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

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

• Cho BW
• Kim SB
• Song IH
• Lee SH
• Kim HS
• Lee TH
• Kang YW
• Kim SH
• Lee BS
• Chae HB

• KMID: 2412114
• DOI: http://doi.org/10.3350/cmh.2016.0053

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.

Keyword

Daclatasvir; Asunaprevir; Hepatitis C, Chronic; Korea

MeSH Terms

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