Sofosbuvir-velpatasvir administered for 12 weeks is efficacious and safe for patients of Asian race with chronic hepatitis C (HCV) infection, although efficacy may be reduced in those infected with HCV genotype 3b and with cirrhosis, according to findings published in Lancet Gastroenterology & Hepatology.
The safety and efficacy of the fixed-dose combination of sofosbuvir-velpatasvir given for 12 weeks has been established in several phase 3 clinical trials. However, there are distinct genotypic distributions across countries and regions, and no prospective, large-scale studies of sofosbuvir-velpatasvir have been conducted in Asia. Researchers thus conducted a single-group, phase 3 trial composed of 375 patients from China, Malaysia, Thailand, Vietnam, and Singapore who have chronic infection with HCV genotypes 1 to 6, with or without compensated cirrhosis. The primary efficacy endpoint was sustained virologic response, defined as HCV RNA ≤15 IU/mL at week 12 post-treatment, and the safety endpoint was the proportion of adverse events leading to early treatment discontinuation.
Patients received a combined sofosbuvir (400 mg) and velpatasvir (100 mg) tablet once daily for 12 weeks, and 374 completed the full protocol. The majority (n=362, 97%) of all participants achieved sustained virologic response at 12 weeks post-treatment. Forty-two of 84 patients with HCV genotype 3 had infection with genotype 3b, of whom 32 (95% CI, 61-88) individuals achieved sustained virologic response at 12 weeks post-treatment. Sustained virologic response at week 12 was also seen in 25 of 28 (95% CI, 72-98) patients without cirrhosis and 7 of 14 with cirrhosis (95% CI, 23-77). None of the patients discontinued the treatment because of adverse events.
The study authors reported that because Asia is a “large geographical region that comprises genetically and ethnically diverse populations,” this may limit the generalizability of these findings because study enrollment was limited to 5 selected countries.
Wei L, Lim SG, Xie Q, et al. Sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial. Lancet Gastroenterol Hepatol. 2018;4(2):127-134.