New Drug Application Submitted for Sofosbuvir/Velpatasvir/Voxilaprevir

New Drug Application Submitted to FDA for Sofosbuvir/Velpatasvir/Voxilaprevir~ A New Drug Application has been submitted to the FDA. If Approved, Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Would Be the First Once-Daily Single Tablet Regimen Available as a Treatment Resorted to when Preferred Therapies have been Tried, or a Salvage Treatment,  for Patients with Hep C Genotype 1-6 Who Have Failed Prior Treatment with DAA Regimens Including NS5A Inhibitors ~

The creator of the hepatitis C treatment SOF/VEL/VOX, Gilead, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the hep C treatment. SOF/VEL/VOX has been submitted as an once-daily single pill regimen for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients.

The Data Submitted in the New Drug Application (NDA)

The data submitted in the NDA, see below, supports the use of the regimen for 12 weeks in DAA treatment experienced patients with genotype 1 to 6 hep C who have or don’t have liver cirrhosis.

Clinical Trial Patients Genotype Duration Treatment SVR12
POLARIS-1 455 patients, including those who failed prior treatment with an NS5A-containing regimen, 41 percent (172/415) had cirrhosis 1-6 12 weeks SOF/VEL/VOX 96%
Placebo 0%
POLARIS-4 DAA-experienced (No NS5A inhibitor), 46 percent (153/333) had cirrhosis 1-4 12 weeks SOF/VEL/VOX 97%
SOF/VEL 90%
POLARIS-2 DAA-naive, 18 percent (174/941) had cirrhosis 1-6 8 weeks SOF/VEL/VOX 95%
12 weeks SOF/VEL 98%
POLARIS-3 DAA-naive, All had cirrhosis 3 8 weeks SOF/VEL/VOX 96%
12 weeks SOF/VEL 96%

Patients treated with SOF/VEL/VOX for 12 or 8 weeks experienced side effects similar to those treated with placebos. The most common side effects from SOF/VEL/VOX were headache, fatigue, diarrhea and nausea.

No news on or how the treatment may be submitted to Health Canada.

More Information

“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, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead.