Clin Mol Hepatol.  2015 Dec;21(4):358-364. 10.3350/cmh.2015.21.4.358.

Sofosbuvir-based therapy for patients with chronic hepatitis C: Early experience of its efficacy and safety in Korea

• Cho Y
• Cho EJ
• Lee JH
• Yu SJ
• Yoon JH
• Kim YJ

• KMID: 2359817
• DOI: http://doi.org/10.3350/cmh.2015.21.4.358

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.

Keyword

Chronic hepatitis C; Direct-acting antiviral; Korea

MeSH Terms

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
Antiviral Agents
Hemoglobins
RNA, Viral
Ribavirin
Sofosbuvir