Press Releases
July 03, 2015
Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Harvoni®, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C
– 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 –
“Today’s approval significantly advances the standard of care for
chronic hepatitis C in
Primarily due to HCV,
Harvoni’s approval in
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
“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
Important Safety Information About Harvoni in
Warnings
Treatment 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.
Contraindications
Harvoni 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 Reactions
The major adverse reactions were pruritus
(3.2 percent), nausea (2.5 percent) and stomatitis (2.5 percent).
Drug Interactions
In 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
Warnings
Treatment 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.
Contraindications
Sovaldi 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 Precautions
Since Sovaldi is recommended for use
in combination with ribavirin, the PRECAUTIONS of the ribavirin package
insert, including Warnings, Contraindications,
Adverse Reactions
The 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 Interactions
In 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 Gilead
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 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
U.S. full Prescribing Information for Sovaldi and Harvoni is available at www.gilead.com.
Sovaldi and Harvoni are registered trademarks of
For more information on
View source version on businesswire.com: http://www.businesswire.com/news/home/20150702005932/en/
Source:
Gilead Sciences, Inc.
Investors:
Patrick O’Brien, +1
650-522-1936
Media (U.S.):
Cara Miller, +1 650-522-1616
Media
(Japan):
Seiko Noma, +81-3-6837-0790