Patients with chronic hepatitis C virus-genotype-4 (HCV-GT4) in countries with limited resources may have a new treatment option with the combination of ravidasvir (an NS5A inhibitor) plus sofosbuvir, with or without ribavirin, according to a phase 3 study published in the Journal of Hepatology.
In one of the largest studies of interferon-free direct-acting antiviral treatment conducted in patients with HCV-GT4, 300 patients were randomly assigned to one of three groups according to their previous use of interferon and whether they had cirrhosis. Two of the groups received ravidasvir 200 mg daily plus sofosbuvir 400 mg daily and were randomly assigned 1:1 to treatment with or without weight-based ribavirin for 12 weeks. The third group received ravidasvir plus sofosbuvir with ribavirin and were randomly assigned 1:1 to a treatment duration of 12 weeks or 16 weeks.
Overall, 95.3% of patients achieved the primary end point of sustained virologic response at 12 weeks posttreatment, including 98% of patients without cirrhosis and 91% of patients with cirrhosis, regardless of their history of interferon treatment. Concomitant treatment with ribavirin and previous interferon use did not affect the response rates.
Combination treatment with ravidasvir and sofosbuvir was well tolerated, and most adverse events were mild and similar to those of other direct antiviral combination therapies.
This was the first clinical trial evaluating the combination of ravidasvir plus sofosbuvir, with or without ribavirin, and the authors concluded that “RDV plus SOF is a promising new once-daily oral treatment that was well tolerated in a large group of HCV-G4 patients, with high rates of sustained virologic response in patients with and without cirrhosis.”
Esmat G, Elbaz T, El Raziky M, et al. Effectiveness of ravidasvir plus sofosbuvir in interferon-naïve and treated patients with chronic hepatitis c genotype-4 [published online September 18, 2017]. J Hepatol. doi: 10.1016/j.jhep.2017.09.006&.