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-- Initial Regulatory Filings Planned for Q2 2013 --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 19, 2013--
Gilead Sciences (Nasdaq:GILD) today announced topline results from the
Phase 3 FUSION study evaluating 12- and 16-week courses of therapy with
the once-daily nucleotide sofosbuvir plus ribavirin (RBV) in
treatment-experienced patients with genotype 2 or 3 chronic hepatitis C
virus (HCV) infection who failed prior treatment. The study met its
primary efficacy endpoint of superiority compared to a predefined
historic control sustained virologic response (SVR) rate of 25 percent.
In FUSION, 50 percent of patients (n=50/100) in the 12-week arm and 73
percent of patients (n=69/95) in the 16-week arm achieved SVR12 (p<0.001
for both arms).
“This study demonstrates that all-oral therapy with sofosbuvir provides
significant efficacy among difficult-to-treat hepatitis C patients who
could not be cured by prior regimens containing pegylated interferon and
now have limited treatment options,” said Norbert Bischofberger, PhD,
Executive Vice President of Research and Development and Chief
Scientific Officer. “With positive results from all four Phase 3 trials
now in hand, Gilead is on track to meet its goal of filing regulatory
applications in the United States and Europe in the second quarter.”
In the FUSION study, HCV genotype 2 or 3 patients who failed prior
interferon-based therapy were randomized (1:1) to receive either a
12-week (n=103) or 16-week (n=98) course of sofosbuvir 400 mg once daily
plus RBV (1,000 or 1,200 mg/day). Sixty-three percent of patients were
infected with genotype 3. In the 12-week arm, SVR12 rates were 86
percent among genotype 2 and 30 percent among genotype 3 patients. In
the 16-week arm, SVR12 rates were 94 percent among genotype 2 and 62
percent among genotype 3 patients. Among the 34 percent of FUSION
participants who had compensated cirrhosis at baseline, 31 percent
achieved SVR12 in the 12-week arm, and 66 percent achieved SVR12 in the
16-week arm. All patients in the study became HCV negative on treatment,
and relapse accounted for all virologic failures.
No patients discontinued sofosbuvir or RBV due to adverse events. The
most common adverse events reported in ≥15 percent of patients in the
study were fatigue, headache, insomnia and nausea.
Results from all four pivotal Phase 3 studies of sofosbuvir – FUSION,
POSITRON, FISSION and NEUTRINO – will support the initial regulatory
filing for sofosbuvir as part of all-oral therapy with RBV among
genotype 2 and 3 treatment-naïve, treatment-experienced and
interferon-intolerant HCV patients, and for sofosbuvir in combination
with RBV and pegylated interferon among treatment-naïve patients with
genotypes 1, 4, 5 and 6.
Full results from these studies will be presented at a future scientific
conference. Additional information about these and other ongoing
clinical studies of sofosbuvir can be found at www.clinicaltrials.gov.
Sofosbuvir is an investigational product and its safety and efficacy
have not yet been established.
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 worldwide. Headquartered in Foster City,
California, Gilead has operations in North America, Europe and Asia
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
possibility that the proportion of patients who maintain a sustained
virologic response with longer follow up will not be as favorable as the
sustained virologic response rates reported in this press release, and
the possibility of unfavorable results from other clinical trials
involving sofosbuvir. As a result, sofosbuvir may never be successfully
commercialized. In addition, Gilead may make a strategic decision to
discontinue development of the compound if, for example, Gilead believes
commercialization will be difficult relative to other opportunities in
its pipeline. Further, Gilead may be unable to file for regulatory
approval of sofosbuvir in the currently anticipated timelines or at all.
If marketing approval is granted for this product, there may be
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, 2012, 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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Patrick O’Brien, 650-522-1936 (Investors)Cara
Miller, 650-522-1616 (Media)