- 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 1-6Who Have Failed Prior Treatment with DAA
Regimens Including NS5A Inhibitors -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 8, 2016--
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.
About SOF/VEL/VOX
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.
Forward-Looking Statement
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that the FDA and other regulatory agencies may not approve the
SOF/VEL/VOX fixed-dose combination, and any marketing approvals, if
granted, may have significant limitations on its use. These risks,
uncertainties and other factors could cause actual results to differ
materially from those referred to in the forward-looking statements. The
reader is cautioned not to rely on these forward-looking statements.
These and other risks are described in detail in Gilead’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2016, as filed
with the U.S. Securities and Exchange Commission. All forward-looking
statements are based on information currently available to Gilead, and
Gilead assumes no obligation to update any such forward-looking
statements.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or1-650-574-3000.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161208005609/en/
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.InvestorsSung Lee, 650-524-7792MediaMark
Snyder, 650-522-6167
