A randomized, controlled study of peginterferon lambda-1a/ribavirin +/- daclatasvir for hepatitis C virus genotype 2 or 3

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Foster , G R , Chayama , K , Chuang , W-L , Fainboim , H , Farkkila , M , Gadano , A , Gaeta , G B , Hezode , C , Inada , Y , Heo , J , Kumada , H , Lu , S-N , Marcellin , P , Moreno , C , Roberts , S K , Strasser , S I , Thompson , A J , Toyota , J , Paik , S W , Vierling , J M , Zignego , A L , Cohen , D , McPhee , F , Wind-Rotolo , M , Srinivasan , S , Hruska , M , Myler , H & Portsmouth , S D 2016 , ' A randomized, controlled study of peginterferon lambda-1a/ribavirin +/- daclatasvir for hepatitis C virus genotype 2 or 3 ' SpringerPlus , vol. 5 , 1365 . DOI: 10.1186/s40064-016-2920-z

Title: A randomized, controlled study of peginterferon lambda-1a/ribavirin +/- daclatasvir for hepatitis C virus genotype 2 or 3
Author: Foster, Graham R.; Chayama, Kazuaki; Chuang, Wan-Long; Fainboim, Hugo; Farkkila, Martti; Gadano, Adrian; Gaeta, Giovanni B.; Hezode, Christophe; Inada, Yukiko; Heo, Jeong; Kumada, Hiromitsu; Lu, Sheng-Nan; Marcellin, Patrick; Moreno, Christophe; Roberts, Stuart K.; Strasser, Simone I.; Thompson, Alexander J.; Toyota, Joji; Paik, Seung Woon; Vierling, John M.; Zignego, Anna L.; Cohen, David; McPhee, Fiona; Wind-Rotolo, Megan; Srinivasan, Subasree; Hruska, Matthew; Myler, Heather; Portsmouth, Simon D.
Contributor: University of Helsinki, Department of Medicine
Date: 2016-08-19
Language: eng
Number of pages: 12
Belongs to series: SpringerPlus
ISSN: 2193-1801
URI: http://hdl.handle.net/10138/166664
Abstract: Background and purpose: Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. We compared peginterferon Lambda-1a plus ribavirin (Lambda/RBV) and Lambda/RBV plus daclatasvir (DCV; pangenotypic NS5A inhibitor) with peginterferon alfa-2a plus RBV (alfa/RBV) in treatment-naive patients with HCV genotype 2 or 3 infection. Methods: In this multicenter, double-blind, phase 3 randomized controlled trial, patients were assigned 2:2:1 to receive 24 weeks of Lambda/RBV, 12 weeks of Lambda/RBV + DCV, or 24 weeks of alfa/RBV. The primary outcome measure was sustained virologic response at post-treatment Week 12 (SVR12). Results: Overall, 874 patients were treated: Lambda/RBV, n = 353; Lambda/RBV + DCV, n = 349; alfa/RBV, n = 172. Patients were 65 % white and 33 % Asian, 57 % male, with a mean age of 47 years; 52 % were infected with genotype 2 (6 % cirrhotic) and 48 % with genotype 3 (9 % cirrhotic). In the Lambda/RBV + DCV group, 83 % (95 % confidence interval [CI] 78.5, 86.5) achieved SVR12 (90 % genotype 2, 75 % genotype 3) whereas SVR12 was achieved by 68 % (95 % CI 63.1, 72.9) with Lambda/RBV (72 % genotype 2, 64 % genotype 3) and 73 % (95 % CI 66.6, 79.9) with peginterferon alfa/RBV (74 % genotype 2, 73 % genotype 3). Lambda/RBV + DCV was associated with lower incidences of flu-like symptoms, hematological abnormalities, and discontinuations due to adverse events compared with alfa/RBV. Conclusion: The 12-week regimen of Lambda/RBV + DCV was superior to peginterferon alfa/RBV in the combined population of treatment-naive patients with genotype 2 or 3 infection, with an improved tolerability and safety profile compared with alfa/RBV.
Subject: Hepatitis C virus
Genotype 2
Genotype 3
Peginterferon lambda-1a
Peginterferon alfa-2a
PLUS SOFOSBUVIR
HCV GENOTYPE-2
RIBAVIRIN
THERAPY
INFECTION
CIRRHOSIS
3121 Internal medicine
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