Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single‐arm, open‐label, phase 3 trial
Liver International Oct 16, 2020
Gao Y, Kong F, Li G, et al. - The effectiveness and safety of coblopasvir (a pangenotypic non‐structural protein 5A inhibitor) in combination with sofosbuvir for treating Chinese patients with chronic hepatitis C virus (HCV) infection was assessed in this single‐arm, open‐label, multicenter, phase 3 trial. Once daily, for 12 weeks, researchers treated treatment‐naïve and interferon‐experienced adult patients, including those with advanced fibrosis (F3) or compensated cirrhosis (F4), with a universal, combinational regimen of coblopasvir 60 mg and sofosbuvir 400 mg. Sustained virological response at post‐treatment week 12 was the primary efficacy outcome. This analysis included a total of 371 patients (men, 51%; age, 47 ± 11 years; genotype 1a = < 1%, 1b = 48%, 2a = 26%, 3a = 6%, 3b = 7% and 6 =12%) from 19 sites. It was shown that universal, pan-genotypic combo of coblopasvir plus sofosbuvir was found to be an effective and safe treatment for Chinese individuals monoinfected with HCV of genotype 1, 2, 3, and 6, including those with compensated cirrhosis. For the full analysis set, the overall SVR12 was 97%; it was equal to or above 90% for all predefined subsets. Most AEs were mild to moderate and transient and did not need specific medical intervention.
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