Sofosbuvir-based therapy for patients with chronic hepatitis C: Early experience of its efficacy and safety in Korea.
10.3350/cmh.2015.21.4.358
- Author:
Yuri CHO
1
;
Eun Ju CHO
;
Jeong Hoon LEE
;
Su Jong YU
;
Jung Hwan YOON
;
Yoon Jun KIM
Author Information
1. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea. yoonjun@snu.ac.kr
- Publication Type:Original Article
- Keywords:
Chronic hepatitis C;
Direct-acting antiviral;
Korea
- MeSH:
Adult;
Aged;
Aged, 80 and over;
Antiviral Agents/adverse effects/*therapeutic use;
Drug Therapy, Combination;
Fatigue/etiology;
Female;
Genotype;
Headache/etiology;
Hemoglobins/analysis;
Hepacivirus/genetics;
Hepatitis C, Chronic/complications/*drug therapy/virology;
Humans;
Liver Cirrhosis/complications/diagnosis;
Male;
Middle Aged;
RNA, Viral/blood;
Republic of Korea;
Retrospective Studies;
Ribavirin/therapeutic use;
Sofosbuvir/adverse effects/*therapeutic use;
Treatment Outcome
- From:Clinical and Molecular Hepatology
2015;21(4):358-364
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND/AIMS: The previous standard treatment for chronic hepatitis C (CHC) patients, comprising a combination of pegylated interferon (IFN) and ribavirin, was associated with suboptimal efficacy and severe adverse reactions. A new era of direct-acting antivirals is now dawning in Korea. Early experience of applying sofosbuvir-based therapy to CHC patients in Korea is reported herein. METHODS: Data on efficacy and safety were collected for CHC patients treated with a combination of sofosbuvir plus ribavirin or sofosbuvir/ledipasvir with or without ribavirin. RESULTS: This retrospective study included 25 consecutive patients who received sofosbuvir-based therapy (19 with genotype 1b and 6 with genotype 2) at Seoul National University Hospital from May 2014 to April 2015. A virologic response was achieved at week 4 by 85.7% and 80% of the patients with genotypes 1b and 2, respectively. The HCV-RNA level decreased more slowly in IFN-experienced than in treatment-naive patients with genotype 1b. However, the sustained virologic response at week 12 (SVR12) rate did not differ among these patients, and was as high as 100%. The presence of cirrhosis significantly increased the risk of a virologic response failure at week 4 (OR, 11.0; P=0.011) among patients with HCV genotype 1b. Only five patients (20%) experienced minor adverse events, including grade 1 fatigue and headache. The hemoglobin level decreased slightly after sofosbuvir-based therapy, but there was no case of premature discontinuation of this therapy. CONCLUSIONS: In a real clinical practice, sofosbuvir-based therapy for CHC patients in Korea achieved optimal antiviral efficacy with insignificant adverse events. Long-term follow-up data are warranted to ensure the sustained antiviral efficacy and long-term safety of sofosbuvir-based IFN-free therapy.
