European Medicines Agency Validates Gilead's HCV Combination Therapy

The European Medicines Agency has fully validated Gilead’s Marketing Authorization Application (MAA) for their investigational, once-daily, single tablet regimen of sofosbuvir/velpatasvir/voxilaprevir for the treatment of hepatitis C virus (HCV), and the combination is now under assessment.

The MAA for SOF/VEL/VOX is based on data from the phase 3 studies POLARIS-1 and POLARIS-4, according to a Gilead press release. The studies evaluated 12 weeks of the fixed-dose combination therapy in direct-active antiviral (DAA)-experienced patients with HCV genotypes 1 to 6, including those who failed prior treatment with an NS5A inhibitor-contain regimen.

Across the 2 studies, 97% of patients treated with SOF/VEL/VOX achieved the primary efficacy endpoint of SVR12, the press release reported.

The MAA also included data from 2 additional phase 3 studies, POLARIS-2 and POLARIS-3. These studies evaluated 8 weeks of SOF/VEL/VOX in 611 DAA-naïve patients with HCV genotypes 1 to 6.

The results of the POLARIS-3 study showed that 96% of patients with genotype 3 infection and cirrhosis treated with the regimen achieved the primary efficacy endpoint of SVR 12.

The most common adverse events among patients administered SOF/VEL/VOX were headache, fatigue, diarrhea, and nausea, according to the company release.

“Direct-acting antiviral treatments have transformed our ability to treat hepatitis C; however, for some patients who have failed to achieve a cure with these regimens, effective and well-tolerated therapies are still needed,” said Norbert Bischofberger, PhD, executive vice president of research and development, and chief scientific officer at Gilead. “The submission of this application reflects our continued commitment to provide treatment options for this life-threatening disease to as many patients as possible, including those who have failed previous direct-active antiviral therapy, in Europe and around the world.”

SOF/VEL/VOX for the treatment of HCV will be review by the EMA under the centralized licensing procedure for all 28 member states of the European Union, Norway, and Iceland.