46;4&#37;&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;259&#46; Arm B patients were re-allocated to arm B1 &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>42&#41; and B2 &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>13&#41; according to the RVR&#46; At the end of treatment &#40;week 24&#41;&#44; 97&#46;7&#37; achieved a virological response&#44; and percentages were similar in all arms&#44; 100&#37; &#40;A&#41;&#44; 95&#37; &#40;B1&#41; and 100&#37; &#40;B2&#41; &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;613&#41;&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">The SVR rate by ITT analysis was 64&#46;3&#37; in arm A and 61&#46;8&#37; in arm B&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;835&#46; In the PP analysis&#44; 85 subjects who completed the protocol with no missing outcomes were included&#44; 35 in arm A and 50 in arm B&#46; The SVR rate was 77&#46;1&#37; in arm A and 68&#37; in arm B&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;464 &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46; There were 22 Asian patients&#46; Although RVR and SVR rates were also explored separately&#44; results were similar in both ethnic groups&#58; 70&#46;5&#37; of the Caucasian patients achieved RVR and 65&#46;3&#37; SVR&#44; while 73&#46;7&#37; of the Asian patients presented RVR and 77&#46;8&#37; SVR &#40;N&#46;S&#46;&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0155" class="elsevierStylePara elsevierViewall">Five patients discontinued treatment prematurely&#46; The reasons were an adverse event in one case and the patient&#39;s decision in three &#40;two participants in arm A and one in B1&#41;&#46; Another non-responding patient discontinued treatment in B2 due to intolerance &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;649&#41;&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">The overall PP SVR rate was 71&#46;8&#37; with no significant differences between treatment arms&#44; with SVR rates 77&#46;1&#37; &#40;A&#41;&#44; 66&#46;7&#37; &#40;B1&#41; and 72&#46;7&#37; &#40;B2&#41; &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;605&#41;&#46; According to the ITT&#44; SVR was 64&#46;3&#37; &#40;A&#41;&#44; 61&#46;9&#37; &#40;B1&#41; and 61&#46;5&#37; &#40;B2&#41; &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;969&#41;&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">A subgroup analyses according to RVR was performed&#46; In patients who failed to achieve RVR&#44; SVR was achieved in 8&#47;13 &#40;61&#46;5&#37;&#41; patients in arm B2&#44; compared to 5&#47;15 &#40;33&#37;&#41; in arm A&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;255&#46; In patients who achieved RVR&#44; SVR was 22&#47;27 &#40;81&#37;&#41; in arm A and 26&#47;42 &#40;62&#37;&#41; in arm B1&#59; &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;11&#41;&#46; A difference in treatment effect was observed&#44; with a Breslow&#8211;Day test of homogeneity of <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;026&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">With univariate analysis&#44; patients who attained SVR were significantly younger than non-responders &#40;40&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#46;7 vs&#46; 44&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;4 years&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;038&#41;&#46; In addition&#44; non-responders had a higher BMI than responders &#40;27&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;4 vs&#46; 25&#46;1<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;2&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;017&#41; and a lower rate of RVR than non-responders &#40;58&#46;3&#37; vs&#46; 78&#46;7&#37;&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;039&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#41;&#46; Unadjusted treatment effect was OR<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>1&#46;11 &#40;0&#46;48&#8211;2&#46;56&#41; while logistic regression analysis showed a treatment effect after adjustment for RVR&#44; age and BMI of OR<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>1&#46;27 &#40;0&#46;46&#8211;3&#46;49&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0020">Table 4</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><elsevierMultimedia ident="tbl0020"></elsevierMultimedia><p id="par0095" class="elsevierStylePara elsevierViewall">Details on the attribution of adverse events to a drug effect&#44; classified by treatment arm and medication&#44; are provided in <a class="elsevierStyleCrossRef" href="#tbl0025">Table 5</a>&#46; A total of 276 adverse events were reported&#44; 87&#46;6&#37; of which were considered treatment-related&#46; Notably&#44; there were only two cases of mild anemia in arm A &#40;4&#46;76&#37;&#41; and two cases in arm B2 &#40;17&#37;&#41;&#46; The rate of serious adverse events was low &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>3&#41;&#44; with two cases of neutropenia and one case of oral aphthae&#46; Among the overall adverse events&#44; fatigue was the most frequently reported side effect &#40;47&#46;6&#37; in arm A&#44; 40&#46;5&#37; in B1 and 38&#46;5&#37; in B2&#41;&#46; <a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a> shows hemoglobin concentrations over time&#46; The time<span class="elsevierStyleHsp" style=""></span>&#215;<span class="elsevierStyleHsp" style=""></span>treatment interaction effect was not statistically significant in the repeated measures analyses&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;078&#46;</p><elsevierMultimedia ident="tbl0025"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Discussion</span><p id="par0100" class="elsevierStylePara elsevierViewall">Overall results showed that treatment with high dose RBV combined with peginterferon was not more effective than standard treatment in patients with HCV genotype 3 and high viral load&#46; This regimen was safe&#44; as the incidence of related adverse events was not higher compared to patients on standard dose treatment&#46; It is interesting that high RBV doses did not increase the incidence of anemia in arm B2 suggesting that epoetin &#946; effectively prevented RBV-induced anemia<a class="elsevierStyleCrossRefs" href="#bib0090"><span class="elsevierStyleSup">18&#8211;20</span></a>&#46; Although RVR has been shown to be the strongest predictor of SVR<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a>&#44; and