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Gilead Submits NDA for Investigational Treatment of HCV

Gilead Sciences today filed a New Drug Application with the FDA for an investigational fixed-dose hepatitis C virus treatment.

The NDA is for a once-daily single tablet regimen containing 400 mg of sofosbuvir (Sovaldi, Gilead) and 100 mg each of velpatasvir and voxilaprevir (sof/vel/vox).

It would be the first once-daily single tablet regimen available as a salvage therapy for patients with HVC genotypes 1 through 6 infection who have failed prior treatment with direct-acting antiviral regimens including NS5A inhibitors, Gilead announced in a news release.

The data submitted in the NDA are from the phase 3 POLARIS-1 and POLARIS-4 studies and support the use of the regimen for 12 weeks in such patients without cirrhosis or with compensated cirrhosis, the company said.

Norbert Bischofberger, PhD
Norbert Bischofberger

“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, executive vice president of research and development and chief scientific officer at Gilead, said in the 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.”

The sof/vel/vox fixed-dose combination was previously granted breakthrough therapy designation by the FDA for the treatment of patients with chronic HCV genotype 1 who previously failed an NS5A inhibitor-containing regimen.

Disclosures: Bischofberger works for Gilead.

Gilead Sciences today filed a New Drug Application with the FDA for an investigational fixed-dose hepatitis C virus treatment.

The NDA is for a once-daily single tablet regimen containing 400 mg of sofosbuvir (Sovaldi, Gilead) and 100 mg each of velpatasvir and voxilaprevir (sof/vel/vox).

It would be the first once-daily single tablet regimen available as a salvage therapy for patients with HVC genotypes 1 through 6 infection who have failed prior treatment with direct-acting antiviral regimens including NS5A inhibitors, Gilead announced in a news release.

The data submitted in the NDA are from the phase 3 POLARIS-1 and POLARIS-4 studies and support the use of the regimen for 12 weeks in such patients without cirrhosis or with compensated cirrhosis, the company said.

Norbert Bischofberger, PhD
Norbert Bischofberger

“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, executive vice president of research and development and chief scientific officer at Gilead, said in the 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.”

The sof/vel/vox fixed-dose combination was previously granted breakthrough therapy designation by the FDA for the treatment of patients with chronic HCV genotype 1 who previously failed an NS5A inhibitor-containing regimen.

Disclosures: Bischofberger works for Gilead.