Gilead Submits New Drug Application for Pan-Genotypic Hepatitis C Drug

Gilead recently announced they have submitted a new drug application to the FDA for an experimental direct-acting antiviral tablet for the treatment of hepatitis C virus (HCV).

The once-daily tablet contains sofosbuvir 400-mg, velpatasvir 100-mg, and voxilaprevir 100-mg (SOF/VEL/VOX), according to a press release from Gilead.

The manufacturer is seeking approval of the combination for the treatment of patients with HCV genotypes 1 through 6 who failed prior treatment with other direct-acting antivirals, including regimens that contain NS5A inhibitors.

The new drug application included data that supports the drug’s use in these patients, and in those with or without cirrhosis, Gilead reported. Supporting data from multiple phase 3 studies were included in the submission.

In the phase 3 studies POLARIS-1 and POLARIS-4, 445 patients with HCV genotypes 1 through 6 received 12 weeks of the fixed-dose combination drug to determine its efficacy, according to Gilead. Approximately 97% of patients who were included achieved the primary efficacy endpoint of the trials, which was SVR12.

Additionally, data from the POLARIS-2 and POLARIS-3 studies were included in the new drug application. There were 611 treatment-naïve patients included who received 9 weeks of SOF/VEL/VOX. Supporting data was also presented at the American Association for the Study of Liver Diseases annual meeting.

Gilead reported that common adverse events experienced by these patients include headache, fatigue, diarrhea, and nausea. The drug’s safety and efficacy profile has not been established, according to the press release.

SOF/VEL/VOX previously received Breakthrough Therapy designation from the FDA for the treatment of patients with HCV genotype 1 who previously failed to respond to treatment with an NS5A inhibitor.

If the FDA approves the drug, it will be the first and only once-daily single tablet treatment for patients with HCV genotypes 1 through 6 who failed treatment with other direct-acting antivirals, according to Gilead.

“The remaining clinical need to treat HCV patients is a safe and effective cure for patients who have failed previous therapy with DAA regimens, including those with NS5A inhibitors,” said Norbert Bischofberger, PhD, executive vice president of Research and Development and chief scientific officer at Gilead. “SOF/VEL/VOX has the potential to fill that need by offering single tablet dosing and high cure rates across all HCV genotypes for patients with and without cirrhosis, who have failed prior treatment with other highly effective regimens.”