Gilead Submits New Drug Application for Once-daily Single Tablet Regimen for HCV

Gilead Submits New Drug Application for Once-daily Single Tablet Regimen for HCV

Gilead Sciences submitted a regulatory new drug application (NDA) for its investigational, once-daily single tablet regimen of SOF/VEL/VOX (sofosbuvir, velpatasvir, and voxilaprevir) for the treatment of hepatitis C infection with the viral genotypes 1 to 6.

The NDA submitted to the U.S. Food and Drug Administration (FDA) is for the fixed dose of SOF/VEL/VOX at 400 mg, 100 mg, and 100 mg, respectively. If approved, the regimen would be the first salvage therapy for patients infected with hepatitis C virus (HCV) genotypes 1-6 who have failed prior treatment with direct-acting antiviral (DAA) regimens, including NS5A inhibitors (NS5A is part of the viral genome and is important for viral replication).

The data behind the submission was presented at the American Association for the Study of Liver Diseases Annual Meeting (AASLD 2016) in November.

“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,” Norbert Bischofberger, PhD, Gilead’s executive vice president of research and development and chief scientific officer, said in a press release.

“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,” he said.

The FDA granted Breakthrough Therapy designation to SOF/VEL/VOX regimen for the treatment of chronic genotype 1 HCV patients who have previously failed a treatment regimen with a NS5A inhibitor.

This newly submitted NDA is based on data from two Phase 3 clinical studies, POLARIS-1 (NCT02607735) and POLARIS-4 (NCT02639247), which evaluated a fixed dose of SOF/VEL/VOX for 12 weeks in the same group of DAA-experienced patients with HCV genotypes 1-6.

Of the 445 patients enrolled in these trials, 430 (97%) achieved the primary effectiveness endpoint — a sustained virologic response (SVR) 12 weeks after the treatment was discontinued.

The NDA is further supported by positive results from two additional Phase 3 studies, POLARIS-2 (NCT02607800) and POLARIS-3 (NCT02639338), in which 611 participants who had not been treated with DAA received the combination treatment for eight weeks. The most common adverse events observed were headaches, fatigue, diarrhea, and nausea.


In other news, Gilead Sciences Canada was recently awarded this year’s Prix Galien Canada – Innovative Product Award for the development of Harvoni (ledipasvir/sofosbuvir), a combination treatment for chronic genotype 1 HCV in adults.

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