- First HCV Direct-Acting Antivirals
Approved for Use in Adolescents -
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the
U.S. Food and Drug Administration (FDA) has approved supplemental
indications for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg)
tablets and Sovaldi® (sofosbuvir 400 mg) tablets for the treatment
of chronic hepatitis C virus (HCV) infection in adolescents without
cirrhosis or with compensated cirrhosis, 12 years of age and older,
or weighing at least 35kg. Harvoni was approved for pediatric
patients with genotype 1, 4, 5 or 6 chronic HCV infection. Sovaldi
was approved for pediatric patients with genotype 2 or 3 chronic
HCV infection, in combination with ribavirin. There are an
estimated 23,000-46,000 pediatric HCV patients in the United
States, most of whom were infected with the virus at birth.
“The approvals of Sovaldi and Harvoni for pediatric patients
will enable adolescents to finally benefit from interferon-free
treatment for HCV infection,” said Karen Murray, M.D., professor of
pediatrics at the University of Washington School of Medicine and
Seattle Children's. “These therapies address a significant unmet
medical need and represent an important advance for HCV-infected
adolescents.”
“Gilead’s goal is to develop and deliver treatments that provide
all patients with HCV the potential to be cured,” said Norbert
Bischofberger, Ph.D., Executive Vice President of Research and
Development and Chief Scientific Officer at Gilead. “For the first
time, children 12 and older in the United States with genotypes 1
through 6 chronic HCV infection now have options of two
direct-acting antiviral regimens that offer high cure rates while
eliminating the need for interferon injections.”
Harvoni and Sovaldi each have a boxed warning in their
respective product labels regarding the risk of hepatitis B virus
reactivation in HCV/HBV co-infected patients. See below for
important safety information.
Harvoni for Pediatric
Patients
The supplemental new drug application (sNDA) approval is
supported by data from an open-label clinical trial (Study 1116),
which evaluated 12 weeks of treatment with Harvoni once-daily in
genotype 1 treatment-naïve and treatment-experienced HCV-infected
adolescents 12 years of age and older without cirrhosis or with
compensated cirrhosis. The SVR12 rate was 98 percent overall
(98/100). No subject experienced on-treatment virologic failure or
relapse. Two subjects were lost to follow-up.
Adverse events were consistent with those observed in clinical
studies of Harvoni in adults. The most common adverse reactions
(≥10 percent, all grades) observed with treatment with Harvoni in
HCV-infected pediatric patients were fatigue, headache and
asthenia.
Sovaldi for Pediatric
Patients
The sNDA approval is supported by data from an open-label
clinical trial (Study 1112), which evaluated 12 or 24 weeks of
treatment with Sovaldi and weight-based ribavirin in adolescents 12
years of age and older with HCV genotype 2 or 3. The SVR12 rate was
100% (13/13) in genotype 2 patients and 97% (36/37) in genotype 3
patients. No subject experienced on-treatment virologic failure or
relapse. One patient was lost to follow up.
Adverse events were consistent with those observed in clinical
studies of Sovaldi in adults. The most common adverse reactions
(≥15 percent, all grades) observed with treatment with Sovaldi and
ribavirin for 12 or 24 weeks in HCV-infected pediatric patients
were fatigue, headache and nausea.
U.S. Patient Support
Program
To support these patients and their families, Gilead’s U.S.
Support Path® program provides information regarding access and
reimbursement coverage options to patients in the United States who
need assistance with coverage for their medications, including
Harvoni and Sovaldi. Support Path conducts benefits investigations
and provides patients with information regarding their insurance
options.
Further, the Harvoni and Sovaldi Co-pay Coupon Programs offer
co-pay assistance for eligible patients with private insurance who
need assistance paying for out-of-pocket medication costs.
Information about how to enroll can be found at either
https://www.harvoni.com/support-and-savings/onward or
https://www.sovaldi.com/coupons or by calling 1-855-7-MYPATH
(1-855-769-7284) between 9:00 a.m. and 8:00 p.m. (Eastern).
Important Safety Information for
Harvoni
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 Harvoni.
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 Harvoni 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
- Risk of Serious Symptomatic Bradycardia
When Coadministered with Amiodarone: Amiodarone is not recommended
for use with Harvoni 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 of
Harvoni Due to P-gp Inducers: Rifampin and St. John’s wort are not
recommended for use with Harvoni as they may significantly decrease
ledipasvir and sofosbuvir plasma concentrations.
Adverse Reactions
Most common (≥10%, all grades) adverse reactions were fatigue,
headache and asthenia.
Drug Interactions
- In addition to rifampin and St. John’s
wort, coadministration of Harvoni is also not recommended with
carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin,
rifapentine, and tipranavir/ritonavir. Such coadministration is
expected to decrease the concentration of ledipasvir and
sofosbuvir, reducing the therapeutic effect of Harvoni.
- Coadministration of Harvoni is not
recommended with simeprevir due to increased concentrations of
ledipasvir and simeprevir. Coadministration is also not recommended
with rosuvastatin or co-formulated
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
due to increased concentrations of rosuvastatin and tenofovir,
respectively.
Consult the full Prescribing Information for Harvoni for more
information on potentially significant drug interactions, including
clinical comments.
Important Safety Information for
Sovaldi
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
post-treatment 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 of peginterferon alfa and ribavirin for
a list of their contraindications.
Warnings and Precautions
- Risk of Serious Symptomatic Bradycardia
When Coadministered with Amiodarone and Another HCV Direct Acting
Antiviral (DAA): Amiodarone is not recommended for use with Sovaldi
in combination with another DAA 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 of
Sovaldi 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 (≥20%, all grades) adverse reactions 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.
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 may not see the benefits of
prescribing Harvoni or Sovaldi in pediatric patient populations
with 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 Annual Report on Form 10-K for
the year ended December 31, 2016, 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.
Full prescribing information for Harvoni and
Sovaldi, including BOXED WARNING, is available at
www.gilead.com.
Harvoni 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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Gilead Sciences, Inc.Sung Lee, 650-524-7792 (Investors)Mark
Snyder, 650-522-6167 (Media)
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