- If Approved, SOF/VEL/VOX Would Be the
First Once-Daily Single Tablet Regimen Available for Salvage for
Patients Who Have Failed Prior HCV Therapy with Oral Direct-Acting
Antiviral Agent Regimens -
- U.S. NDA Planned for Q4 2016 -
Gilead Sciences, Inc. (NASDAQ: GILD) today announced topline
results from four international Phase 3 clinical studies
(POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4) evaluating an
investigational, once-daily, fixed-dose combination of sofosbuvir
(SOF), a nucleotide analog NS5B polymerase inhibitor; velpatasvir
(VEL), a pangenotypic NS5A inhibitor; and voxilaprevir (VOX;
GS-9857), an investigational pangenotypic NS3/4A protease
inhibitor, for the treatment of genotype 1-6 chronic hepatitis C
virus (HCV) infection.
In the POLARIS-1 and POLARIS-4 studies, 445 patients with
genotype 1-6 HCV infection who were previously treated with
direct-acting antiviral agents (DAAs) received 12 weeks of
SOF/VEL/VOX. The POLARIS-1 study enrolled patients who failed prior
treatment with an NS5A inhibitor. The POLARIS-4 study enrolled
patients who failed prior treatment with a DAA that was not an NS5A
inhibitor, most with either an NS5B inhibitor alone (73 percent) or
an NS5B inhibitor and an NS3/4A protease inhibitor (25
percent).
In the POLARIS-2 and POLARIS-3 studies, 611 patients who were
not previously treated with a DAA received 8 weeks of SOF/VEL/VOX.
The POLARIS-2 study enrolled patients with genotype 1-6 HCV
infection with or without compensated cirrhosis. The POLARIS-3
study enrolled patients with genotype 3 HCV infection, all of whom
had compensated cirrhosis.
The primary endpoint for all studies was SVR12. The
intent-to-treat SVR12 rates observed in the POLARIS studies are
summarized in the following table. Complete results from all four
studies will be presented at The Liver Meeting® 2016 in Boston.
Study Population Genotype
Treatment Duration SVR12 Rates
POLARIS-1 NS5A inhibitor-experienced
41 percent (172/415) had cirrhosis
1, 2, 3, 4, 5, 6 SOF/VEL/VOX 12 Weeks
96%
(253/263)
Placebo 12 Weeks 0%
(0/152)
POLARIS-4
DAA-experienced (No NS5A inhibitor)
46 percent (153/333) had cirrhosis
1, 2, 3, 4 SOF/VEL/VOX 12 Weeks 97%
(177/182)
SOF/VEL 12 Weeks 90%
(136/151)
POLARIS-2 DAA-naïve
18 percent (174/941) had cirrhosis
1, 2, 3, 4, 5, 6 SOF/VEL/VOX 8 Weeks 95%
(476/501)
SOF/VEL 12 Weeks 98%
(432/440)
POLARIS-3 DAA-naïve
All had cirrhosis
3 SOF/VEL/VOX 8 Weeks 96%
(106/110)
SOF/VEL 12 Weeks 96%
(105/109)
Patients treated with SOF/VEL/VOX for 12 or eight weeks had
similar overall incidence of adverse events compared to
placebo-treated or SOF/VEL-treated patients. The most common
adverse events among patients who received SOF/VEL/VOX were
headache, fatigue, diarrhea and nausea. Among the 1,056 patients
who received SOF/VEL/VOX in the four studies, one patient (less
than one percent) receiving SOF/VEL/VOX for 12 weeks discontinued
due to an adverse event.
“Despite recent advances that have provided high cure rates and
simplified treatment for most HCV patients, those who have failed
previous treatment with direct acting antivirals continue to
represent an unmet medical need. The POLARIS study results
demonstrate that combining three potent antivirals with different
mechanisms of action and high barriers to resistance can provide
high cure rates for patients who have failed other highly effective
oral DAA regimens,” said Norbert Bischofberger, Ph.D., Executive
Vice President of Research and Development and Chief Scientific
Officer at Gilead. “Based on these Phase 3 results, we plan to
submit regulatory applications for SOF/VEL/VOX for the treatment of
chronic HCV in the United States in the fourth quarter of 2016 and
shortly thereafter in Europe.”
About the POLARIS
Studies
The POLARIS-1 study was a double-blind, placebo-controlled study
in 415 genotype 1-6 NS5A inhibitor-experienced patients. The most
common prior NS5A inhibitors were ledipasvir (55 percent) and
daclatasvir (23 percent).
The open-label POLARIS-4 study evaluated the use of SOF/VEL/VOX
or SOF/VEL for 12 weeks in 333 genotype 1-4 HCV-infected patients
with prior DAA experience that did not include an NS5A inhibitor.
Most patients (85 percent) had prior DAA experience with
sofosbuvir.
The open-label POLARIS-2 study evaluated the use of SOF/VEL/VOX
for eight weeks or SOF/VEL for 12 weeks in 941 genotype 1-6
DAA-naïve HCV-infected patients, including 18 percent with
cirrhosis and 23 percent who had previously failed treatment with
an interferon-based regimen.
The open-label POLARIS-3 study randomized patients with genotype
3 HCV infection and cirrhosis to receive SOF/VEL/VOX daily for
eight weeks or SOF/VEL for 12 weeks. Of the 219 patients treated,
31 percent had previously failed treatment with an interferon-based
regimen.
The POLARIS-1, POLARIS-3 and POLARIS-4 studies met their
respective pre-specified primary endpoints for the patients
receiving SOF/VEL/VOX. The POLARIS-2 study did not meet its primary
endpoint; with a pre-specified 5 percent margin, the SVR12 rate for
patients receiving treatment with SOF/VEL/VOX for eight weeks was
not statistically non-inferior to the SVR12 rate for patients
receiving SOF/VEL for 12 weeks.
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 future trials involving the SOF/VEL/VOX
fixed-dose combination may have unfavorable results. In addition,
Gilead may be unable to file for U.S. regulatory approval of the
SOF/VEL/VOX fixed-dose combination in the United States and Europe
in the currently anticipated timelines. In addition, 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 June 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 or 1-650-574-3000.
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version on businesswire.com: http://www.businesswire.com/news/home/20161020005942/en/
Gilead Sciences, Inc.InvestorsSung Lee, 650-524-7792MediaMark
Snyder, 650-522-6167
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