- Vosevi is the First Once-daily
Single-Tablet HCV Regimen Approved as Salvage Therapy for Certain
Patients and Completes Gilead’s Portfolio of Sofosbuvir-based HCV
Direct-acting Antiviral (DAA) Treatments -
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the
U.S. Food and Drug Administration (FDA) has approved Vosevi™
(sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets,
a single-tablet regimen for the re-treatment of chronic hepatitis C
virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6
previously treated with an NS5A inhibitor-containing regimen, or
with genotype 1a or 3 previously treated with a
sofosbuvir-containing regimen without an NS5A inhibitor. The
approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4
studies, which evaluated 12 weeks of Vosevi in direct-acting
antiviral-experienced chronic HCV-infected patients without
cirrhosis or with compensated cirrhosis.
“Direct-acting antiviral regimens have transformed HCV treatment
and have allowed health care providers the fortunate opportunity to
cure many patients. However, for patients who require re-treatment,
there remains an unmet clinical need for an effective and
well-tolerated option,” said Ira Jacobson, MD, Chairman of the
Department of Medicine at Mount Sinai Beth Israel, New York City
and a principal investigator in the Vosevi clinical trials.
“Treatment with Vosevi resulted in high cure rates in clinical
studies of patients who were not previously cured with several
widely-prescribed DAA regimens and will provide physicians with an
important new therapeutic option that could offer hope for their
hardest-to-treat patients.”
Vosevi has a boxed warning in its product label regarding the
risk of hepatitis B virus (HBV) reactivation in HCV/HBV coinfected
patients. See below for important safety information.
Vosevi is the latest single-tablet regimen in Gilead’s portfolio
of sofosbuvir-based DAA treatments that offer people living with
HCV a short course of therapy to cure their HCV, with the
convenience associated with once-daily single-tablet regimens.
Since 2013, Gilead has brought to market four HCV treatments,
including 3 single-table regimens. To date, more than an estimated
1.4 million patients worldwide have been treated with
sofosbuvir-based regimens.
“The evolution of Gilead’s portfolio of HCV single-tablet
regimens has been driven by our commitment to address previously
unmet needs and put the possibility of cure within reach for as
many HCV patient populations as possible,” said John F. Milligan,
PhD, Gilead’s President and Chief Executive Officer. “The approval
of Vosevi completes our portfolio by fulfilling the unmet need for
an effective regimen for patients who could not be cured, despite
prior treatment with certain DAA regimens.”
The approval of Vosevi is supported by data from the POLARIS-1
study evaluating 12 weeks of treatment among adults with HCV
genotype 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis
who had failed prior treatment with an NS5A inhibitor-containing
regimen, as well as data from the POLARIS-4 study evaluating 12
weeks of treatment among adults with HCV genotypes 1a and 3 with or
without compensated cirrhosis who had failed prior treatment with a
sofosbuvir-containing regimen that did not include an NS5A
inhibitor. In these populations across the two studies, 340 of the
353 patients treated with Vosevi (96 percent) achieved the primary
endpoint of SVR12, defined as maintaining undetectable viral load
12 weeks after completing therapy.
The most common adverse events (≥10% of patients) among patients
who received Vosevi were headache, fatigue, diarrhea and nausea.
The proportion of subjects who permanently discontinued treatment
due to adverse events was 0.2% for subjects who received Vosevi for
12 weeks.
U.S. Patient Support
Program
To support these patients and their families, Gilead’s U.S.
Support Path® program provides information regarding access and
reimbursement coverage options to patients in the United States who
need assistance with coverage for their Gilead HCV medications,
including Vosevi. Support Path conducts benefits investigations and
provides patients with information regarding their insurance
options.
Further, the Vosevi Co-pay Coupon Program offers co-pay
assistance for eligible patients with private insurance who need
assistance paying for out-of-pocket medication costs.
To learn more about Support Path for Vosevi, please visit
www.MySupportPath.com or call 1-855-7-MYPATH (1-855-769-7284)
between 9:00 a.m. and 8:00 p.m. (Eastern), Monday through
Friday.
IMPORTANT SAFETY
INFORMATION
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN
HCV/HBV COINFECTED PATIENTS
Test all patients for evidence of current or prior hepatitis B
virus (HBV) infection before initiating treatment with Vosevi. HBV
reactivation has been reported in HCV/HBV coinfected patients who
were undergoing or had completed treatment with HCV direct acting
antivirals (DAAs) and were not receiving HBV antiviral therapy.
Some cases have resulted in fulminant hepatitis, hepatic failure,
and death. Cases have been reported in patients who are HBsAg
positive, in patients with serologic evidence of resolved HBV, and
also in patients receiving certain immunosuppressant or
chemotherapeutic agents; the risk of HBV reactivation associated
with treatment with HCV DAAs may be increased in patients taking
these other agents. Monitor HCV/HBV coinfected patients for
hepatitis flare or HBV reactivation during HCV treatment and
post-treatment follow-up. Initiate appropriate patient management
for HBV infection as clinically indicated.
Contraindications
- Vosevi is contraindicated with
rifampin.
Warnings and Precautions
- Serious Symptomatic Bradycardia When
Coadministered with Amiodarone: Amiodarone is not recommended
for use with Vosevi 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. A fatal cardiac arrest was reported in a patient taking
amiodarone who was coadministered a sofosbuvir containing regimen.
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 Vosevi with P-gp Inducers and/or Moderate
to Potent Inducers of CYP2B6, CYP2C8 or CYP3A4: St. John’s wort
and carbamazepine are not recommended for use with Vosevi as they
may significantly decrease sofosbuvir, velpatasvir, and/or
voxilaprevir plasma concentrations.
Adverse Reactions
- The most common adverse reactions
(≥10%, all grades) with Vosevi were headache, fatigue, diarrhea,
and nausea.
Drug Interactions
- Coadministration of Vosevi is not
recommended with phenytoin, phenobarbital, oxcarbazepine,
rifabutin, rifapentine, atazanavir, lopinavir,
tipranavir/ritonavir, efavirenz, rosuvastatin, pitavastatin, and
cyclosporine due to changes (decreased or increased) in
concentrations of sofosbuvir, velpatasvir, voxilaprevir, and/or the
other agent.
Consult the full Prescribing Information for Vosevi 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 the risk that physicians may not see the benefits of
prescribing Vosevi for the treatment of adults with chronic HCV
infection. 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, 2017, 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 Vosevi,
including BOXED WARNING, is available
at www.gilead.com.
Vosevi is a 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170718006234/en/
Gilead Sciences, Inc.InvestorsSung Lee, 650-524-7792orMediaMark
Snyder, 650-522-6167
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Apr 2023 to Apr 2024