Gilead Seeks FDA Approval for New Hepatitis C Treatment

Gilead Sciences — drugmaker of hepatitis C treatment, sofosbuvir (Sovaldi) – announced its submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the approval of a single tablet, 12-week combination hepatitis C regimen for patients of all genotypes previously treated for the disease with direct-acting antivirals.

The combination investigational drug is proposed as a salvage therapy for patients with hepatitis C genotypes 1 through 6 who were not cured with previous treatments of direct acting antivirals, states a release from Gilead.

The proposed new regimen combines 400 mg of sofosbuvir, a nucleotide analog NS5B polymerase inhibitor, with 100 mg of velpatasvir, an NS5A inhibitor, and 100 mg of voxilaprevir, an investigational pangenotypic NS3/4A protease inhibitor (SOF/VEL/VOX). The FDA has granted the investigational drug breakthrough therapy designation for the treatment of patients with chronic genotype 1 hepatitis C who have previously failed an NS5A inhibitor-containing regimen, Gilead said.

“The remaining clinical need to treat hepatitis C patients is a safe and effective cure for patients who have failed previous therapy with DAA [direct-acting antiviral] regimens, including those with NS5A inhibitors,” Norbert Bischofberger, PhD, Gilead’s executive vice president of research and development and chief scientific officer, stated in the release. He added that the new regimen, if approved “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.”

Hepatitis C is a bloodborne virus that, if left unchecked, can cause serious liver damage for people who are chronically infected. Health officials estimate that there are at least three million people in the US who have the disease and millions more worldwide.

This latest application that Gilead submitted is based on data from its two phase 3 clinical trials called Polaris-1 and Polaris-4. The studies involved 445 patients with hepatitis C genotypes 1 through 6 who received the investigational fixed-dosed combination treatment for 12 weeks — including some who had received previous unsuccessful treatment with an NS5A-containing regimen and were not cured, according to the release.

Results from the Polaris 1 and 4 trials showed that 430 patients (97%) achieved the study’s primary efficacy endpoint of sustained virological response (SVR) at 12 weeks after treatment ended. The NDA submission also includes data from two other Polaris phase 3 trials.

The most common side effects for patients in the studies who received the investigational drug were headache, fatigue, diarrhea, and nausea.

Gilead obtained FDA approval for its blockbuster drug sofosbuvir in late 2013, making it one of the first companies to market new DAAs, which have higher cure rates of hepatitis C, work faster, and have fewer serious side effects than traditional treatments for the virus. The company also makes two other hepatitis C drugs, ledipasvir/sofosbuvir (Harvoni) and sofosbuvir/velpatasvir (Epclusa). Notice the latter includes the drugs sofosbuvir and velpatasvir, like the investigational drug does. This combination was approved by the FDA earlier this year for genotypes 1 through 6 in patients with or without cirrhosis.

Gilead’s full news release can be found here.

Related Coverage:

WHO Prequalifies Its First Hepatitis C Rapid Diagnostic Test

FDA Warns of Hepatitis B Reactivation with Some Hepatitis C Drugs

AbbVie Gets Breakthrough Therapy Designation to Test Pan-Genotypic Hepatitis C Drug