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Daclatasvir, sofosbuvir with or without ribavirin for 24 weeks in hepatitis C genotype 3 cirrhosis: A real-life study
Raffaella Lionettia,
Corresponding author
raffaella.lionetti@inmi.it

Corresponding author at: Liver and Infectious Diseases, Lazzaro Spallanzani National Institute for Infectious Disease, Via portuense 292, 00149 Rome, Italy.
, Paola Piccolob,c, Ilaria Lencic, Massimo Sicilianod, Ubaldo Visco-Comandinia, Adriano De Santise, Maurizio Pompilid, Martina Milanac, Chiara Taibia, Serena Dell’Isolaf, Marzia Montalbanoa, Claudio Mastroiannig, Paola Beginih, Anna Rosa Garbugliai, Mario Angelicoc, Gianpiero D’Offizia
a Liver and Infectious Diseases, Lazzaro Spallanzani National Institute for Infectious Disease, Rome, Italy
b Internal Medicine Unit, Fatebenefratelli Hospital Isola Tiberina, Rome, Italy
c Liver Unit, Tor Vergata University Hospital, Rome, Italy
d Gastroenterology and Liver Unit, Policlinico Gemelli, Catholic University, Rome, Italy
e Gastroenterology and Liver Unit, Policlinico Umberto I, Sapienza University, Rome, Italy
f Medicina Protetta-Infectious Diseases, Belcolle Hospital, Viterbo, Italy
g Infectious Diseases, Policlinico Umberto I, Sapienza University, Rome, Italy
h Liver Unit, Sant’Andrea University Hospital, Rome, Italy
i Laboratory of Virology, Lazzaro Spallanzani National Institute for Infectious Disease, Rome, Italy
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleLabel">1</span><span class="elsevierStyleSectionTitle" id="sect0035">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Chronic hepatitis C virus &#40;HCV&#41; infection is the main cause of chronic liver disease in Italy&#44; where although the exact number of infected subjects is unknown&#44; a prevalence of approximately 1&#37; is estimated in the general population <a class="elsevierStyleCrossRef" href="#bib0105">&#91;1&#93;</a>&#46; By February 2017 roughly 70&#44;000 infected patients had been treated with new direct antiviral agents &#40;DAA&#41;&#58; initially only patients with advanced liver disease&#44; transplanted recipients or with extrahepatic manifestations were eligible to receive DAAs&#46; Of these&#44; approximately 43&#44;450 cirrhotics were treated with an overall sustained virological response &#40;SVR&#41; higher than 90&#37; <a class="elsevierStyleCrossRef" href="#bib0105">&#91;1&#93;</a>&#46; However even with these new regimens cirrhotic patients&#44; especially if infected by HCV genotype &#40;G&#41; 3&#44; remain difficult to treat&#46; HCV G3 is the second most prevalent genotype worldwide with an estimated prevalence of 30&#37; among all HCV infected subjects in Europe <a class="elsevierStyleCrossRefs" href="#bib0110">&#91;2&#44;3&#93;</a>&#46; G3 is associated with a higher risk of steatosis and hepatocellular carcinoma &#40;HCC&#41; <a class="elsevierStyleCrossRef" href="#bib0120">&#91;4&#93;</a>&#46; The first interferon-free combination based on sofosbuvir &#40;SOF&#41; plus ribavirin &#40;RBV&#41; for 24 weeks reached suboptimal SVR rates in cirrhotic patients <a class="elsevierStyleCrossRefs" href="#bib0125">&#91;5&#44;6&#93;</a>&#44; leading to a search for other alternative combination regimens&#46; The combination of SOF plus daclatasvir &#40;DCV&#41; for 24 weeks instead of 12 was recommended based on expert opinion <a class="elsevierStyleCrossRef" href="#bib0135">&#91;7&#93;</a>&#44; as no data from randomized clinical trials in cirrhotic patients have been published in the Italian patient population&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">The ALLY-3 trial demonstrated a very low SVR rate &#40;approximately 60&#37;&#41; among G3 cirrhotic patients treated with SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV without RBV for 12 weeks <a class="elsevierStyleCrossRef" href="#bib0140">&#91;8&#93;</a>&#59; the extension of treatment duration to 16 weeks&#44; and the addition of RBV in the only randomized study ALLY-3&#43; increased SVR to 86&#37; <a class="elsevierStyleCrossRef" href="#bib0145">&#91;9&#93;</a>&#46; Three Italian real-life studies published in abstract form <a class="elsevierStyleCrossRefs" href="#bib0150">&#91;10&#8211;12&#93;</a> reported an increase of SVR to 90&#8211;98&#37; with 24 weeks&#8217; duration and some benefit from RBV administration&#46; Also data produced by the UK EAP confirmed how RBV is significantly associated with SVR12 in G3 cirrhotic patients <a class="elsevierStyleCrossRef" href="#bib0165">&#91;13&#93;</a>&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Given the lack of clear-cut data regarding the ideal antiviral regimen in HCV G3 cirrhotic patients&#44; the present study aims to investigate the efficacy and safety of a 24 week course of SOF plus DCV with or without RBV in this difficult-to-treat population&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleLabel">2</span><span class="elsevierStyleSectionTitle" id="sect0040">Methods</span><p id="par0020" class="elsevierStylePara elsevierViewall">This was a prospective multicenter study conducted in 8 tertiary hepatology centers in Lazio region&#44; Italy from June 2015 to October 2016&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Eligibility criteria were&#58; adult patients &#40;age<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>18 years&#41; with HCV G3 infection and clinical evidence of cirrhosis&#46; Diagnosis of cirrhosis was made based on liver biopsy or non-invasive fibrosis testing &#40;liver stiffness measurement through transient elastography&#41;&#46; Cirrhosis was defined histologically by a METAVIR score of F4 on biopsy or non-invasively by a liver stiffness &#62;14<span class="elsevierStyleHsp" style=""></span>kPa&#46; Patients with decompensated cirrhosis were also included&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Treatment experienced patients were allowed with the exception of prior use of NS5A inhibitors&#46; Patients who had been treated with SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RBV were included except for those who discontinued therapy for intolerance&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Exclusion criteria were&#58; previous treatment with NS5A inhibitors&#44; HCC beyond Milan criteria&#44; renal insufficiency &#40;glomerular filtration rate &#60;30<span class="elsevierStyleHsp" style=""></span>ml&#47;min&#41;&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">All patients received SOF 400<span class="elsevierStyleHsp" style=""></span>mg plus DCV 60<span class="elsevierStyleHsp" style=""></span>mg orally daily for 24 weeks as authorized by the Italian Medical Agency &#40;AIFA&#41;&#46; RBV was prescribed at physicians&#8217; discretion&#44; based on clinical features &#40;i&#46;e&#46;&#44; previous decompensation&#44; baseline hemoglobin levels&#41; and&#47;or expected tolerability &#40;i&#46;e&#46;&#44; previous RBV therapy&#41;&#46; The study was conducted in accord with the principles of good clinical practice and the declaration of Helsinki&#44; and all patients provided written informed consent&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Genotyping was performed using the real time HCV genotype II assay &#40;Abbott Molecular&#44; Des Plaines IL&#44; USA&#41;&#59; quantitative HCV RNA levels were assessed at baseline&#44; at treatment weeks 4&#44; 12&#44; 24 and at post treatment weeks 4&#44; 12 using the HCV Abbott real time polymerase chain reaction &#40;PCR&#41; with a lower limit of quantification of 12<span class="elsevierStyleHsp" style=""></span>IU&#47;ml&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">SVR12 was defined as undetectable HCV RNA at 12 weeks after treatment completion&#46; Safety and tolerability were recorded at every visit&#46; Resistance testing for variants &#40;RAVs&#41; in both NS5A and NS5B regions were performed by sequencing plasma HCV RNA from any patient who experienced virological relapse during and post-treatment&#46;</p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleLabel">2&#46;1</span><span class="elsevierStyleSectionTitle" id="sect0045">Statistical analysis</span><p id="par0055" class="elsevierStylePara elsevierViewall">A descriptive analysis was performed for socio-demographic parameters&#44; as well as clinical variables related to liver function at baseline&#46; Mean&#44; standard deviation&#44; range&#44; median&#44; interquartile range&#44; number of missing data&#44; and 95&#37; confidence intervals were determined for continuous variables&#59; absolute frequency&#44; 95&#37; confidence intervals and number of missing data for categorical variables&#46; Associations between qualitative variables were measured with a <span class="elsevierStyleItalic">&#967;</span><span class="elsevierStyleSup">2</span> test&#44; while differences between quantitative variables were evaluated with a Student&#39;s <span class="elsevierStyleItalic">t</span> test&#46; Statistical computations were performed with the SPSS<span class="elsevierStyleSup">&#174;</span> Statistics package version 20&#46;0&#46;0&#46; Data were analyzed according to intention to treat &#40;ITT&#41;&#46;</p></span></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleLabel">3</span><span class="elsevierStyleSectionTitle" id="sect0050">Results</span><p id="par0060" class="elsevierStylePara elsevierViewall">106 G3 cirrhotic patients were enrolled &#40;70&#46;8&#37; males&#44; mean age 55&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#46;6 years&#41;&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Baseline Child-Pugh class was as follows&#58; A 91&#46;5&#37;&#44; B 6&#46;6&#37;&#44; C 1&#46;9&#37;&#46; Baseline characteristics are listed in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0070" class="elsevierStylePara elsevierViewall">According to previous antiviral treatment 61&#37; patients were na&#239;ve&#44; 39&#37; were treatment-experienced &#40;22 relapsers and 19 non-responders to peginterferon plus ribavirin&#41;&#46; Only 1 patient had previously received SOF&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">Eighty-five patients received RBV &#40;80&#46;2&#37;&#41; while 21 received only SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV &#40;19&#46;8&#37;&#41;&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">Mean RBV dose was 964<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>202<span class="elsevierStyleHsp" style=""></span>mg&#47;daily&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">Baseline characteristics between the two treatment groups &#40;with or without RBV&#41; showed a significantly younger age and a lower baseline MELD among RBV-treated patients &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;008 and 0&#46;017&#44; respectively&#59; <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; Nine patients with decompensated cirrhosis &#40;Child-Pugh class B and C at baseline&#41; all had ascites&#59; 27 patients &#40;25&#46;5&#37;&#41; had esophageal varices at baseline&#46; Mean pre-treatment liver stiffness measurement was 23&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#46;4<span class="elsevierStyleHsp" style=""></span>kPa&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">All patients completed 24 weeks of treatment with SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>RBV&#46; No patient was lost to follow-up and safety data was recorded at every scheduled or on-demand visit&#46;</p><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleLabel">3&#46;1</span><span class="elsevierStyleSectionTitle" id="sect0055">Virological results</span><p id="par0095" class="elsevierStylePara elsevierViewall">All patients were HCV RNA negative at end of treatment and SVR was obtained in 104&#47;106 patients overall &#40;98&#46;1&#37;&#41; while SVR was 100&#37; and 90&#46;4&#37; in the SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RBV and SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV group&#44; respectively &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;04&#41;&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">SVR based on Child-Pugh class at baseline showed a statistically significant difference for class A patients vs&#46; class B patients &#40;98&#46;9&#37; vs&#46; 85&#46;7&#37; respectively&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;01&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0105" class="elsevierStylePara elsevierViewall">Two patients relapsed during follow-up&#59; both received SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV and had obtained serum HCV RNA undetectability at week 4 of therapy&#46; The first patient was non-responder to a previous IFN-based therapy&#44; with good residual liver function &#40;Child-Pugh class A&#44; MELD 8&#41; and 5 log serum HCV RNA at baseline&#46; The second relapser was na&#239;ve&#44; with decompensated liver disease &#40;Child-Pugh class B&#44; MELD 15&#41; refractory ascites and 4 log serum HCV RNA at baseline&#46; The analysis of RAVs at post treatment week 12&#44; showed the development of Y93H in both patients and S282T in the latter only&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleLabel">3&#46;2</span><span class="elsevierStyleSectionTitle" id="sect0060">Liver and kidney function</span><p id="par0110" class="elsevierStylePara elsevierViewall">Overall no worsening in liver and kidney function was observed between baseline and end of follow-up&#59; a increase in MELD score was found at end of treatment vs&#46; baseline in patients who received ribavirin &#40;<a class="elsevierStyleCrossRefs" href="#tbl0010">Table 2</a>&#41;&#44; and returned to baseline levels at end of follow-up&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0115" class="elsevierStylePara elsevierViewall">No significant variations in INR&#44; serum bilirubin&#44; creatinine level were seen between baseline and end of follow-up within each of the 2 treatment groups &#40;<a class="elsevierStyleCrossRefs" href="#tbl0010">Table 2</a>&#41;&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">No significant variations in INR&#44; serum bilirubin&#44; creatinine level and MELD were seen between the 2 treatment groups&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">No compensated patient experienced decompensation during treatment and follow-up&#46; Two patients with decompensated cirrhosis &#40;baseline Child-Pugh class C&#41; remained stable during treatment and follow-up with no worsening in MELD score&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleLabel">3&#46;3</span><span class="elsevierStyleSectionTitle" id="sect0065">Safety</span><p id="par0130" class="elsevierStylePara elsevierViewall">SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>RBV combination was well tolerated&#46; All patients completed treatment without any early discontinuations due to adverse events &#40;AEs&#41;&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">The most common reported AE was grade 1&#8211;2 anemia in 30 patients in the SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RBV group &#40;35&#46;3&#37;&#41;&#44; requiring RBV dose reduction in 10 patients &#40;11&#46;7&#37;&#41;&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">Overall 8 patients reported headache and irritability &#40;7&#46;5&#37;&#59; 2 in SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV group and 6 patients in SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RBV group&#44; respectively&#41;&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">Total AEs were significantly more common in the SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RBV group &#40;42&#46;3&#37; vs&#46; 9&#46;5&#37;&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;01&#41;&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">No serious AEs were observed during treatment and follow-up&#46;</p></span></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleLabel">4</span><span class="elsevierStyleSectionTitle" id="sect0070">Discussion</span><p id="par0155" class="elsevierStylePara elsevierViewall">This real-life clinical study demonstrates an excellent safety and efficacy of SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV combination in a difficult-to-treat population of cirrhotic patients infected by HCV G3&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">The extension of therapy to 24 weeks with the addition of RBV&#44; both proposed by Italian AIFA rules and empirically suggested by EASL guidelines&#44; allowed to achieve a higher SVR rate compared to a published randomized controlled trial with a treatment duration of 16 weeks&#46; In fact in the present study G3 cirrhotic patients obtained an overall SVR rate of 98&#46;1&#37; compared to 86&#37; reported in the ALLY-3&#43; trial <a class="elsevierStyleCrossRef" href="#bib0145">&#91;9&#93;</a>&#46; This virological improvement appears to be even more significant if one compares data from RBV-treated patients in both studies&#58; 100&#37; in the present work vs&#46; 86&#37; in ALLY-3&#43;&#46; Therefore our data underscores the importance of prolonging treatment duration to 24 weeks&#44; as well as adding RBV when feasible&#44; to obtain an improvement in SVR&#46; These findings are supported by and consistent with other three reports in abstract form from other Italian regions <a class="elsevierStyleCrossRefs" href="#bib0150">&#91;10&#8211;12&#93;</a> and two European studies <a class="elsevierStyleCrossRefs" href="#bib0165">&#91;13&#44;14&#93;</a>&#46; The beneficial role of RBV in treating G3 cirrhotic patients is in fact suggested by improved virological rates in RBV-containing regimens also in the UK EAP study though the total number of patients treated without RBV was small and robust conclusion cannot be drawn <a class="elsevierStyleCrossRef" href="#bib0165">&#91;13&#93;</a>&#46; Similar results are reported in the Scandinavian study where the addition of RBV even for 12 weeks&#8217; treatment showed a trend toward higher SVR12 <a class="elsevierStyleCrossRef" href="#bib0170">&#91;14&#93;</a>&#46; However&#44; our results are in contrast with a sub-analysis of an heterogeneous French early access program study by Hezode et al&#46;&#44; which showed a lower SVR rates in 205 G3 cirrhotic patients treated for 24 weeks with the same regimens&#58; SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV had 86&#37; SVR12&#44; while SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RBV had 82&#37; SVR12 <a class="elsevierStyleCrossRef" href="#bib0175">&#91;15&#93;</a>&#46; Therefore&#44; in the study by Hezode et al&#46;&#44; neither the extension of duration to 24 weeks&#44; nor the addition of RBV appeared to improve SVR rates&#46; A possible explanation for this difference in SVR&#44; could be the characteristics of the French cirrhotic population which showed a higher rate of decompensated cirrhosis &#40;15&#37; vs&#46; 8&#46;5&#37; in the present study&#41; and a baseline MELD &#62;15 in 30&#37; of patients&#46; Both these factors are known to negatively impact prognosis for virological success&#46; Furthermore&#44; baseline liver function was more severely impaired in the French population&#44; accounting for the higher number of serious AEs in the group treated with RBV&#46; All reported deaths and serious AEs were&#44; in fact&#44; observed only in patients with a baseline MELD &#8805;15&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">In contrast our patients&#44; who showed both a lower baseline MELD and lower rate of decompensated cirrhosis&#44; did not experience serious AEs&#59; no discontinuation of any of the study drugs was needed and only 11&#46;7&#37; required RBV dose reduction&#46; Anemia was the most frequent AE but was low grade and easily managed without the need for red blood cell transfusion or erythropoietin support&#46; Furthermore although the study population was smaller than the French study&#44; there was no missing data&#44; and all patients completed all scheduled visits&#46;</p><p id="par0170" class="elsevierStylePara elsevierViewall">A limitation of our study is the lack of randomization for treatment assignment regarding RBV&#44; whereas treatment duration was the same in all patients&#46; RBV was added based on physician&#39;s discretion&#44; which can represent a possible bias&#46; However RBV administration was discretionary by the treating clinician in all published studies of cirrhotic patients&#44; due to variability of residual liver function across Child-Pugh classes and safety concerns regarding risk of decompensation <a class="elsevierStyleCrossRefs" href="#bib0165">&#91;13&#8211;15&#93;</a>&#46; The selection of patients who can benefit from RBV must take into account both pre-treatment SVR likelihood as well predicted tolerability&#46; In the present study RBV was prescribed to patients with better residual liver function who were more likely to tolerate 24 weeks of treatment&#46;</p><p id="par0175" class="elsevierStylePara elsevierViewall">As the field of antiviral therapies is in continuous and accelerated development&#44; shorter successful RBV-free regimens are now available with second generation DAAs&#44; as reported in the ASTRAL-3 and POLARIS-3 trials <a class="elsevierStyleCrossRefs" href="#bib0180">&#91;16&#44;17&#93;</a>&#59; a post hoc analysis of a second generation RBV-free DAA regimen based on SOF and velpatasvir &#40;VEL&#41; achieved high SVR rates&#44; though extremely variable &#40;86&#8211;98&#37;&#41; depending on patient characteristics especially among different stages of liver function <a class="elsevierStyleCrossRefs" href="#bib0180">&#91;16&#44;17&#93;</a>&#46; In ASTRAL-4 decompensated cirrhosis patients infected with all genotypes were treated with 12 weeks of SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>VEL with or without RBV&#44; or with 24 weeks of SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>VEL&#59; addition of RBV increased SVR to a greater extent than 24 weeks&#8217; duration&#44; particularly in G3 infected patients&#44; though in a small sample of patients &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>13&#41; <a class="elsevierStyleCrossRef" href="#bib0190">&#91;18&#93;</a>&#46; However&#44; these regimens still need validation in real-life clinical practice studies&#44; having been made available only recently&#46;</p><p id="par0180" class="elsevierStylePara elsevierViewall">Newer upcoming drug combinations such as glecaprevir&#47;pibrentasvir or Mk3 have also shown promise in G3 infected patients&#44; including cirrhotics <a class="elsevierStyleCrossRefs" href="#bib0195">&#91;19&#44;20&#93;</a>&#46; Further clinical experience in larger cohorts of patients will be necessary to verify the safety profiles of these newer drug combinations&#46;</p><p id="par0185" class="elsevierStylePara elsevierViewall">In conclusion our data shows that the combination of SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>RBV for 24 weeks in compensated G3 cirrhotic patients achieves excellent virological results&#44; with a 98&#46;1&#37; SVR12 rate&#44; and an excellent safety profile&#46;</p></span><span id="sec9045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Abbreviations</span><p id="par9185" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleDefList"><span class="elsevierStyleDefTerm">HCV</span><span class="elsevierStyleDefDescription"><p id="par0190" class="elsevierStylePara elsevierViewall">hepatitis C virus</p></span><span class="elsevierStyleDefTerm">DAA</span><span class="elsevierStyleDefDescription"><p id="par0195" class="elsevierStylePara elsevierViewall">direct antiviral agent</p></span><span class="elsevierStyleDefTerm">SVR</span><span class="elsevierStyleDefDescription"><p id="par0200" class="elsevierStylePara elsevierViewall">sustained virological response</p></span><span class="elsevierStyleDefTerm">G</span><span class="elsevierStyleDefDescription"><p id="par0205" class="elsevierStylePara elsevierViewall">genotype</p></span><span class="elsevierStyleDefTerm">HCC</span><span class="elsevierStyleDefDescription"><p id="par0210" class="elsevierStylePara elsevierViewall">hepatocellular carcinoma</p></span><span class="elsevierStyleDefTerm">SOF</span><span class="elsevierStyleDefDescription"><p id="par0215" class="elsevierStylePara elsevierViewall">sofosbuvir</p></span><span class="elsevierStyleDefTerm">RBV</span><span class="elsevierStyleDefDescription"><p id="par0220" class="elsevierStylePara elsevierViewall">ribavirin</p></span><span class="elsevierStyleDefTerm">DCV</span><span class="elsevierStyleDefDescription"><p id="par0225" class="elsevierStylePara elsevierViewall">daclatasvir</p></span><span class="elsevierStyleDefTerm">AIFA</span><span class="elsevierStyleDefDescription"><p id="par0230" class="elsevierStylePara elsevierViewall">Agenzia Italiana del Farmaco &#40;Italian Medicine Agency&#41;</p></span><span class="elsevierStyleDefTerm">RNA</span><span class="elsevierStyleDefDescription"><p id="par0235" class="elsevierStylePara elsevierViewall">ribonucleic acid</p></span><span class="elsevierStyleDefTerm">PCR</span><span class="elsevierStyleDefDescription"><p id="par0240" class="elsevierStylePara elsevierViewall">polymerase chain