in the current study it was associated with SVR in the univariate analysis&#44; this did not reach formal statistical significance in the multivariate analysis&#44; which may be due to the high rate of RVR in both arms&#46; The SVR rates found in this study were higher than those reported by Schiffman et al&#46; in 24-week therapy<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a>&#46; One possible explanation is that most of our patients were Caucasian and Asian&#44; and patients from these ethnic backgrounds have consistently achieved higher SVR rates in previous studies<a class="elsevierStyleCrossRefs" href="#bib0110"><span class="elsevierStyleSup">22&#8211;25</span></a>&#46; Nevertheless&#44; the subgroup of patients without RVR who received high dose RBV achieved the same SVR rate as those who achieved RVR with the standard RBV dose&#46; Although there is no trend indicating overall therapeutic advantage in arm B&#44; twice as many patients in arm B2 achieved SVR compared with non-RVR patients in arm A &#40;61&#46;5&#37; vs&#46; 33&#37;&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;25&#41; suggesting that high-dose RBV may be effective for the sub-group of patients with HCV genotype 3 and high viral load who failed to achieve RVR&#44; but this needs to be examined as the primary end-point in an adequately-powered prospective study&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">Logistic regression analysis showed that SVR was independently associated with age and BMI&#46; The influence of age older than 40&#8211;45 years and weight over 75<span class="elsevierStyleHsp" style=""></span>kg as factors related to a negative response has been previously found in hepatitis C patients<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;7</span></a>&#46; The negative influence of a high BMI could be due to the fixed RBV dose in each group&#44; which was not weight-based&#44; and may have caused heavier individuals to achieve relatively lower plasma RBV levels<a class="elsevierStyleCrossRefs" href="#bib0110"><span class="elsevierStyleSup">22&#44;26</span></a>&#46; Previous studies exploring the possibility of reducing the treatment period with weight adjusted doses of ribavirin &#40;sometimes leading to high dosage&#41; have not found any improvement in relapse rates after short treatment either<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">27&#44;28</span></a>&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">More patients with RVR in arm A achieved SVR when compared to patients with RVR in arm B&#46; These results suggest that induction with high dose RBV during the first 4 weeks is not useful for improving SVR rate&#44; and a reduction in the RBV dose at week 4 may even have a negative impact on the SVR&#44; regardless of the cumulative RBV dose received during the first 4 weeks&#46; Recently&#44; extending treatment with peginterferon plus ribavirin from 24 weeks to 48 weeks has not shown a better SVR rate in non-RVR patients&#44; mainly due to the higher rate of dropouts<a class="elsevierStyleCrossRef" href="#bib5005"><span class="elsevierStyleSup">8</span></a>&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">This failure to enhance SVR rates in patients infected with genotype 3&#44; despite variations in periodicity or dosage of the best currently available therapy&#44; highlights the need to find new approaches to address this problem&#46; Our results failed to show a significant advantage for high-dose ribavirin in 24-week therapy over the standard dose treatment in the subgroup of patients with high baseline viral load without RVR&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">Non-RVR genotype 3 patients are a difficult-to-treat group and their cure remains a challenge&#46; New direct antiviral agents&#44; like sofosbuvir&#44; are expected to improve these results<a class="elsevierStyleCrossRefs" href="#bib0145"><span class="elsevierStyleSup">29&#44;30</span></a>&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">Limitations to this study include its non-blinded nature and the low number of patients allocated in arm B2&#46; In addition&#44; the effect of high dose RBV on the SVR rate was overestimated in the calculation of the sample size when planning the trial &#40;75&#37; of predicted SVR&#41;&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">In summary&#44; this trial did not show benefit of high dose ribavirin in patients with chronic hepatitis C genotype 3&#44; high baseline viral load&#44; and no RVR&#46; Nevertheless&#44; this treatment was safe when particular care was taken to prevent anemia&#46; Further studies on the treatment of infection with HCV genotype 3 should explore forthcoming therapeutic possibilities&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Declaration of interest</span><p id="par0135" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleGrantSponsor" id="gs0005">Roche Farma Laboratories</span> financed the Contract Research Organization of this trial&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">CFR</span> has served as a speaker for Roche&#44; consultant and advisory board member for BMS and MSD and an advisory board member for Janssen&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">FJ</span> has served as a speaker for Roche&#44; MSD and Gilead and has served as an advisory board member for Gilead&#46; <span class="elsevierStyleItalic">MRG</span> has served as a speaker&#44; a consultant and an advisory board member for Roche&#44; MSD&#44; BMS&#44; Janssen&#44; Trugene&#44; Abbott&#44; and has received research funding from Gilead&#44; Roche and MSD&#46; <span class="elsevierStyleItalic">JS</span> has served as a speaker&#44; a consultant and an advisory board member for Roche&#44; Janssen and MSD&#46; <span class="elsevierStyleItalic">JLC</span> has served as a speaker&#44; a consultant and an advisory board member for MSD&#44; Janssen&#44; Gilead&#44; and BMS&#44; and has received research funding from Gilead and Roche&#46; <span class="elsevierStyleItalic">RS</span> has served as a speaker&#44; a consultant and an advisory board member for Roche&#44; Janssen&#44; Gilead&#44; BMS&#44; MSD&#44; Novartis&#44; and has received research funding from Roche&#44; Gilead&#44; BMS and MSD&#46; <span class="elsevierStyleItalic">RM&#44; HM&#44; JMN&#44; RB&#44; JMG&#44; LMM&#44; AP&#44; MMP&#44; FJ</span> and <span class="elsevierStyleItalic">TC</span> have nothing to disclose&#46;</p></span></span>"
