Thursday, December 8, 2016

Gilead Submits NDA to FDA for Sofosbuvir/Velpatasvir/Voxilaprevir HCV Genotype 1-6

Gilead Submits New Drug Application to U.S. Food and Drug Administration for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir

- If Approved, SOF/VEL/VOX Would Be the First Once-Daily Single Tablet Regimen Available as a Salvage Therapy for Patients Infected with HCV Genotype 1-6 Who Have Failed Prior Treatment with DAA Regimens Including NS5A Inhibitors -
FOSTER CITY, Calif.--()--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients. The data submitted in the NDA support the use of the regimen for 12 weeks in DAA-experienced patients with genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis.

“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. “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 NDA for SOF/VEL/VOX is based on data from two Phase 3 studies (POLARIS-1 and POLARIS-4), which evaluated 12 weeks of the fixed-dose combination in DAA-experienced patients with hepatitis C genotypes 1-6, including those who failed prior treatment with an NS5A-containing regimen. Of the 445 patients treated with SOF/VEL/VOX, 430 (97 percent) achieved the primary efficacy endpoint of SVR12. The NDA is further supported by two additional Phase 3 studies (POLARIS-2 and POLARIS-3) in which 611 DAA-naïve HCV-infected patients received 8 weeks of SOF/VEL/VOX. The most common adverse events among patients who received SOF/VEL/VOX were headache, fatigue, diarrhea and nausea. These data were presented at the American Association for the Study of Liver Diseases (AASLD) annual meeting in November 2016.

The SOF/VEL/VOX fixed-dose combination is an investigational product and its safety and efficacy have not been established. It has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration for the treatment of chronic genotype 1 HCV patients who have previously failed an NS5A inhibitor-containing regimen.

About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

AASLD 2016 - Liver Meeting
Phase 3 POLARIS-1 Study
NATAP ​- Reported by Jules Levin review slides
Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks as a Salvage Regimen in NS5A Inhibitor-Experienced Patients With Genotype 1-6 Infection: The Phase 3 POLARIS-1 Study - (11/15/16)

Phase 3 POLARIS-2 Study
NATAP ​- Reported by Jules Levin review slides
A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6 HCV Infected Patients: The POLARIS-2 Study - (11/15/16)

POLARIS-2: Voxilaprevir safe, effective with Epclusa in multiple HCV genotypes

Phase 3 POLARIS-3 Study
NATAP ​- Reported by Jules Levin review slides
A Randomized, Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks for Patients with Genotype 3 HCV Infection and Cirrhosis: The POLARIS-3 Study - (11/15/16)

Adding Voxilaprevir to Sofosbuvir/Velpatasvir Effective for HCV Genotype 3: Presented at AASLD
​BOSTON -- November 17, 2016 -- Adding voxilaprevir to the combination tablet containing sofosbuvir and velpatasvir (Epclusa) for 8 weeks shows similar efficacy to sofosbuvir/velpatasvir alone for 12 weeks in the treatment of patients with hepatitis C virus (HCV) genotype 3 and cirrhosis.

Phase 3 POLARIS-4 Study
NATAP ​- Reported by Jules Levin review slides
A Randomized, Controlled, Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir or Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Patients With Genotype 1-6 HCV Infection: The POLARIS-4 Study - (11/14/16)

SOF/VEL/VOX Effective as Retreatment for Non-NS5A DAA Failures
By Debra Hughes, MS November 14, 2016
Treatment with single tablet sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for 12 weeks "is a highly effective salvage therapy" for patients who did not previously achieve sustained virologic response (SVR) following treatment with non-NS5A inhibitor-containing direct-acting antivirals (DAAs), results from the POLARIS-4 study presented at The Liver Meeting® 2016 have shown

NATAP ​- Reported by Jules Levin review slides​
Integrated Analysis of Sofosbuvir +Ribavirin, Ledipasvir/Sofosbuvir or Sofosbuvir/Velpatasvir for the Treatment of Genotype 4 Chronic HCV Infection - (11/15/16)

NATAP ​- Reported by Jules Levin review slides​
Integrated Resistance Analyses of HCV-Infected Patients Treated With Sofosbuvir, Velpatasvir, and Voxilaprevir for 8 and 12 Weeks From Phase 2 Studies - (11/14/16)

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