Jae Hyun Yoon1, Chung Hwan Jun1, Ji Ho Seo1, Hyun A Cho1, Sung Bum Cho2, Sung Kyu Choi1, Ju Yeon Cho3, Man Woo Kim3, Sung Wook Lim4. 1. Department of Gastroenterology, Chonnam National University Hospital and Medical School, Gwangju, South Korea. 2. Department of Gastroenterology, Hwasun Chonnam National University Hospital and Medical School, Hwasun, South Korea. 3. Department of Internal Medicine, School of Medicine, Chosun University, Gwangju, South Korea. 4. Department of Internal Medicine, Mokpo Hankook Hospital, Mokpo, South Korea.
Abstract
OBJECTIVE: This study aimed to investigate the efficacy and safety of sofosbuvir plus ribavirin for the treatment of hepatitis C virus (HCV) genotype 2 infection and to determine the optimal ribavirin dosage. METHODS: From May 2016 to March 2017, 199 patients received sofosbuvir plus ribavirin treatment for HCV genotype 2 infection at four centers in Jeollanam-do Province, Korea. After excluding patients lost to follow-up and those with insufficient data, we retrospectively assessed the data for 194 patients. The treatment efficacy and safety of sofosbuvir plus ribavirin were evaluated. RESULTS: A sustained virological response was achieved in 189 patients (intention-to-treat [ITT] 97.4%; per protocol [PP]: 99.5%, both at 12 and 24 weeks) whose average ribavirin dosage was 937.1 mg/day. The most frequent adverse event was anemia (17.5%), and its incidence significantly increased (P < 0.001) with a higher ribavirin dosage per body weight. Discontinuation of ribavirin or dosage reduction occurred in 27 (14.2%). The ribavirin dosage reduction rate increased at a dosage of >15 mg/kg (area under the receiver operating characteristic curve 0.652, 95% confidence interval [CI] 0.54-0.76, P = 0.01). Multivariate analysis showed that age ≥70 years, with liver cirrhosis, and female gender were associated with ribavirin dosage reduction. CONCLUSIONS: Remarkable outcomes were attained in patients with HCV genotype 2 infection treated with sofosbuvir plus ribavirin. Age ≥70 years, with liver cirrhosis, and female gender were associated with ribavirin dosage reduction. Thus, sustained virological response can be achieved with <1000 mg of ribavirin, with an optimal dosage of 15 mg/kg.
OBJECTIVE: This study aimed to investigate the efficacy and safety of sofosbuvir plus ribavirin for the treatment of hepatitis C virus (HCV) genotype 2 infection and to determine the optimal ribavirin dosage. METHODS: From May 2016 to March 2017, 199 patients received sofosbuvir plus ribavirin treatment for HCV genotype 2 infection at four centers in Jeollanam-do Province, Korea. After excluding patients lost to follow-up and those with insufficient data, we retrospectively assessed the data for 194 patients. The treatment efficacy and safety of sofosbuvir plus ribavirin were evaluated. RESULTS: A sustained virological response was achieved in 189 patients (intention-to-treat [ITT] 97.4%; per protocol [PP]: 99.5%, both at 12 and 24 weeks) whose average ribavirin dosage was 937.1 mg/day. The most frequent adverse event was anemia (17.5%), and its incidence significantly increased (P < 0.001) with a higher ribavirin dosage per body weight. Discontinuation of ribavirin or dosage reduction occurred in 27 (14.2%). The ribavirin dosage reduction rate increased at a dosage of >15 mg/kg (area under the receiver operating characteristic curve 0.652, 95% confidence interval [CI] 0.54-0.76, P = 0.01). Multivariate analysis showed that age ≥70 years, with liver cirrhosis, and female gender were associated with ribavirin dosage reduction. CONCLUSIONS: Remarkable outcomes were attained in patients with HCV genotype 2 infection treated with sofosbuvir plus ribavirin. Age ≥70 years, with liver cirrhosis, and female gender were associated with ribavirin dosage reduction. Thus, sustained virological response can be achieved with <1000 mg of ribavirin, with an optimal dosage of 15 mg/kg.