Gut Liver. 2020;14(6):775-782.

Real-Life Effectiveness and Safety of Sofosbuvir-Based Therapy in Genotype 2 Chronic Hepatitis C Patients in South Korea, with Emphasis on the Ribavirin Dose.

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제1저자 장은선 · 교신저자 정숙향

PMID 32000468 PMC7667937 DOI 10.5009/gnl19260 IF 4.1 소화기내과

소속 (6)

Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea.
Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.
Department of Internal Medicine, Chonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, Korea.
Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.
Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.

Abstract

BACKGROUND/AIMS Sofosbuvir (SOF)-based therapy has been used in Korean patients with chronic hepatitis C virus (HCV) infection since January 2016. This study aimed to investigate the real-life effectiveness and safety of SOF-based therapy in genotype 2 HCV infection.

METHODS From January to December 2016, 458 genotype 2 HCV-infected patients who received ≥1 dose of SOF-based therapy were consecutively enrolled in seven tertiary hospitals. Sustained virologic response (SVR) rates and safety were determined by intention- to-treat (ITT) and per-protocol (PP) analyses.

RESULTS The mean age of the patients was 61.0 years; 183 (40%) were male, and 13.1% showed a high viral load (>6,000,000 IU/ mL). Among the 378 treatment-naïve patients, the SVR rates were 94.2% (ITT) and 96.7% (PP). Among the 80 treatmentexperienced patients, the SVR rates were 96.3% (ITT) and 98.7% (PP). Patients with a relatively high fibrosis-4 index score (>3.25) had similar SVR rates to those with a relatively low score (p=0.756). A total of 314 patients (68.6%) were treated with a reduced ribavirin dose at the prescriber's discretion, but they showed similar SVR rates to those treated with the weight-based dose (ITT: 95.5% and 92.3%, PP: 97.4% and 96.3%, respectively). Adverse events were observed in 191 patients (41.7%), including 86 (18.8%) with anemia, but only one (0.2%) discontinued antiviral therapy due to nausea.

CONCLUSIONS SOF-based therapy showed high real-life efficacy and tolerability in Korean patients with genotype 2 chronic HCV infection, regardless of previous antiviral treatment experience and fibrosis score. A reduced ribavirin dose can be considered in this patient cohort.

Keywords

ChronicGenotype 2Hepatitis CRibavirinSofosbuvir

Figures

**Fig. 1** Sustained virologic response rates of sofosbuvir-based therapy for Korean patients infected with genotype 2 hepatitis C virus according to their treatment experience and liver disease status. ITT, intention-to-treat; PP, per-protocol; SVR12, sustained virologic response at 12 weeks after end of treatment; GT2, genotype 2; TN NC, treatment-naïve patients with no cirrhosis; TN CC, treatment-naïve patients with compensated cirrhosis; TE NC, treatment-experienced patients with no cirrhosis; TE CC, treatment-experienced patients with compensated cirrhosis; DC, patients with decompensated cirrhosis; LT, liver transplantation recipients.

**Fig. 2** Sustained virologic response rates of sofosbuvir-based therapy for Korean patients infected with genotype 2 hepatitis C virus according to the FIB-4 (A), treatment duration (B), and dose of ribavirin (C, D). ITT, intention-to-treat; PP, per-protocol; SVR12, sustained virologic response at 12 weeks after end of treatment; FIB-4, fibrosis-4 index. *The lower dosage of ribavirin than the weight-based recommendation was defined as the reduced dose; †The weight-based dose of ribavirin was defined as 1,000 mg daily in patients with a body weight of <75 kg and 1,200 mg daily in patients with a body weight of ≥75 kg.

그림 출처: PubMed Central 공개 논문 (PMC7667937)

Conflict of interest statement

CONFLICTS OF INTEREST. No potential conflict of interest relevant to this article was reported.

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