reaction</p></span><span class="elsevierStyleDefTerm">RAV</span><span class="elsevierStyleDefDescription"><p id="par0245" class="elsevierStylePara elsevierViewall">resistance-associated variants</p></span><span class="elsevierStyleDefTerm">NS</span><span class="elsevierStyleDefDescription"><p id="par0250" class="elsevierStylePara elsevierViewall">non-structural</p></span><span class="elsevierStyleDefTerm">MELD</span><span class="elsevierStyleDefDescription"><p id="par0255" class="elsevierStylePara elsevierViewall">model for end-stage liver disease</p></span><span class="elsevierStyleDefTerm">AE</span><span class="elsevierStyleDefDescription"><p id="par0260" class="elsevierStylePara elsevierViewall">adverse event</p></span><span class="elsevierStyleDefTerm">EASL</span><span class="elsevierStyleDefDescription"><p id="par0265" class="elsevierStylePara elsevierViewall">European Association for the Study of the Liver</p></span><span class="elsevierStyleDefTerm">VEL</span><span class="elsevierStyleDefDescription"><p id="par0270" class="elsevierStylePara elsevierViewall">velpatasvir</p></span></span></p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Conflict of interest</span><p id="par0275" class="elsevierStylePara elsevierViewall">None declared&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Financial support</span><p id="par0280" class="elsevierStylePara elsevierViewall">None declared&#46;</p></span></span>"
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          "titulo" => "Conflict of interest"
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        8 => array:2 [
          "identificador" => "sec0050"
          "titulo" => "Financial support"
        ]
        9 => array:1 [
          "titulo" => "References"
        ]
      ]
    ]
    "pdfFichero" => "main.pdf"
    "tienePdf" => true
    "fechaRecibido" => "2018-04-03"
    "fechaAceptado" => "2018-09-05"
    "PalabrasClave" => array:1 [
      "en" => array:1 [
        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Keywords"
          "identificador" => "xpalclavsec1117474"
          "palabras" => array:3 [
            0 => "Antiviral therapy"
            1 => "Advanced fibrosis"
            2 => "Tolerability"
          ]
        ]
      ]
    ]
    "tieneResumen" => true
    "resumen" => array:1 [
      "en" => array:3 [
        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction and aim</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Cirrhotic patients with hepatitis C virus genotype 3 infection show unsatisfactory outcomes after 12 weeks&#8217; treatment with direct antiviral agents&#46; The National Italian Drug Agency allows 24 weeks of therapy in difficult-to-treat patients&#44; including genotype 3 cirrhotics&#46; Aim of this study was to evaluate efficacy and safety of a 24-week course of sofosbuvir plus daclatasvir<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>ribavirin in this population&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Materials and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">106 consecutive cirrhotics &#40;70&#46;8&#37; males&#44; mean age 55&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#46;6 years&#41; in 8 tertiary hepatology centers received sofosbuvir plus daclatasvir for 24 weeks&#46; Ribavirin was administered in 85 &#40;80&#46;2&#37;&#41; based expected tolerability&#44; at a mean dose of 964<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>202<span class="elsevierStyleHsp" style=""></span>mg&#47;day&#46; Baseline Child-Pugh class was A 91&#46;5&#37;&#44; B 6&#46;6&#37;&#44; C 1&#46;9&#37;&#59; mean baseline MELD was 8&#46;5<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>2&#46;7&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">All patients completed 12-week follow-up post-treatment&#44; and 104 &#40;98&#46;1&#37;&#41; obtained sustained virological response &#40;100&#37; in ribavirin -treated patients vs&#46; 90&#46;4&#37; without ribavirin&#59; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;04&#41;&#46; No worsening in renal and liver function was observed&#44; no serious adverse events occurred&#46; Two virological failures showed resistance associated variants &#40;Y93H and S282T&#41;&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">An extended 24-week treatment with sofosbuvir plus daclatasvir<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>ribavirin obtained 100&#37; efficacy in genotype 3 hepatitis C cirrhosis&#44; with very limited side effects&#46; The role of ribavirin seems crucial in this setting and should be administered if clinically feasible&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Introduction and aim"
          ]
          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "Materials and methods"
          ]
          2 => array:2 [
            "identificador" => "abst0015"
            "titulo" => "Results"
          ]
          3 => array:2 [
            "identificador" => "abst0020"
            "titulo" => "Conclusion"
          ]
        ]
      ]
    ]
