Background & Aims: Daclatasvir plus asunaprevir (DCV + ASV) has demonstrated potent antiviral activity in patients with hepatitis C virus (HCV) genotype 1b (GT-1b) infection in the HALLMARK DUAL trial. This post hoc analysis was conducted to determine the efficacy and safety of this treatment in Asian patients. Methods: Treatment-naive patients were randomly assigned (2:1; double-blinded) to receive DCV (60 mg once daily) plus ASV (100 mg twice daily) or placebo for 12 weeks. Subsequently, placebo patients entered another study, and the remaining patients continued treatment for an additional 12 weeks. Non-responders to peginterferon/ribavirin and ineligible/intolerant patients received dual therapy for 24 weeks. Sustained virological response at post-treatment Week 12 [sustained virological response (SVR)12] and safety outcomes were evaluated. Results: This post hoc analysis included 186 Asian patients (Korean, 78; Taiwanese, 85; others, 23), of whom 32.3% were cirrhotic. SVR12 was observed in 92.3, 78.6 and 80.0% of treatment-naive, ineligible/intolerant and non-responder patients, respectively, and was comparable with non-Asian patients. SVR12 by baseline factors including age, viral load, interleukin-28B genotype and cirrhosis status was similar between the Asian sub-cohorts. Among 18 Asian patients with NS5A-Y93H or NS5A-L31M/V resistance-associated variants (RAVs), seven patients achieved SVR12. Multivariate regression analysis showed a significant influence of NS5A RAVs in both Asian and non-Asian cohorts. The incidence of serious adverse events in Asian patients was low (7.2%). Two Taiwanese patients had elevated alanine aminotransferase (≥5.1 × ULN); both achieved SVR12. Conclusions: All-oral dual therapy with DCV + ASV resulted in high SVR rates and was well tolerated in Asian patients with HCV GT-1b infection.
Bibliographical noteFunding Information:
The authors and the sponsor thank all study patients and research staff for their participation in this study. Editorial assistance with the preparation of this manuscript was provided by MediTech Media Asia Pacific and was funded by Bristol-Myers Squibb, Korea. Results of this sub-analysis were previously presented at the 24th Conference of the Asia Pacific Association for the Study of the Liver held in Istanbul, Turkey from 12 to 15 March 2015. Financial support: This study was sponsored by Bristol-Myers Squibb. Conflict of interest: Cheng-Yuan Peng has served as an advisory committee member for AbbVie, Bristol-Myers Squibb, Gilead, Merck Sharp & Dohme and Roche. Anne Torbeyns, Eric Hughes and Rafia Bhore are employees of Bristol-Myers Squibb. Stephanie Noviello is an employee and stock holder of Bristol-Myers Squibb.
© 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
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