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– Epclusa is the First and Only All-Oral, Pan-genotypic Single
Tablet Regimen for Chronic Hepatitis C Virus Infection and Gilead’s
Third Sofosbuvir-Based Regimen –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 28, 2016--
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food
and Drug Administration (FDA) has approved Epclusa®
(sofosbuvir 400 mg/velpatasvir 100 mg), the first all-oral,
pan-genotypic, single tablet regimen for the treatment of adults with
genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also
the first single tablet regimen approved for the treatment of patients
with HCV genotype 2 and 3, without the need for ribavirin. Epclusa for
12 weeks was approved in patients without cirrhosis or with compensated
cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for
patients with decompensated cirrhosis (Child-Pugh B or C).
“The approval of Epclusa represents an important step forward in the
global effort to control and potentially eliminate HCV as it provides a
safe, simple and effective cure for the majority of HCV-infected
patients, regardless of genotype,” said Ira Jacobson, MD, Chairman of
the Department of Medicine at Mount Sinai Beth Israel, New York City and
a principal investigator in the Epclusa clinical trials. “Building on
the established backbone of sofosbuvir, Epclusa demonstrated
consistently high cure rates across all genotypes, including among
patients with genotype 2 and 3, who traditionally have required
ribavirin or other multi-pill regimens.”
Photos and multimedia gallery available at www.GileadHCVMedia.com.
The FDA granted Epclusa a Priority Review and Breakthrough Therapy
designation, which is given to investigational medicines that may offer
major advances in treatment over existing options.
Epclusa’s approval is supported by data from four international Phase 3
studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1,
ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotype 1-6 chronic
HCV infection, without cirrhosis or with compensated cirrhosis received
12 weeks of Epclusa. The ASTRAL-4 study randomized 267 patients with
genotype 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B),
to receive 12 weeks of Epclusa with or without RBV or 24 weeks of
Epclusa. The primary endpoint for all studies was SVR12.
Of the 1,035 patients treated with Epclusa for 12 weeks in the ASTRAL-1,
ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12. In
ASTRAL-4, patients with decompensated cirrhosis receiving Epclusa with
RBV for 12 weeks achieved a high SVR12 rate (94 percent) compared to
those who received Epclusa for 12 weeks or 24 weeks (83 percent and 86
Headache and fatigue were the most common adverse reactions (≥10
percent) experienced by HCV-infected patients treated with Epclusa in
ASTRAL-1, ASTRAL-2 and ASTRAL-3 and occurred at a similar or higher
frequency in placebo-treated patients. In the 87 HCV-infected patients
with decompensated cirrhosis treated with Epclusa and ribavirin in the
ASTRAL-4 study, fatigue, anemia, nausea, headache, insomnia and diarrhea
were the most common adverse reactions (≥10 percent). Two and four
patients treated with Epclusa and Epclusa with RBV respectively
discontinued treatment due to adverse events.
“Today’s approval represents a significant advance for patients with HCV
genotypes 2 and 3, who previously required more complex and costly
regimens,” said John Milligan, Ph.D., President and Chief Executive
Officer of Gilead. “As the first and only pan-genotypic cure for
hepatitis C, Epclusa has the potential to eliminate the need for
genotype testing, which can be a barrier to treatment in certain
resource-constrained settings. We look forward to making Epclusa
available to patients around the world as quickly as possible.”
Epclusa should not be administered with ribavirin in patients for whom
ribavirin is contraindicated. See below for Important Safety Information
U.S. Patient Support Program
To assist eligible hepatitis C patients in the United States with access
to Epclusa, Gilead has added the medicine to its Support Path®
program. The program consists of an integrated offering of support
services for patients and providers, among them:
Gilead also provides support to independent non-profit organizations
that provide assistance for eligible federally-insured and
privately-insured patients who need help covering out-of-pocket
To learn more about Support Path for Epclusa, please visit www.MySupportPath.com
or call 1-855-769-7284 between 9:00 a.m. – 8:00 p.m. Eastern, Monday
The prevalence of HCV genotypes varies regionally throughout the world.
In resource-limited settings genotype testing can often be costly or
unreliable, posing yet another barrier to treatment. As a pan-genotypic
therapeutic option, Epclusa eliminates the need for genotype testing and
has the potential to accelerate access to treatment for patients
Gilead is committed to helping enable access to Epclusa around the
world. Gilead works with a network of regional business partners,
generic licensing partners, the Medicines Patent Pool and other
stakeholders to expand treatment globally. Epclusa is already licensed
to Gilead’s 11 Indian manufacturing partners who may now begin
production and distribution of a generic version of this medicine for
101 developing countries.
IMPORTANT SAFETY INFORMATION
If EPCLUSA is used in combination with ribavirin (RBV), all
contraindications, warnings and precautions, and adverse reactions to
RBV also apply. Refer to RBV prescribing information.
Warnings and Precautions
Risk of Serious Symptomatic Bradycardia When Sofosbuvir Is
Coadministered with Amiodarone and Another HCV Direct Acting Antiviral: Amiodarone
is not recommended for use with EPCLUSA due to the risk of symptomatic
bradycardia, particularly in patients also taking beta blockers or with
underlying cardiac comorbidities and/or with advanced liver disease. In
patients without alternative, viable treatment options, cardiac
monitoring is recommended. Patients should seek immediate medical
evaluation if they develop signs or symptoms of bradycardia.
Risk of Reduced Therapeutic Effect Due to Concomitant Use of EPCLUSA
with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8
or CYP3A4: Rifampin, St. John’s wort, and carbamazepine are not
recommended for use with EPCLUSA as they may significantly decrease
sofosbuvir and/or velpatasvir plasma concentrations.
The most common adverse reactions (≥10%, all grades) with EPCLUSA were
headache and fatigue; and when used with RBV in decompensated cirrhotics
were fatigue, anemia, nausea, headache, insomnia, and diarrhea.
Coadministration of EPCLUSA is not recommended with topotecan due to
increased concentrations of topotecan.
Coadministration of EPCLUSA is not recommended with proton-pump
inhibitors, oxcarbazepine, phenobarbital, phenytoin, rifabutin,
rifapentine, efavirenz, and tipranavir/ritonavir due to decreased
concentrations of sofosbuvir and/or velpatasvir.
Consult the full Prescribing Information for EPCLUSA for more
information on potentially significant drug interactions, including
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.
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 risks that
physicians and patients may not see advantages of Epclusa over other
therapies and may therefore be reluctant to prescribe the product, and
the risk that payers may be reluctant to approve or provide
reimbursement for the product. 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 March 31, 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.
U.S. Full Prescribing Information for Epclusa is available at www.gilead.com.
Epclusa is a registered trademark of Gilead Sciences, Inc., or its
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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Source: Gilead Sciences, Inc.
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