Sofosbuvir–velpatasvir combo for HCV yields high SVR rate even in absence of ribavirin
In patients with genotype 3 hepatitis C virus (HCV) infection and decompensated cirrhosis, the rate of achieving sustained virologic response 12 weeks after treatment (SVR12) is high with treatment regimens consisting of sofosbuvir and velpatasvir with or without ribavirin, according to the results of a phase II trial. However, the rate appears to be lower in the subgroup of patients with baseline resistance-associated substitutions (RASs) in nonstructural protein 5A (NS5A).
The study randomized 204 patients with genotype 3 HCV infection and compensated cirrhosis (mean age 51 years; 79 percent male) to groups given sofosbuvir and velpatasvir for 12 weeks with (n=103) or without (n=101) ribavirin. Overall SVR12 rates were 91 percent with sofosbuvir–velpatasvir and 96 percent with the addition of ribavirin.
In the sofosbuvir–velpatasvir group, SVR12 rates were lower in the subgroup of patients with vs without baseline NS5A RASs (84 percent vs 96 percent). On the other hand, baseline RASs had less effect on SVR12 in the sofosbuvir–velpatasvir plus ribavirin group (96 percent vs 99 percent, respectively).
The treatment regimens were well tolerated. The most common adverse events (occurring in ≥10 percent of patients overall) were asthenia (12 percent) in the sofosbuvir–velpatasvir group, and asthenia (27 percent), headache (24 percent) and insomnia (12 percent) in the sofosbuvir–velpatasvir plus ribavirin group. Serious adverse events were rare.
The present data support the use of sofosbuvir–velpatasvir with or without ribavirin in the treatment of patients with genotype 3 HCV infection and cirrhosis. Researchers pointed out that its impact on clinical practice may be influenced by the cost and availability of resistance testing, treatment with ribavirin, and potential retreatment of virologic failures with salvage regimens.
The study was limited by the lack of formal statistical comparison between treatment groups. Researchers explained such a comparison would not have been practically feasible given the interest in generating data in a timely fashion and the limited number of patients within the subpopulation.