3-Drug Regimen May Be Effective for Nonresponsive HCV Patients

The combination of voxilaprevir, velpatasvir, and sofosbuvir effectively treated patients with hepatitis C (HCV) who did not respond to direct-acting antiviral agents (DAAs), according to a recent study.

The researchers conducted 2 phase 3 trials that included patients with HCV who had previously been treated with a DAA-containing regimen.
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POLARIS-1 was a randomized placebo controlled trial that included 150 patients who received the protease inhibitor voxilaprevir and 150 patients who received placebo. All participants took either voxilaprevir or placebo once a day with both sofosbuvir and velpatasvir for 12 weeks.

POLARIS-4 was a randomized trial that included 163 patients randomly assigned to receive sofosbuvir, velpatasvir, and voxilaprevir for 12 weeks, and 151 patients randomly assigned to receive sofosbuvir and velpatasvir for 12 weeks.

Compensated cirrhosis occurred in 46% of patients who were in the active-treatment groups. Participants in POLARIS-1 who were assigned to receive voxilaprevir had a sustained virologic response rate of 96% compared with a response rate of 0% among patients who received the placebo.

Likewise, patients who received voxilaprevir in POLARIS-4 had a response rate of 98% compared with a response rate of 90% among patients who did not receive voxilaprevir.

The most common adverse events reported by participants were headache, nausea, fatigue, and diarrhea. Adverse events resulted in discontinued therapy among 1% or lower of patients in both trials in the active treatment groups.

“Sofosbuvir–velpatasvir–voxilaprevir taken for 12 weeks provided high rates of sustained virologic response among patients across HCV genotypes in whom treatment with a DAA regimen had previously failed,” the researchers concluded.

—Melissa Weiss

Reference:

Bourlière M, Gordon SC, Flamm SL, et al. Sofosbuvir, velpatasvir, and voxilaprevir for previously treated HCV infection [published online June 1, 2017]. N Engl J Med. doi:10.1056/NEJMoa1613512.