A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin.

Abstract Daclatasvirplus asunaprevirhas demonstrated efficacy and safety in patients with chronic hepatitis C virus genotype1b infection. This study focused on evaluating daclatasvirplus asunaprevirin interferon (± ribavirin)-ineligible or -intolerant Asian patients with genotype 1b infection from mainland China, Korea, and Taiwan. Interferon (± ribavirin)-ineligible and -intolerant patients with genotype 1b infection received daclatasvir60 mg tablets once-daily plus asunaprevir100 mg soft capsules twice-daily for 24 weeks. The primary endpoint was sustained virologic response at post-treatment Week 24 (SVR24). Of the 159 patients treated, 89.3% were Chinese, 65.4% were female, and 73.6% were interferon-intolerant. Cirrhosis was present in 32.7% of patients and 40.3% had IL28B non-CC genotypes. SVR24 was achieved by 145/159 (91.2%) patients (100% concordance with SVR12) and was similarly high in cirrhotic patients (47/52, 90.4%). SVR24 was higher in patients without baseline NS5A(L31M or Y93H) resistance-associated variants (RAVs) (137/139, 98.6%), including those with cirrhosis (43/44, 97.7%). Prevalence of baseline NS5ARAVs was low (19/159, 11.9%), particularly in mainland China(10/127, 7.9%). One death (0.6%), five serious adverse events (3.1%), and three grade 4 laboratory abnormalities (1.9%) occurred on-treatment; none were considered related to study drugs. Two patients (1.3%) discontinued due to adverse events. Treatment was generally well-tolerated regardless of cirrhosis status. Daclatasvirplus asunaprevirachieved a SVR24 rate of 91.2%, rising to 98.6% in patients without baseline NS5ARAVs, and was generally well tolerated in interferon (± ribavirin)-ineligible or -intolerant patients with genotype 1b infection from mainland China, Korea, and Taiwan. This article is protected by copyright. All rights reserved.