– Vosevi Provides a New Option for People
with HCV Who Have Not Achieved Cure with Prior Direct-Acting
Antiviral Treatment –
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the
China National Medical Products Administration (NMPA) has approved
Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a
once-daily single-tablet regimen for the treatment of chronic
hepatitis C virus (HCV) infection in adults without cirrhosis or
with compensated cirrhosis who have failed prior treatment with a
direct-acting antiviral (DAA) therapy.
The approval of Vosevi in China is supported by two global Phase
3 studies, POLARIS-1 and POLARIS-4, which evaluated 12 weeks of
treatment with Vosevi among adults with HCV genotype 1-6 with or
without compensated cirrhosis who had failed prior DAA treatment
with or without an NS5A inhibitor. Across POLARIS-1 and POLARIS-4,
97 percent of patients treated with Vosevi (n=431/445) achieved
SVR12, the primary endpoint to determine cure rate, defined as HCV
RNA undetectable 12 weeks after completing therapy.
“People who have not achieved HCV cure with direct acting
antiviral medicines are often faced with limited choices for
re-treatment,” said Professor Lai Wei, Director of Hepatology and
Pancreatic Center, Tsinghua University-affiliated Beijing Tsinghua
Changgung Hospital. “With high cure rates across all genotypes,
Vosevi is a promising option for people who require a new regimen
to potentially achieve an HCV cure.”
The most common adverse reactions (≥10 percent) experienced by
patients treated with Vosevi in POLARIS-1 and POLARIS-4 were
headache, fatigue, diarrhea and nausea. The proportion of patients
who permanently discontinued treatment with Vosevi due to adverse
events was 0.2 percent.
In China, approximately 10 million people are infected with HCV
and it is the fourth most commonly reported infectious disease. HCV
genotypes 1, 2, 3 and 6 account for more than 96 percent of all
cases.
“The approval of Vosevi in China means that many more patients
with difficult-to-treat chronic HCV infection now have another
chance at cure,” said Merdad Parsey, MD, PhD, Chief Medical
Officer, Gilead Sciences. “It also represents another important
step forward in achieving the public health goal of eliminating HCV
in China and worldwide.”
Vosevi received marketing approval from the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA) in
2017. In the United States, 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 U.S.
Important Safety Information and Indication.
U.S. Important Safety Information and
Indications for Vosevi
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
Risk of Hepatic Decompensation/Failure in Patients with
Evidence of Advanced Liver Disease: Post-marketing cases of
hepatic decompensation/failure, some fatal, have been reported in
patients treated with HCV NS3/4A protease inhibitor-containing
regimens, including Vosevi. Reported cases occurred in patients
with baseline cirrhosis with and without moderate or severe liver
impairment (Child-Pugh B or C). In patients with compensated
cirrhosis (Child-Pugh A) or evidence of advanced liver disease such
as portal hypertension, perform hepatic laboratory testing as
clinically indicated; and monitor for signs and symptoms of hepatic
decompensation such as the presence of jaundice, ascites, hepatic
encephalopathy, and variceal hemorrhage. Discontinue Vosevi in
patients who develop evidence of hepatic decompensation/failure.
Vosevi is not recommended in patients with moderate to severe
hepatic impairment or those with any history of prior hepatic
decompensation/failure.
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) observed
with treatment with VOSEVI for 12 weeks 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.
U.S. INDICATION
Vosevi is indicated for the treatment of chronic hepatitis C
virus (HCV) infection in adults without cirrhosis or with
compensated cirrhosis who have failed prior treatment with an HCV
direct-acting antiviral (DAA) who have:
- genotype 1, 2, 3, 4, 5, or 6 infection and have previously been
treated with an HCV regimen containing an NS5A inhibitor
- genotype 1a or 3 infection and have previously been treated
with an HCV regimen containing sofosbuvir without an NS5A
inhibitor
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
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 September 30, 2019, 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 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: https://www.businesswire.com/news/home/20191220005282/en/
Greg Mann, Investors (424) 322-1795 Sonia Choi, Media (650)
425-5483
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