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

Clin Mol Hepatol. 2017 Mar;23(1):51-56. doi: 10.3350/cmh.2016.0053. Epub 2017 Mar 16.

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.

MeSH terms

  • Adult
  • Aged
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Carbamates
  • Drug Administration Schedule
  • Drug Resistance, Viral
  • Drug Therapy, Combination
  • Exanthema / etiology
  • Female
  • Genotype
  • Hepacivirus / genetics
  • Hepacivirus / metabolism
  • Hepatitis C / drug therapy*
  • Hepatitis C / virology
  • Humans
  • Imidazoles / adverse effects
  • Imidazoles / therapeutic use*
  • Isoquinolines / adverse effects
  • Isoquinolines / therapeutic use*
  • Male
  • Middle Aged
  • Pyrrolidines
  • RNA, Viral / blood
  • Republic of Korea
  • Retrospective Studies
  • Sulfonamides / adverse effects
  • Sulfonamides / therapeutic use*
  • Treatment Outcome
  • Valine / analogs & derivatives
  • Viral Nonstructural Proteins / metabolism

Substances

  • Antiviral Agents
  • Carbamates
  • Imidazoles
  • Isoquinolines
  • Pyrrolidines
  • RNA, Viral
  • Sulfonamides
  • Viral Nonstructural Proteins
  • Valine
  • daclatasvir
  • asunaprevir