作者
Michael Manns, Stanislas Pol, Ira M Jacobson, Patrick Marcellin, Stuart C Gordon, Cheng-Yuan Peng, Ting-Tsung Chang, Gregory T Everson, Jeong Heo, Guido Gerken, Boris Yoffe, William J Towner, Marc Bourliere, Sophie Metivier, Chi-Jen Chu, William Sievert, Jean-Pierre Bronowicki, Dominique Thabut, Youn-Jae Lee, Jia-Horng Kao, Fiona McPhee, Justin Kopit, Patricia Mendez, Misti Linaberry, Eric Hughes, Stephanie Noviello
发表日期
2014/11/1
期刊
The Lancet
卷号
384
期号
9954
页码范围
1597-1605
出版商
Elsevier
简介
Background
An unmet need exists for interferon-free and ribavirin-free treatments for chronic hepatitis C virus (HCV) infection. In this study, we assessed all-oral therapy with daclatasvir (NS5A replication complex inhibitor) plus asunaprevir (NS3 protease inhibitor) in patients with genotype 1b infection, including those with high unmet needs or cirrhosis, or both.
Methods
We did this phase 3, multicohort study (HALLMARK-DUAL) at 116 sites in 18 countries between May 11, 2012, and Oct 9, 2013. Patients were adults with chronic HCV genotype 1b infection who were treatment-naive; previous non-responders to peginterferon alfa plus ribavirin; or medically ineligible for, previously intolerant of, or ineligible for and intolerant of peginterferon alfa plus ribavirin. Treatment-naive patients were randomly assigned (2:1 ratio) by an interactive voice-response system with a computer-generated random allocation sequence …
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