- Sovaldi-based Regimens Demonstrated High Rates of Sustained
Virologic Response or Cure for Chinese Hepatitis C Infected Patients -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 25, 2017--
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
“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
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
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 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
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.
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.
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.
SOVALDI is indicated for the treatment of chronic hepatitis C virus
(HCV) infection as a component of a combination antiviral treatment
genotype (GT) 1 or 4 infected adults without cirrhosis or with
compensated cirrhosis, in combination with pegylated interferon and
GT 2 or 3 infected patients at least 12 years of age (or ≥35 kg)
without cirrhosis or with compensated cirrhosis, in combination with
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 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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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792