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        "resumen" => "<span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Less than half of patients with chronic hepatitis C genotype 3 &#40;G3&#41; and high viral load &#40;HVL&#41; without a rapid virological response &#40;RVR&#41; achieve a sustained virological response &#40;SVR&#41; when treated with peginterferon plus ribavirin &#40;RBV&#41;&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0015">Objectives</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">To assess the impact of high doses of RBV on SVR in patients with G3 and HVL&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0020">Methods</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Ninety-seven patients were randomized to receive peginterferon &#945;-2a<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RBV 800<span class="elsevierStyleHsp" style=""></span>mg&#47;day &#40;A&#59; <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>42&#41; or peginterferon &#945;-2a<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RBV 1600<span class="elsevierStyleHsp" style=""></span>mg&#47;day<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>epoetin &#946; 400<span class="elsevierStyleHsp" style=""></span>IU&#47;kg&#47;week SC &#40;B&#59; <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>55&#41;&#46; Patients allocated to group B who achieved RVR continued on RBV &#40;800<span class="elsevierStyleHsp" style=""></span>mg&#47;day&#41; for a further 20 weeks &#40;B1&#59; <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>42&#41; while non-RVR patients received a higher dose of RBV &#40;1600<span class="elsevierStyleHsp" style=""></span>mg&#47;day&#41;<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>epoetin &#946; &#40;B2&#59; <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>13&#41;&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0025">Results</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">RVR was observed in 64&#46;3&#37; of patients in A and in 76&#46;4&#37; in B &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;259&#41;&#46; Intention-to-treat &#40;ITT&#41; analysis showed SVR rates of 64&#46;3&#37; &#40;A&#41; and 61&#46;8&#37; &#40;B&#41;&#44; with a reduction of &#8722;2&#46;5&#37; &#40;&#8722;21&#46;8&#37; to 16&#46;9&#37;&#41; &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;835&#41;&#46; The SVR rate was 61&#46;9&#37; in arm B1 and 61&#46;5&#37; in arm B2&#46; No serious adverse events were reported&#44; and the rate of moderate adverse events was &#60; 5&#37;&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0030">Conclusions</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">G3 patients with high viral load without RVR did not obtain a benefit from a higher dose of RBV&#46; Higher doses of RBV plus epoetin &#946; were safe and well tolerated &#40;Clin Trials Gov <a class="elsevierStyleInterRef" id="intr0005" href="ctgov:NCT00830609">NCT00830609</a>&#41;&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle" id="sect0040">Introducci&#243;n</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Menos de la mitad de los pacientes con hepatitis cr&#243;nica C genotipo 3 &#40;G3&#41; con carga viral elevada y sin respuesta virol&#243;gica r&#225;pida &#40;RVR&#41; alcanzan respuesta virol&#243;gica sostenida &#40;RVS&#41; con peginterfer&#243;n y ribavirina &#40;RBV&#41;&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0045">Objetivos</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Evaluar el impacto de altas dosis de RBV sobre la RVS en pacientes con G3 y carga viral elevada&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0050">M&#233;todos</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Noventa y siete pacientes recibieron asignaci&#243;n aleatoria para tratamiento con peginterfer&#243;n &#945;-2a<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RBV800<span class="elsevierStyleHsp" style=""></span>mg&#47;d&#237;a &#40;A&#59; <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>42&#41; o peginterfer&#243;n &#945;-2a<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RBV 1600<span class="elsevierStyleHsp" style=""></span>mg&#47;d&#237;a<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>epoetina &#946; 400<span class="elsevierStyleHsp" style=""></span>UI&#47;kg&#47;semana SC &#40;B&#59; <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>55&#41;&#46; Los pacientes asignados al grupo B que alcanzaron RVR continuaron con RBV &#40;800<span class="elsevierStyleHsp" style=""></span>mg&#47;d&#237;a&#41; durante 20 semanas m&#225;s &#40;B1&#59; <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>42&#41; mientras que los que no alcanzaron RVR recibieron una dosis m&#225;s alta de RBV &#40;1&#46;600<span class="elsevierStyleHsp" style=""></span>mg&#47;d&#237;a&#41;<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>epoetina &#946; &#40;B2&#59; <span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>13&#41;&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0055">Resultados</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Se observ&#243; RVR en el 64&#44;3&#37; de los pacientes en A y 76&#44;4&#37; en B &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;259&#41;&#46; El an&#225;lisis por intenci&#243;n de tratar&#40;ITT&#41; mostr&#243; una tasa de RVS de 64&#44;3&#37; &#40;A&#41; y 61&#44;8&#37; &#40;B&#41;&#44; con una reducci&#243;n de &#8722;2&#44;5&#37; &#40;&#8722;21&#44;8&#8211;16&#46;9&#37;&#41; &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;835&#41;&#46; La tasa de RVS fue 61&#44;9&#37; en brazo B1 y 61&#44;5&#37; en brazo B2&#46; No se detectaron efectos adversos graves y la tasa de efectos adversos moderados fue &#60;<span class="elsevierStyleHsp" style=""></span>5&#37;&#46;</p> <span class="elsevierStyleSectionTitle" id="sect0060">Conclusiones</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Los pacientes G3 con carga viral elevada sin RVR no obtuvieron beneficio de dosis m&#225;s altas de RBV&#46; Las dosis m&#225;s altas de ribavirina m&#225;s epoetina &#946; fueron seguras y bien toleradas&#46; &#40;Clin Trials Gov <a class="elsevierStyleInterRef" id="intr0010" href="ctgov:NCT00830609">NCT00830609</a>&#41;</p>"
