- Sovaldi-based Regimens Demonstrated High
Rates of Sustained Virologic Response or Cure for Chinese Hepatitis
C Infected Patients -
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the
China Food and Drug Administration (CFDA) has approved Sovaldi®
(sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase
inhibitor for the treatment of chronic hepatitis C virus (HCV)
infection. Sovaldi was approved for the treatment of adults and
adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2,
3, 4, 5 or 6 as a component of a combination antiviral treatment
regimen. Sovaldi is the first Gilead HCV medicine approved in
China.
The approval of Sovaldi is supported by a Phase 3 study
conducted in China, presented earlier this year at the Asian
Pacific Association for the Study of the Liver (APASL) meeting.
SVR12 (HCV RNA undetectable 12 weeks after completing therapy)
rates for Chinese HCV patients with genotype 1, 2, 3 or 6 ranged
from 92-100 percent. The study evaluated Sovaldi in combination
with ribavirin (RBV) or pegylated interferon+ribavirin (PegIFN+RBV)
across a range of difficult-to-cure patient populations, including
treatment-experienced patients and those with compensated
cirrhosis. In this study, the safety profiles of the regimens were
consistent with the known side effects of pegylated interferon
and/or ribavirin. The most common adverse events were hematological
abnormalities and pyrexia.
Professor Lai Wei, the principal investigator of Sovaldi’s Phase
3 study and former Chairman of the Chinese Society of Hepatology of
the Chinese Medical Association said, “The approval of sofosbuvir
in China provides more treatment options for Chinese HCV patients.
The clinical trials in China and around the world provide evidence
that the treatment is effective for multiple genotypes, which
offers HCV patients in China a better chance at curing their
disease.”
HCV is the fourth-most commonly reported infectious disease in
China, with approximately 10 million people infected. HCV genotypes
1, 2, 3 and 6 account for more than 96 percent of all cases. Less
than one percent of HCV patients are currently treated, using
interferon-based regimens that have lower efficacy, longer
treatment duration and less favorable safety profiles than more
recent regimens that contain direct-acting antiviral medicines.
“With the approval of Sovaldi, there is now the potential
opportunity to transform treatment for HCV patients in China,” said
John F. Milligan, PhD, Gilead’s President and Chief Executive
Officer. “Medicines are one part of the solution but, as we have
seen in other countries around the world, there are many other
challenges that impact diagnosis, linkage to care and treatment.
Gilead is committed to working with the government and other
stakeholders with the goal to help reduce the significant burden of
HCV disease in China.”
Sovaldi received marketing approval from the U.S. Food and Drug
Administration (FDA) in 2013 and the European Commission in 2014.
It is also approved for use in 79 countries including Australia,
India, Indonesia, the Philippines, New Zealand, Canada, Egypt,
Switzerland and Turkey.
Gilead Sciences in China
Gilead has been present in China since 2007, starting with
manufacturing and growing over time to include the establishment of
commercial operations based in Shanghai in 2016.
Beyond the approval of Sovaldi, Gilead is studying its HCV
single-tablet regimens Harvoni® (ledipasvir/sofosbuvir) and
Epclusa® (sofosbuvir/velpatasvir) at clinical trials sites across
China, with the aim of providing important new treatment options to
Chinese HCV patients.
IMPORTANT SAFETY INFORMATION AND
INDICATION FOR SOVALDI IN U.S.
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 SOVALDI.
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 posttreatment follow-up.
Initiate appropriate patient management for HBV infection as
clinically indicated.
Contraindications
- Contraindications to peginterferon alfa
and ribavirin also apply to SOVALDI combination treatment. Refer to
the Prescribing Information for peginterferon alfa and ribavirin
for a list of their contraindications.
Warnings and Precautions
- Serious Symptomatic Bradycardia When
Coadministered with Amiodarone: Amiodarone is not
recommended for use with SOVALDI 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 Use with P-gp Inducers: Rifampin and St. John's wort are
not recommended for use with SOVALDI as they may significantly
decrease sofosbuvir plasma concentrations.
- Risk Associated with Combination
Treatment: Because SOVALDI is used in combination with
other antiviral drugs for the treatment of HCV infection, consult
the Prescribing Information for these drugs.
Adverse Reactions
Most common adverse reactions (≥20%, all grades) for:
- SOVALDI + peginterferon alfa +
ribavirin combination therapy were fatigue, headache, nausea,
insomnia, and anemia.
- SOVALDI + ribavirin combination therapy
were fatigue and headache.
Drug Interactions
- In addition to rifampin and St. John's
wort, coadministration of SOVALDI is not recommended with
carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin,
rifapentine, and tipranavir/ritonavir. Such coadministration is
expected to decrease the concentration of sofosbuvir, reducing its
therapeutic effect.
Indication:
SOVALDI is indicated for the treatment of chronic hepatitis C
virus (HCV) infection as a component of a combination antiviral
treatment regimen:
- genotype (GT) 1 or 4 infected adults
without cirrhosis or with compensated cirrhosis, in combination
with pegylated interferon and ribavirin.
- GT 2 or 3 infected patients at least 12
years of age (or ≥35 kg) without cirrhosis or with compensated
cirrhosis, in combination with ribavirin.
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 in China may not see the
benefits of prescribing Sovaldi for the treatment 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 June 30, 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 Sovaldi,
including BOXED WARNING is available at www.gilead.com
SOVALDI, HARVONI and EPCLUSA are registered
trademarks 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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