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All‐oral daclatasvir plus asunaprevir for chronic hepatitis C virus (HCV) genotype 1b infection: a sub‐analysis in Asian patients from the HALLMARK DUAL study
Author(s) -
Kao JiaHorng,
Lee YounJae,
Heo Jeong,
Ahn SangHoon,
Lim YoungSuk,
Peng ChengYuan,
Chang TingTsung,
Torbeyns Anne,
Hughes Eric,
Bhore Rafia,
Noviello Stephanie
Publication year - 2016
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.13128
Subject(s) - daclatasvir , medicine , gastroenterology , placebo , post hoc analysis , ribavirin , hepatitis c virus , adverse effect , immunology , virus , pathology , alternative medicine
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. SVR 12 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. SVR 12 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 NS 5A‐Y93H or NS 5A‐L31M/V resistance‐associated variants ( RAV s), seven patients achieved SVR 12. Multivariate regression analysis showed a significant influence of NS 5A RAV s 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 SVR 12. 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.