– 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 –
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 percent, respectively).
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 for Epclusa.
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® (www.MySupportPath.com) program. The program consists
of an integrated offering of support services for patients and
providers, among them:
- Call center staffed with associates
trained to help patients and their providers with insurance-related
needs.
- Education and support, including a 24/7
nursing support service line.
- The Epclusa Co-pay Coupon Programs,
which provide co-pay assistance for eligible patients with private
insurance who need assistance paying for out-of-pocket medication
costs. Most patients will pay no more than $5 per co-pay.
- The Support Path Patient Assistance
Program, which will provide Epclusa at no charge for eligible
patients with no other insurance options.
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 medication costs.
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 through Friday.
Global Availability
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 worldwide.
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
Contraindications
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.
Adverse Reactions
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.
Drug Interactions
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
clinical comments.
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 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 related companies.
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/20160628006005/en/
Gilead Sciences, Inc.Sung Lee, 650-524-7792InvestorsCara Miller,
650-522-1616Media
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