    "multimedia" => array:4 [
      0 => array:7 [
        "identificador" => "fig0005"
        "etiqueta" => "Fig&#46; 1"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
            "imagen" => "gr1.jpeg"
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        "descripcion" => array:1 [
          "en" => "<p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Sustained virological response &#40;SVR&#41; rates in cirrhotic patients infected with hepatitis C virus genotype 3 treated with sofosbuvir plus daclatasvir with or without ribavirin according to Child-Pugh class at baseline&#46; Patients in Child-Pugh class A overall had significantly higher SVR rated compared to Child-Pugh class B patients &#40;&#42;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;01&#41;&#46;</p> <p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">SOF&#44; sofosbuvir&#59; DCV&#44; daclatasvir&#59; RBV&#44; ribavirin&#46;</p>"
        ]
      ]
      1 => array:8 [
        "identificador" => "tbl0005"
        "etiqueta" => "Table 1"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
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        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at1"
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          "leyenda" => "<p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">SOF&#44; sofosbuvir&#59; DCV&#44; daclatasvir&#59; RBV&#44; ribavirin&#59; BMI&#44; body mass index&#59; MELD&#44; model for end-stage liver disease&#59; ALT&#44; alanine aminotransferase&#59; PLT&#44; platelet count&#59; INR&#44; international normalized ratio&#46;</p>"
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Overall &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>106&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">SOF<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>DCV<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>RBV &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>85&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">55&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#46;6&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">51<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#46;4<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">56<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;3<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">75 &#40;70&#46;8&#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="left" valign="\n
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                  \t\t\t\t">57 &#40;67&#46;1&#41;&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 ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>&#60;25&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">49 &#40;46&#46;7&#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">40 &#40;47&#46;1&#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="left" valign="\n
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                  \t\t\t\t">9 &#40;42&#46;9&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>25&#8211;30&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="left" valign="\n
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                  \t\t\t\t">45 &#40;42&#46;9&#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="left" valign="\n
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                  \t\t\t\t">36 &#40;42&#46;4&#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="left" valign="\n
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                  \t\t\t\t">10 &#40;47&#46;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>&#62;35&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
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                  \t\t\t\t">11 &#40;10&#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="left" valign="\n
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                  \t\t\t\t">9 &#40;10&#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="left" valign="\n
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                  \t\t\t\t">2 &#40;9&#46;5&#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">&nbsp;\t\t\t\t\t\t\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
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>&#60;800&#44;000<span class="elsevierStyleHsp" style=""></span>IU&#47;ml&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
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                  \t\t\t\t">65 &#40;61&#46;3&#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="left" valign="\n
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                  \t\t\t\t">51 &#40;60&#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="left" valign="\n
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                  \t\t\t\t">14 &#40;66&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>&#62;800&#44;000<span class="elsevierStyleHsp" style=""></span>IU&#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="left" valign="\n
