Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir)
January 08 2019 - 1:00AM
Business Wire
- Epclusa is the First Approved Treatment
for Adults with Chronic Hepatitis C Virus with Decompensated
Cirrhosis in Japan -
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved
Epclusa® (sofosbuvir 400mg/velpatasvir 100mg), a once-daily
treatment for adults with chronic hepatitis C virus (HCV) infection
with decompensated cirrhosis, and for patients with chronic HCV
infection without cirrhosis or with compensated cirrhosis who have
had prior treatment with a direct-acting antiviral therapy
(DAA).
Until now, no treatment option has been available in Japan for
the treatment of chronic HCV infection with decompensated
cirrhosis, and there have been limited treatment options for
patients with chronic HCV infection who have had prior treatment
with a DAA. Epclusa offers a new option for both of these
difficult-to-treat patient populations.
“Gilead has continued to develop new HCV therapies to help
ensure all people with HCV have a chance at cure and, ultimately,
to help eliminate the disease worldwide,” said John McHutchison,
AO, MD, Chief Scientific Officer, Head of Research and Development,
Gilead Sciences. “In Japan, people with HCV who have decompensated
cirrhosis or who did not achieve cure with prior HCV treatment, had
few to no treatment options until now. We are pleased to offer a
new treatment option to address this important clinical need in
Japan.”
Epclusa is a combination treatment that contains sofosbuvir, an
NS5B polymerase inhibitor that was approved in Japan as
Sovaldi® 400 mg tablets in March 2015, and velpatasvir, an
active ingredient that inhibits NS5A.
In Japan, Epclusa is indicated for the suppression of viremia in
patients with chronic HCV infection. Patients with chronic HCV
infection with decompensated cirrhosis should take one tablet of
Epclusa once daily for 12 weeks, and patients with chronic HCV
infection without cirrhosis or with compensated cirrhosis that have
had prior DAA treatment experience should take one tablet of
Epclusa once daily for 24 weeks, in combination with ribavirin
(RBV).
The approval of Epclusa in Japan is supported by data from a
Phase 3 clinical study in Japanese patients with HCV infection with
decompensated cirrhosis (Study GS-US-342-4019) in which 92 percent
(47/51) of patients who received Epclusa for 12 weeks achieved
SVR12 (defined as undetectable HCV RNA 12 weeks after completing
therapy). Patients who achieve SVR12 are considered cured of HCV.
In a separate Phase 3 clinical study in Japanese patients with
genotype 1 or 2 HCV infection who failed prior DAA therapy (Study
GS-US-342-3921), 97 percent (58/60) of patients who received
Epclusa with RBV for 24 weeks achieved SVR12. In both studies,
Epclusa was generally well tolerated. Among patients receiving
Epclusa for 12 weeks in GS-US-342-4019, the most common adverse
event was nasopharyngitis and no patient discontinued treatment
with Epclusa due to adverse events. Among patients receiving
Epclusa with RBV for 24 weeks in GS-US-342-3921, the most common
adverse events were viral upper respiratory tract infection and
anemia and 3.3 percent of patients discontinued Epclusa due to
adverse events.
The US Prescribing Information for Epclusa contains a Boxed
Warning regarding the risk of hepatitis B virus reactivation in
HCV/HIV co-infected patients. See below for US Important Safety
Information and Indication.
EPCLUSA US 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 EPCLUSA. 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
- If EPCLUSA is used in combination with
RBV, all contraindications, warnings and precautions, in particular
pregnancy avoidance, and adverse reactions to RBV also apply. Refer
to RBV prescribing information.
Warnings and Precautions
- Serious Symptomatic Bradycardia When
Coadministered with Amiodarone: 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. 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 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 cirrhosis 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.
US Indication
EPCLUSA is indicated for the treatment of adults with chronic
hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection
without cirrhosis or with compensated cirrhosis and in combination
with ribavirin for those with decompensated cirrhosis.
About Gilead
Sciences
Gilead Sciences 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. For more
information on Gilead Sciences, please visit the company’s website
at www.gilead.com.
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 Epclusa for the treatment of chronic HCV infection and
the possibility of unfavorable results from ongoing and additional
clinical studies involving Epclusa. 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, 2018, 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.
US Full Prescribing Information for Epclusa,
including BOXED WARNING, is available at www.gilead.com.
Epclusa® and Sovaldi® 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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