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                  \t\t\t\t">42&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">26&#46;1<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>6&#46;3&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">26&#46;0<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;9&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">26&#46;0<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">15&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;2&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">15&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;3&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#46;256&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
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                  \t\t\t\t">Leucocytes &#40;&#215;10<span class="elsevierStyleSup">3</span>&#47;ml&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">6&#46;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;8&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">6&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;7&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">6&#46;5<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;7&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#46;363&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">190&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>56&#46;3&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">184&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>47&#46;8&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">187&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>51&#46;4&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;581&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">93<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>19&#46;9&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#46;55&nbsp;\t\t\t\t\t\t\n
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                  """
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                  \t\t\t\t" style="border-bottom: 2px solid black"><span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>97&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" style="border-bottom: 2px solid black"><span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>55&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">RVR &#40;&#37;&#41;<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">a</span></a>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">42 &#40;76&#46;4&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t">34 &#40;68&#46;0&#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">&#8722;9&#46;10&#37; &#40;&#8722;28&#46;1&#37; to 9&#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">0&#46;464&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">SVR &#40;intention-to-treat&#41; <span class="elsevierStyleItalic">N</span> &#40;&#37;&#41;<a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">c</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-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">61 &#40;62&#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">27 &#40;64&#46;3&#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">34 &#40;61&#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">&#8722;2&#46;50&#37; &#40;&#8722;21&#46;8&#37; to 16&#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;835&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">Early withdrawal &#40;&#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">5 &#40;5&#46;3&#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;7&#46;1&#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">2 &#40;3&#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="" 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><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;649&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">No&#46; of adverse effects&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">276&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">128&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">148&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><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></tbody></table>
                  """
              ]
              "imagenFichero" => array:1 [
                0 => "xTab449926.png"
              ]
            ]
          ]
          "notaPie" => array:3 [
            0 => array:3 [
              "identificador" => "tblfn0010"
              "etiqueta" => "a"
              "nota" => "<p class="elsevierStyleNotepara" id="npar0010">RVR&#58; rapid viral response&#46; Negative HCV RNA at week 4&#46;</p>"
            ]
            1 => array:3 [
              "identificador" => "tblfn0020"
              "etiqueta" => "b"
              "nota" => "<p class="elsevierStyleNotepara" id="npar0015">These data include only patients who completed the scheduled treatment&#46;</p>"
            ]
            2 => array:3 [
              "identificador" => "tblfn0015"
              "etiqueta" => "c"
              "nota" => "<p class="elsevierStyleNotepara" id="npar0020">SVR&#58; sustained viral response&#46; Negative HCV RNA at week 24&#46;</p>"
            ]
          ]
        ]
        "descripcion" => array:1 [
          "en" => "<p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">Summary of response data in patients included in both treatment arms&#46;</p>"
        ]
      ]
      4 => array:7 [
        "identificador" => "tbl0015"
        "etiqueta" => "Table 3"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
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        "tabla" => array:2 [
          "leyenda" => "<p id="spar0100" class="elsevierStyleSimplePara elsevierViewall">Mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>SD&#44; <span class="elsevierStyleItalic">n</span> &#40;&#37;&#41;&#44; median &#40;P25&#8211;P75&#41;&#46;</p><p id="spar0105" class="elsevierStyleSimplePara elsevierViewall">Liver biopsy or fibroscan was performed in 41 subjects&#44; results were available in 39&#46;</p>"
          "tablatextoimagen" => array:1 [
            0 => array:2 [
              "tabla" => array:1 [
                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
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                  \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><td class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " colspan="3" align="center" valign="\n
