-- Pediatric approval of protease
inhibitor-free, pan-genotypic, pan-fibrotic, once-daily regimen
supports HCV elimination efforts by providing critical option for
broad range of populations --
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the
U.S. Food and Drug Administration (FDA) has approved a supplemental
New Drug Application (sNDA) for Epclusa® (sofosbuvir
400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for
the treatment of people with chronic hepatitis C infection (HCV) as
young as 6 years of age or weighing at least 17 kg, regardless of
HCV genotype or liver disease severity. The recommended dosage of
Epclusa in children ages 6 years and older is based on weight and
liver function. Epclusa is the first pan-genotypic, protease
inhibitor-free regimen approved in the United States for adults and
children.
In the United States, there are approximately 23,000-46,000
children living with HCV. Children born to mothers with HCV are a
growing concern, increasing in prevalence by 60 percent from 2011
to 2014. Additionally, engagement in high‐risk practices, such as
intravenous drug use, is an increasingly common route of HCV
transmission in adolescents and young adults.
“While the treatment of HCV has been transformed in recent
years, physicians caring for some children have still needed to
take several factors into consideration, including genotype and
liver disease severity, when selecting the appropriate treatment
plan,” said Kathleen B Schwarz, M.D., Professor of Pediatrics,
Johns Hopkins University School of Medicine. “The expanded approval
of Epclusa can help eligible children living with HCV combat this
life-threatening and debilitating disease.”
The approval of Epclusa is based on data from a Phase 2,
open-label clinical trial (Study 1143) that enrolled 175 children
who were treated with Epclusa for 12 weeks, of which 173 were
included in the efficacy analysis. In children 12 to <18 years
old, treatment with Epclusa resulted in a cure rate (SVR12) of 93
percent (71/76) in those with genotype 1 HCV infection and 100
percent in those with genotype 2 (6/6), genotype 3 (12/12),
genotype 4 (2/2) and genotype 6 (6/6) HCV infection. In children 6
to <12 years old, the SVR rate was 93 percent (50/54) in those
with genotype 1 HCV infection, 91 percent (10/11) in those with
genotype 3 HCV infection, and 100 percent in those with genotype 2
(2/2) and genotype 4 (4/4) HCV infection. The safety profile of
Epclusa in children 6 years of age and older treated was generally
consistent with that observed in clinical trials in adults. The
most common adverse reactions (incidence greater than or equal to
10 percent, all grades) observed with treatment with Epclusa for 12
weeks in adults are headache and fatigue.
“Gilead’s continued commitment to HCV elimination includes
bringing our medicines to the most difficult-to-cure populations
and today’s decision by the FDA represents an important step toward
that goal,” said Merdad Parsey, MD, PhD, Chief Medical Officer,
Gilead Sciences. “With consistently high cure rates in clinical
trials and in the real world, Epclusa has the potential to help
many of the children living with HCV in the United States.”
For adults, Epclusa was first approved by the FDA and European
Medicines Agency (EMA) in 2016. A line extension application for
the use of Epclusa in children aged 6 to <18 years of age is
currently under review with the EMA.
The U.S. product label for Epclusa contains a BOXED WARNING for
the risk of hepatitis B reactivation in HCV/HBV co-infected
patients. See below for U.S. Important Safety Information.
IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR THE USE
OF EPCLUSA
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 ribavirin (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 Use 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 cirrhotics were fatigue, anemia, nausea, headache,
insomnia, and diarrhea.
Drug Interactions
Coadministration is not recommended with topotecan due to
increased concentrations of topotecan; or 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.
INDICATION
EPCLUSA is indicated for the treatment of adult and pediatric
patients 6 years of age and older or weighing at least 17 kg with
chronic hepatitis C virus 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, 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 Epclusa for the treatment of chronic HCV infection and
the possibility of unfavorable results from ongoing and additional
clinical studies involving Epclusa. Further, there is the
possibility that the European Commission may not approve the line
extension application for the use of Epclusa in the currently
anticipated timelines or at all. 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 Annual Report
on Form 10-K for the year ended December 31, 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. Prescribing Information for Epclusa,
including BOXED WARNING, is available at www.gilead.com.
Epclusa and Gilead are registered trademarks of
Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) 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/20200319005700/en/
Douglas Maffei, Ph.D., Investors (650) 522-2739
Sonia Choi, Media (650) 425-5483
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