Title |
A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3
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Published in |
SpringerPlus, August 2016
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DOI | 10.1186/s40064-016-2920-z |
Pubmed ID | |
Authors |
Graham R. Foster, Kazuaki Chayama, Wan-Long Chuang, Hugo Fainboim, Martti Farkkila, Adrian Gadano, Giovanni B. Gaeta, Christophe Hézode, Yukiko Inada, Jeong Heo, Hiromitsu Kumada, Sheng-Nan Lu, Patrick Marcellin, Christophe Moreno, Stuart K. Roberts, Simone I. Strasser, Alexander J. Thompson, Joji Toyota, Seung Woon Paik, John M. Vierling, Anna L. Zignego, David Cohen, Fiona McPhee, Megan Wind-Rotolo, Subasree Srinivasan, Matthew Hruska, Heather Myler, Simon D. Portsmouth |
Abstract |
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. 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). 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. 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Philippines | 1 | 25% |
Spain | 1 | 25% |
United States | 1 | 25% |
Unknown | 1 | 25% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 4 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Finland | 1 | 4% |
Unknown | 27 | 96% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Other | 6 | 21% |
Student > Doctoral Student | 3 | 11% |
Student > Bachelor | 2 | 7% |
Researcher | 2 | 7% |
Professor | 2 | 7% |
Other | 4 | 14% |
Unknown | 9 | 32% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 10 | 36% |
Biochemistry, Genetics and Molecular Biology | 3 | 11% |
Economics, Econometrics and Finance | 2 | 7% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 4% |
Mathematics | 1 | 4% |
Other | 0 | 0% |
Unknown | 11 | 39% |