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                  \t\t\t\t">41 &#40;38&#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="left" valign="\n
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                  \t\t\t\t">34 &#40;40&#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="left" valign="\n
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                  \t\t\t\t">7 &#40;33&#46;3&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">8&#46;5<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>2&#46;7&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
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                  \t\t\t\t">8&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>2&#46;3<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">&#42;&#42;</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
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Mean ALT IU&#47;ml</span>&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">103<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>84&#46;6&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">118&#44;935<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>59&#44;513&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">1&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;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="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#46;18<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;2&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">1&#46;25<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;3&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">1&#46;1<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;9&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="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#46;06<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;9&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">1&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttop\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">0&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;15&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="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;16&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="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
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                  \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><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-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>A&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">97 &#40;91&#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="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">78 &#40;91&#46;8&#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="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">19 &#40;90&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>B&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
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                  \t\t\t\t">7 &#40;6&#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
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                  \t\t\t\t">6 &#40;7&#46;1&#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="left" valign="\n
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                  \t\t\t\t">1 &#40;4&#46;8&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>C&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">2 &#40;1&#46;9&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">1&#46;18<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;2&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">1&#46;2<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;18&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&#46;15<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;18&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Bilirubin mg&#47;dl&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">1&#46;1<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;9<a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">1&#46;18<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;06&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#46;95<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;84<a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">&#42;</span></a>&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">0&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;16&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;16&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">8&#46;3<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>2&#46;3<a class="elsevierStyleCrossRef" href="#tblfn0020"><span class="elsevierStyleSup">&#42;&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
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ISSN: 16652681
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es en pt

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?

Você é um profissional de saúde habilitado a prescrever ou dispensar medicamentos