Efficacy and safety of daclatasvir plus asunaprevir for Korean patients with HCV genotype Ib infection: a retrospective multi-institutional study

Abstract

Background/aims: The combination of daclatasvir (DCV) and asunaprevir (ASV) has demonstrated a high sustained virologic response at 12 weeks (SVR12) and a low rate of adverse events in previous clinical studies. The purpose of this study was to clarify the results of treatment and side effects in Korean patients with chronic hepatitis C virus (HCV) genotype Ib infection.

Methods: We retrospectively analyzed clinical data from chronic HCV genotype Ib patients treated with DCV+ASV from August 2015 to September 2016 at five hospitals in the Daejeon-Chungcheong area.

Results: A total of 152 patients were examined for resistance associated variants (RAVs). Among them, 15 (9.9%) were positive for Y93 and one (0.7%) was positive for L31. Of 126 patients treated with DCV+ASV, 83 patients completed treatment and 76 patients were included in safety and efficacy analysis. Five (6.6%) were positive for Y93 and 12 (15.8%) exhibited cirrhotic change. DCV+ASV was the first-line treatment for 58 (76.3%) patients. Eleven (14.5%) patients relapsed after previous treatment that included interferon and seven (9.2%) of these patients were found to be intolerant of interferon. Adverse events occurred in 10 (13.2%) patients and two patients stopped the medication because of severe itching and skin rash. SVR12 was 89.5% (68/76) in all patients and 91.5% (65/71) in RAV-negative patients.

Conclusions: DCV+ASV showed good efficacy in patients with HCV Ib infection in Korea. Close monitoring is needed for severe adverse events and treatment failure, which were uncommon.

Keywords: Asunaprevir; Daclatasvir; Hepatitis C, Chronic; Korea.

Figure 1.

Flow chart summarizing patient selection. HCV, hepatitis C virus; NS5A, non-structural 5A; RAV, resistance-associated variant; DCV, daclatasvir; ASV, asunaprevir.

Figure 2.

SVR12 overall and by prior treatment status in patients treated with DCV+ASV analyzed according to the presence of RAV. SVR12 was higher in RAV(-) patients than in RAV(+) patients. DCV, daclatasvir; ASV, asunaprevir; RAV, resistance-associated variant; SVR12, sustained virologic response 12 weeks post-treatment.

Figure 3.

SVR12 according to baseline age, sex, presence of cirrhosis, Child-Pugh score, and pretreatment HCV RNA level. There was a higher SVR12 tendency in those who were male, younger than 60 years, without cirrhosis, and with an HCV RNA level ≥6 log10 IU/mL, but these findings were not statistically significant. HCV, hepatitis C virus; SVR12, sustained virologic response 12 weeks post-treatment.