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SOF/VEL/VOX with, without RBV effective in DAA-experienced HCV patients

Fixed dose treatment with sofosbuvir-velpatasvir-voxilaprevir with or without ribavirin for 12 weeks was effective and well-tolerated in patients with hepatitis C genotype 1 who had previously failed direct-acting antiviral therapy, according to a recent study.

“The addition of ribavirin ... has been shown to improve rates of [sustained virologic response] in response to treatment with a number of regimens, including sofosbuvir-velpatasvir for patients with decompensated cirrhosis,” the researchers wrote. “It appears that the combination of [these] three highly potent DAAs can obviate the need for [ribavirin] to be included in a regimen to maximize efficacy.”

Between July 2015 and June 2016, the researchers conducted the phase 2, open-label study comprising 49 patients. Researchers randomly divided patients into one group of 25 who received sofosbuvir-velpatasvir-voxilaprevir (SOF/VEL/VOX; Gilead) with ribavirin and 24 who received treatment without ribavirin.

Most patients were younger than 65 years (90%), white (80%), men (65%), had cirrhosis at baseline (51%) and had been treated for HCV only once prior to this study (88%). Thirty-five patients had resistant-associated substitution (RAS), among whom 15% had NS5A RASs only, 31% with NS3 RASs only and 27% with multiple class RASs.

Twenty-four of the 25 patients who received SOF/VEL/VOX with ribavirin and all the patients who received SOF/VEL/VOX alone achieved SVR at 12 weeks. The patient who did not achieve SVR had RAS at baseline.

The most common adverse events attributed to SOF/VEL/VOX included diarrhea (13%) and bronchitis (8%), occurring in 11 patients receiving the treatment alone, and fatigue (36%), anemia (16%), gastroenteritis (8%) and nausea (8%), occurring in 15 patients receiving ribavirin. While there were no discontinuations from SOF/VEL/VOX treatment due to adverse events, three patients discontinued ribavirin due to anemia, fatigue or rash.

“This study is limited by its relatively small sample size, lack of enrollment of Asian patients, and open-label design,” the researchers wrote. “In four subsequent phase 3 registrational trials, patients of all genotypes and treatment histories were enrolled in blinded and open-label studies, in which treatment was similarly well-tolerated and efficacious.” – by Talitha Bennett

Disclosure: Lawitz reports consulting for, advising for, is on the speakers bureau for and received grants from AbbVie, Bristol-Myers Squibb, Gilead, Janssen and Merck; he consults for, advises for and received grants from Achillion, Santaris and Theravance; he consults for and advises for Novartis and Regulus; he received grants from Boehringer Ingelheim, Enanta, Roche, Salix and Tacere. Please see the full study for the other researchers’ relevant financial disclosures.