High Sustained Virologic Response to Daclatasvir Plus Asunaprevir in Elderly and Cirrhotic Patients with Hepatitis C Virus Genotype 1b Without Baseline NS5A Polymorphisms

• DOI: 10.1007/s12325-015-0221-5
• Publication Date: 2015-07-08T11:51:25Z
• Authors: Fiona McPhee; Yoshiyuki Suzuki; Joji Toyota; Yoshiyasu Karino; Kasuaki Chayama; Yoshiiku Kawakami; Min Lung Yu; Sang Hoon Ahn; Hiroki Ishikawa; Rafia Bhore; Nannan Zhou; Dennis Hernandez; Patricia Mendez; Hiromitsu Kumada
• Keywords: Daclatasvir; NS5A; Sofosbuvir; Hepatitis C; NS3

Oral daclatasvir (DCV; pangenotypic NS5A inhibitor) plus asunaprevir (ASV; NS3 protease is approved in Japan and Korea for treatment of chronic hepatitis C virus (HCV) genotype 1. Response to DCV + ASV affected by resistance-associated polymorphisms (RAPs) HCV NS5A. The prevalence influence these RAPs on 12-week sustained virologic response (SVR12) was evaluated Asian non-Asian patients. Data were pooled from 5 national international studies patients with 1b (GT-1b) receiving at their recommended doses. Baseline effect SVR12 assessed overall, older (≥65 years) patients, cirrhosis, stratified baseline RNA or prior experience interferon-based therapy. sequences available 988 (374 Japanese; 125 Korean/Taiwanese; 489 countries), 979 whom SVR12. Pretreatment NS5A-L31F/I/M/V and/or NS5A-Y93H present 18% Japanese 12–13% non-Japanese patients; reduced 54.9% overall (93.9% [787/838] when absent, 39.0% [55/141] present), comparable reductions observed Asians non-Asians across all categories experience, age, cirrhosis. RAP-associated rates declined increasing (SVR12 RAPs: 64.7% [11/17] 5-6 log10 IU/mL, 29.8% [14/47] 7–8 log10). Without RAPs, very high (92–100%) cirrhosis irrespective origin, similarly among treatment-naïve interferon-experienced those RNA. Following treatment, the GT-1b without (approximately 90–100%), interferon Bristol-Myers Squibb.