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                  \t\t\t\t" style="border-bottom: 2px solid black">SVR</td></tr><tr title="table-row"><td class="td" title="\n
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                  \t\t\t\t\ttop\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">No&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">Yes&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="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">p</span>-Value&nbsp;\t\t\t\t\t\t\n
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                  \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
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                  \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">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>36&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">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>61&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="" 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></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 &#40;years&#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">44&#46;39<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;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">40&#46;86<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#46;66&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;038&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">BMI &#40;kg&#47;m<span class="elsevierStyleSup">2</span>&#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">27&#46;79<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;38&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">25&#46;08<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;17&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;017&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">Hemoglobin &#40;g&#47;dl&#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">15&#46;45<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;22&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">15&#46;31<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;36&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;626&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">Leukocytes&#47;ml&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">3703&#46;78<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3722&#46;43&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">4407&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3433&#46;53&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;348&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">Platelets&#47;ml &#40;&#215;10<span class="elsevierStyleSup">3</span>&#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">112&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>103&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">130&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>96&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;383&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">Cholesterol &#40;mg&#47;dl&#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">136&#46;22<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>60&#46;6&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">119&#46;08<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>78&#46;43&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;264&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">Triglycerides &#40;mg&#47;dl&#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">84&#46;59<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>95&#46;78&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&#46;53<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>56&#46;01&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;256&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">ALT &#40;IU&#47;ml&#41;&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">0&#46;63<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;23&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</td></tr><tr title="table-row"><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Albumin &#40;g&#47;dl&#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">4&#46;42<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;51&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">4&#46;47<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;39&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Creatinine &#40;mg&#47;dl&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;88<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;18&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;86<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;14&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">0&#46;525&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">Baseline HCV-RNA &#40;IU&#47;ml&#41; &#40;&#215;10<span class="elsevierStyleSup">6</span>&#41;&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
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                  \t\t\t\t">2&#46;2 &#40;1&#46;5&#8211;5&#46;9&#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">3&#46;7 &#40;1&#46;4&#8211;9&#46;2&#41;&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">0&#46;296&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">Gender &#40;Male&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">31 &#40;86&#46;1&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">46 &#40;75&#46;4&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#46;300&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">RVR &#40;&#37;&#41;&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
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                  \t\t\t\t">21 &#40;58&#46;3&#37;&#41;&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
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                  \t\t\t\t">48 &#40;78&#46;7&#37;&#41;&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"><span class="elsevierStyleItalic">Fibrosis</span> &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>39&#41;</td></tr><tr title="table-row"><td class="td" title="\n
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                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">4 &#40;28&#46;6&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">8 &#40;36&#46;0&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \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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                  """
