The effectiveness and safety of sofosbuvir‐ledipasvir for patients with hepatitis C virus genotype 2 infection

Abstract

AbstractSofosbuvir‐ledipasvir (SOF/LDV) had been proved to achieve high sustained virologic response (SVR) rate for patients with hepatitis C virus (HCV) genotype 1 infection. As for patients with HCV genotype 2 (HCV‐2) infection, SOF combined with weight‐based ribavirin was recommended based on earlier guidelines. In Asia‐Pacific region, the pooled analysis of three clinical studies in Taiwan, Japan, and New Zeeland, respectively, revealed that the SVR12 rate of SOF/LDV for with HCV‐2 infected patients without decompensated cirrhosis could be higher than 95%. Based on these results, SOF/LDV had been reimbursed for treating patients with HCV‐2 infection since Oct 2018 in Taiwan. The aim of our study is to evaluate the effectiveness and safety of SOF/LDV for HCV‐2 infected patients. A total of 298 HCV‐2 infected patients without decompensated cirrhosis who received SOF/LDV for 12 weeks in Chia‐Yi Christian Hospital between January 2019 and December 2019 were retrospectively enrolled in this study. The effectiveness was defined as SVR at 12 weeks off treatment (SVR12). The SVR12 rates of different categorical patients were also assessed. Adverse effects, laboratory abnormalities, and evolution of estimated glomerular filtration rate (eGFR) were evaluated. The SVR12 rate of SOF/LDV for 12 weeks in HCV‐2 infected patient without decompensated cirrhosis was 98.3% (293/298, 95% CI: 96.1%‐99.3%) and 99.3% (293/295, 95% CI: 97.6%‐99.8%) in intention‐to‐treat and per‐protocol analysis, respectively. None had premature discontinuity of drugs induced by serious adverse effect in our study. The worsening of eGFR from baseline to 12 weeks off treatment was found in CKD‐staged 1 patients with a quadratic trend. SOF in combination with ledipasvir (SOF/LDV) for 12 weeks could provide good SVR12 rate with good tolerability for HCV‐2 infected patients without decompensated cirrhosis.