– Harvoni Achieved Cure Rates (SVR12) of 100
Percent in Japanese Phase 3 Study –
– Eliminates Need for Interferon and
Ribavirin for Patients with Genotype 1 Hepatitis C –
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the
Japanese Ministry of Health, Labour and Welfare (MHLW) has approved
Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily
single tablet regimen for the treatment of chronic hepatitis C
genotype 1 infection in adults. Harvoni combines the NS5A inhibitor
ledipasvir with the nucleotide analog polymerase inhibitor
sofosbuvir, approved by the MHLW under the trade name Sovaldi® in
March 2015. Harvoni is indicated for the suppression of viremia in
patients with genotype 1 chronic hepatitis C virus (HCV) infection
with or without compensated cirrhosis, with a treatment duration of
12 weeks.
“Today’s approval significantly advances the standard of care
for chronic hepatitis C in Japan, as it eliminates the need for
interferon and ribavirin, which can be difficult to take and to
tolerate, and offers the majority of people with genotype 1
infection to be cured in as little as 12 weeks with a once-daily
pill,” said Professor Masashi Mizokami, MD, PhD, The Research
Center for Hepatitis and Immunology, National Center for Global
Health and Medicine, Ichikawa, Japan.
Primarily due to HCV, Japan has one of the highest rates of
liver cancer of any industrialized country. Of the more than one
million people in Japan chronically infected with HCV, 70-80
percent are infected with the genotype 1 strain of the virus.
Harvoni’s approval in Japan is supported by data from 318
treatment-naïve and treatment-experienced Japanese patients with
genotype 1 HCV infection randomized to ledipasvir/sofosbuvir
(n=157) or ledipasvir/sofosbuvir plus ribavirin (n=161) in the
Phase 3 clinical trial GS-US-337-0113. Of the 318 patients enrolled
in this study, 34 percent were ages 65 years or older and 23
percent had cirrhosis.
Among patients receiving 12 weeks of ledipasvir/sofosbuvir
without ribavirin, 100 percent (n=78/78) of treatment-naïve and 100
percent (n=79/79) of treatment-experienced patients achieved
sustained virologic response 12 weeks after completing therapy
(SVR12). Adverse events observed with ledipasvir/sofosbuvir without
ribavirin were generally mild and included nasopharyngitis (29
percent), headache (7 percent) and malaise (6 percent).
The approval is also supported by results from three Phase 3
studies (ION-1, ION-2 and ION-3) evaluating eight, 12 or 24 weeks
of ledipasvir/sofosbuvir among genotype 1 HCV patients. Trial
participants included patients from the United States, Europe and
Puerto Rico who were treatment-naïve or who had failed previous
treatment, including protease inhibitor-based regimens, and also
included patients with compensated cirrhosis. Trial participants in
the ribavirin-free arms (n=1,080) achieved SVR12 rates of 94 to 99
percent.
“Harvoni is a safe, simple and well-tolerated treatment. With
cure rates of up to 100 percent and without the need for interferon
or ribavirin, it offers genotype 1-infected patients a high
likelihood of cure,” said Norbert Bischofberger, PhD, Gilead’s
Executive Vice President, Research and Development, and Chief
Scientific Officer. “We are pleased to have partnered with the
medical community in Japan to demonstrate the safety and efficacy
of two significant advances in the treatment of chronic hepatitis C
– Harvoni for genotype 1 infection and Sovaldi for genotype 2
infection, which was approved just three months ago. We look
forward to making Harvoni available in Japan as quickly as
possible.”
Important Safety Information About
Harvoni in Japan
WarningsTreatment with Harvoni should be initiated by a
physician with sufficient knowledge and experience in the
management of patients with viral liver diseases who are
appropriately diagnosed to receive the treatment.
ContraindicationsHarvoni is contraindicated in the
following patients: Patients with a history of hypersensitivity to
the active substances or to any of the excipients; patients with
severe renal function impairment (eGFR<30mL/min/1.73m2) or
patients with renal insufficiency requiring dialysis.
Contraindications for Coadministration
Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp
Inducers: Carbamazepine, phenytoin, rifampin and St. John’s
wort should not be administered with Harvoni as they may
significantly decrease ledipasvir and sofosbuvir plasma
concentrations.
Important 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.
Related Products Not Recommended: Harvoni is not
recommended for use with other products containing sofosbuvir
(Sovaldi).
Adverse ReactionsThe major adverse reactions were
pruritus (3.2 percent), nausea (2.5 percent) and stomatitis (2.5
percent).
Drug InteractionsIn addition to carbamazepine, phenytoin,
rifampin and St. John’s wort, coadministration of Harvoni is also
not recommended with antacids, H2-receptor antagonists, proton-pump
inhibitors, rifabutin and phenobarbital. 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 digoxin
because the plasma concentration of digoxin may be increased.
Coadministration is also not recommended with rosuvastatin or
regimens containing 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 About
Sovaldi in Japan
WarningsTreatment with Sovaldi should be initiated by a
physician with sufficient knowledge and experience in the
management of patients with viral liver diseases who are
appropriately diagnosed to receive the treatment.
ContraindicationsSovaldi is contraindicated in the
following patients: Patients with a history of hypersensitivity to
the active substances or to any of the excipients; patients with
severe renal function impairment (eGFR<30mL/min/1.73m2) or
patients with renal insufficiency requiring dialysis.
Contraindications for Coadministration
Risk of Reduced Therapeutic Effect of Sovaldi Due to P-gp
Inducers: Carbamazepine, phenytoin, rifampin and St. John’s
wort should not be used with Sovaldi as they may significantly
decrease sofosbuvir plasma concentration, reducing its therapeutic
effect.
Important PrecautionsSince Sovaldi is recommended for use
in combination with ribavirin, the PRECAUTIONS of the ribavirin
package insert, including Warnings, Contraindications, Careful
Administration, Important Precautions, and Clinically Significant
Adverse Reactions, must be consulted.
Adverse ReactionsThe major adverse reactions observed in
combination with ribavirin were anemia/hemoglobin decreased (15.0
percent), headache (5.0 percent), malaise (4.3 percent), nausea
(4.3 percent) and pruritus (4.3 percent).
Drug InteractionsIn addition to carbamazepine, phenytoin,
rifampin and St. John’s wort, coadministration of Sovaldi is not
recommended with phenobarbital and rifabutin. Such coadministration
is expected to decrease the concentration of sofosbuvir, reducing
its therapeutic effect.
About GileadGilead 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
StatementThis 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 that physicians and patients may not see
advantages of Harvoni over other therapies and may therefore be
reluctant to prescribe the product, and the risk that payers may be
reluctant to approve or provide reimbursement for the product.
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 March 31, 2015, 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
and Harvoni is available at www.gilead.com.
Sovaldi and Harvoni 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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version on businesswire.com: http://www.businesswire.com/news/home/20150702005932/en/
Gilead Sciences, Inc.Investors:Patrick O’Brien, +1
650-522-1936Media (U.S.):Cara Miller, +1 650-522-1616Media
(Japan):Seiko Noma, +81-3-6837-0790
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