Data from Phase 3 Studies of Gilead’s Sofosbuvir for Hepatitis C
To Be Presented at 48^th Annual EASL Meeting; Findings Published Online Today
in The New England Journal of Medicine
International Liver Congress 2013
AMSTERDAM -- April 23, 2013
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that detailed results
from four Phase 3 clinical trials (NEUTRINO, FISSION, POSITRON and FUSION)
evaluating sofosbuvir, the company’s investigational once-daily nucleotide
NS5B inhibitor for the treatment of chronic hepatitis C virus (HCV) infection,
will be presented this week in oral sessions at the 48th Annual Meeting of the
European Association for the Study of the Liver (International Liver Congress
2013) in Amsterdam, The Netherlands. In addition, detailed results from the
four clinical studies have also been published online in two papers, ahead of
print, in The New England Journal of Medicine (NEJM).
In the four trials, sofosbuvir was administered to nearly 1,000 patients with
chronic HCV infection as part of an all-oral 12-week or 16-week treatment
regimen in combination with ribavirin (RBV) in genotypes 2 and 3, or with RBV
and pegylated interferon (peg-IFN) for 12 weeks in genotypes 1, 4, 5 and 6.
Overall SVR12 rates (sustained viral response 12 weeks after completing
therapy) from 50 to 90 percent were observed. Patients who achieve SVR12 are
considered cured of their HCV infection.
A description of the four Phase 3 studies and SVR12 results are summarized in
the table below. Detailed results from the Phase 3 studies of sofosbuvir are
available at www.nejm.org/online-first.
Sofosbuvir Phase 3 Studies
Study Population Treatment groups SVR12 Rates
Genotype 1/4/5/6 Sofosbuvir + RBV
NEUTRINO treatment-naïve + Peg-IFN for 12 90% (295/327)
Sofosbuvir + RBV 67% (107/253)
FISSION Genotype 2/3 treatment-naïve for 12 weeks or
Peg-IFN + RBV for 67% (162/243)
Sofosbuvir + RBV 78% (161/207)
POSITRON Genotype 2/3, IFN intolerant, for 12 weeks or
ineligible or unwilling Placebo for 12 0% (0/71)
Sofosbuvir + RBV 50% (50/100)
FUSION Genotype 2/3 for 12 weeks or
treatment-experienced Sofosbuvir + RBV 73% (69/95)
for 16 weeks
“There remains an urgent unmet medical need for individuals diagnosed with
chronic hepatitis C infection,” commented Ira Jacobson, MD, Chief of the
Division of Gastroenterology and Hepatology, Vincent Astor Distinguished
Professor of Medicine, The Joan Sanford I. Weill Medical College of Cornell
University, Attending Physician, New York-Presbyterian Hospital Cornell
Campus. “The breadth of data from the Phase 3 program evaluating sofosbuvir
will help physicians understand how to treat the disease in the future across
various HCV genotypes and patient populations.”
“In these particular studies, sofosbuvir-based HCV therapy demonstrated high
efficacy rates and a favorable safety profile while reducing the need for
interferon injections to 12 weeks, or eliminating interferon completely from
the regimen,” said Eric Lawitz, MD, President and Medical Director, The Texas
Liver Institute, University of Texas Health Science Center, San
Antonio.“Based on these findings, sofosbuvir, once approved, has the
potential to play an important role in addressing the global hepatitis C
The NS5b region of the HCV viral genome for all patients who relapsed was
sequenced and no S282T mutations were observed by population or deep
sequencing (1 percent cutoff). There was no change in susceptibility to
sofosbuvir or RBV observed by phenotypic analyses.
With the exception of one patient in FISSION who was non-compliant, relapse
accounted for all virologic failures. Adverse events were generally mild and
included fatigue, nausea, headache, insomnia, pruritis, anemia and dizziness.
Less than 2 percent of patients in the sofosbuvir treatment groups
discontinued due to adverse events.
On April 8, Gilead submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for sofosbuvir for the treatment of HCV infection.
The data submitted in the NDA support the use of sofosbuvir and RBV as an
all-oral therapy for patients with genotype 2 and 3 HCV infection, and for
sofosbuvir in combination with RBV and peg-IFN for treatment-naïve patients
with genotype 1, 4, 5 and 6 HCV infection.
Gilead plans to file for regulatory approval of sofosbuvir in other
geographies, including the European Union, in the second quarter of 2013. The
European Medicines Agency (EMA) has accepted Gilead’s request for accelerated
assessment for sofosbuvir, a designation that is granted to new medicines of
major public health interest. Accelerated assessment could shorten the EMA’s
review time of sofosbuvir by two months. Granting of accelerated assessment
does not guarantee a positive opinion from the CHMP or approval by the
Sofosbuvir is a nucleotide analogue inhibitor of the HCV NS5B protein, which
plays an essential role in HCV replication. Sofosbuvir is a direct-acting
agent, meaning that it interferes directly with the HCV life cycle by
suppressing viral replication. Sofosbuvir is intended to become a cornerstone
of interferon-free, all-oral treatment regimens for HCV that achieve higher
cure rates more rapidly and with fewer side effects than current therapeutic
options. 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 Pacific.
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 FDA and other
regulatory agencies may not approve sofosbuvir, and that any marketing
approvals, if granted, may have significant limitations on its use. Additional
clinical studies of sofosbuvir, including in combination with other compounds,
may not produce favorable results. As a result, Gilead may not be able to
successfully commercialize sofosbuvir, and may make a strategic decision to
discontinue its development if, for example, the market for the product fails
to materialize as expected. 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 Annual Report on Form 10-K for the year ended December 31, 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.
Gilead Sciences, Inc.
Patrick O’Brien, +1 650-522-1936
Cara Miller, +1 650-522-1616
Nick Francis, +44 (208) 587-2412
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