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Sofosbuvir Plus Ribavirin for the Treatment of Hepatitis C Virus Genotype 2 in Korea: What's the optimal dosage of ribavirin in real-world setting?
Journal of Digestive Diseases 2018 December 11
AIM: The objectives of this study were to examine the efficacy and safety of sofosbuvir plus ribavirin therapy for the treatment of hepatitis C virus 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 hepatitis C virus genotype 2 infection at four centers in Jeollanam-do. After excluding patients lost to follow-up and those with insufficient data, we retrospectively assessed the data for 194 patients.
RESULTS: Sustained virological response was achieved in 189 patients (intention to treat: 97.4%; per protocol: 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 patients (14.2%). The ribavirin dosage reduction rate increased at a dosage of >15 mg/kg body weight (area under the receiver operating curve: 0.652; P = 0.01; 95% confidence interval: 0.54-0.76). Multivariate analysis showed that an age ≥70 years, liver cirrhosis, and female sex were associated with ribavirin dosage reduction.
CONCLUSIONS: Remarkable outcomes were attained in patients with hepatitis C virus genotype 2 infection treated with sofosbuvir plus ribavirin. Age ≥70 years, liver cirrhosis, and female sex were associated with ribavirin dosage reduction. Thus, sustained virological response can be achieved with <1,000 mg of ribavirin, with an optimal dosage of 15 mg/kg body weight.
METHODS: From May 2016 to March 2017, 199 patients received sofosbuvir plus ribavirin treatment for hepatitis C virus genotype 2 infection at four centers in Jeollanam-do. After excluding patients lost to follow-up and those with insufficient data, we retrospectively assessed the data for 194 patients.
RESULTS: Sustained virological response was achieved in 189 patients (intention to treat: 97.4%; per protocol: 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 patients (14.2%). The ribavirin dosage reduction rate increased at a dosage of >15 mg/kg body weight (area under the receiver operating curve: 0.652; P = 0.01; 95% confidence interval: 0.54-0.76). Multivariate analysis showed that an age ≥70 years, liver cirrhosis, and female sex were associated with ribavirin dosage reduction.
CONCLUSIONS: Remarkable outcomes were attained in patients with hepatitis C virus genotype 2 infection treated with sofosbuvir plus ribavirin. Age ≥70 years, liver cirrhosis, and female sex were associated with ribavirin dosage reduction. Thus, sustained virological response can be achieved with <1,000 mg of ribavirin, with an optimal dosage of 15 mg/kg body weight.
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