Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Sovaldi® (sofosbuvir) for the Treatment of Genotype 2 Chronic Hepatitis C
-- Sovaldi Part of First All-Oral Treatment Regimen for Genotype 2
-- 96 Percent Cure Rates and Shortened, 12-Week Course of Therapy --
“Today’s approval represents an important step forward in the management
of hepatitis C in Japan, enabling genotype 2 infected patients the
opportunity of a cure in 12 weeks with an all-oral regimen that
eliminates the need for interferon,” said
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 chronically infected with HCV, 20-30 percent have the genotype 2 strain of the virus. Currently approved therapies in Japan for genotype 2 HCV infection involve 24-48 weeks of injections with pegylated interferon, which may not be suitable for many patients.
Sovaldi’s approval is supported by data from a Phase 3 clinical trial conducted in Japan (Study GS-US-334-0118) among treatment-naïve and treatment-experienced genotype 2 patients. Approval was based on 96 percent (n=135/140) of genotype 2 HCV-infected patients who received 12 weeks of an all-oral regimen of Sovaldi plus RBV 600–1,000 mg/day achieving a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. The approval is also supported by SVR12 results from four international Phase 3 studies (FISSION, FUSION, POSITRON and VALENCE), which included genotype 2 HCV patients.
“There is a need in Japan for new HCV treatment options that are more
effective and better tolerated and we have been pleased to partner with
the medical community here in
Gilead filed a New Drug Application (NDA) in
IMPORTANT SAFETY INFORMATION
Use with potent P gp inducers: Drugs that are potent P-gp inducers in the intestine are expected to decrease sofosbuvir plasma concentration. Sovaldi is contraindicated in patients receiving the following substances: carbamazepine, phenytoin, rifampicin or St. John’s wort. Also, Sovaldi should be administered with care when coadministered with the following drugs: rifabutin, and phenobarbital.
Contraindications: Sovaldi is contraindicated in patients with severe renal function impairment (eGFR<30 mL/min/1.73m2) or patients with renal insufficiency requiring dialysis.
Anemia occurred in patients receiving Sovaldi in combination with ribavirin. Patients should be carefully observed and hemoglobin should be periodically monitored and appropriate measures should be taken including ribavirin dose adjusted according to the ribavirin package insert. If ribavirin is permanently discontinued, Sovaldi should also be discontinued.
Adverse reactions: In the Japanese Phase 3 clinical study, 61 of 140 (43.6 percent) patients experienced adverse reactions, including abnormal laboratory test values. The major adverse reactions were 21 anemia/hemoglobin decreased (15.0 percent), 7 headache (5.0 percent), 6 malaise (4.3 percent), 6 nausea (4.3 percent), and 6 pruritus (4.3 percent).
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 and patients may not see advantages of Sovaldi 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. Further, the ledipasvir/sofosbuvir single
tablet regimen may not be approved in
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Gilead Sciences, Inc.
Patrick O’Brien, +1 650-522-1936
Cara Miller, +1 650-522-1616
Seiko Noma, +81-3-6837-0790 (Japan)