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          "leyenda" => "<p id="spar0115" class="elsevierStyleSimplePara elsevierViewall">Variables entered&#58; age&#44; BMI&#44; rapid virological response &#40;RVR&#41; and treatment arm &#40;analysis of 87 patients&#44; BMI missing in 10 patients&#41;&#46;</p>"
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                  \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="center" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">Arm 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="center" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">Arm B&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="center" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">Arm B1&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="center" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">Arm B2&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="center" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">Total&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">Probable&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">95 &#40;74&#46;2&#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">101 &#40;68&#46;2&#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">79 &#40;69&#46;3&#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">22 &#40;64&#46;7&#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">196 &#40;71&#46;0&#37;&#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">Possible&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">21 &#40;16&#46;4&#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;15&#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">18 &#40;15&#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">5 &#40;14&#46;7&#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">44 &#40;15&#46;9&#37;&#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">Doubtful&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;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">0 &#40;0&#46;0&#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;0&#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;0&#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">2 &#40;0&#46;7&#37;&#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">Not related&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">10 &#40;7&#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">24 &#40;16&#46;2&#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">17 &#40;14&#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">7 &#40;20&#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">34 &#40;12&#46;3&#37;&#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  " colspan="6" align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></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">Total&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">128 &#40;100&#46;0&#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">148 &#40;100&#46;0&#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">114 &#40;100&#46;0&#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">34 &#40;100&#46;0&#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">276 &#40;100&#46;0&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
              ]
              "imagenFichero" => array:1 [
                0 => "xTab449927.png"
              ]
            ]
            1 => 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  " colspan="5" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" style="border-bottom: 2px solid black">By drug and treatment arm</td></tr><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">pegIFN&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">RBV&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">pegIFN<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RBV&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">Total&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  " colspan="5" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Arm A</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>Probable&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;80&#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">15 &#40;93&#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">14 &#40;77&#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">95 &#40;81&#46;9&#37;&#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"><span class="elsevierStyleHsp" style=""></span>Possible&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;19&#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">1 &#40;6&#46;3&#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">4 &#40;22&#46;2&#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">21 &#40;18&#46;1&#37;&#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"><span class="elsevierStyleHsp" style=""></span>Total&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">82 &#40;100&#46;0&#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;100&#46;0&#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">18 &#40;100&#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">116 &#40;100&#37;&#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  " colspan="5" align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">p</span>-Value<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;414</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " colspan="5" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " colspan="5" align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">ARM B1</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>Probable&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">59 &#40;86&#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">8 &#40;53&#46;3&#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">12 &#40;85&#46;7&#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">79 &#40;81&#46;4&#37;&#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"><span class="elsevierStyleHsp" style=""></span>Possible&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                      "titulo" => "Hepatitis C&#58; viral and host factors associated with non-response to pegylated interferon plus ribavirin"
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ISSN: 02105705
Original language: English
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es en pt

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