FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. Buy Trecator-Sc (Ethionamide) without Rx (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. Buy Combivir (Lamivudine - Zidovudine)
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. Viagra Pack-60 () without Rx 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. Capecitabine with no prescription 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-na"ive 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. Hoodia () with free Rx 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-na"ive and 100 percent
(n=79/79) of treatment-experienced patients achieved sustained virologic
response 12 weeks after completing therapy (SVR12). Buy Gymnema Sylvestre online 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. http://medicalquestionanswers.wordpress.com Trial participants
included patients from the United States, Europe and Puerto Rico who
were treatment-na"ive 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 .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 .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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