October 16, 2014
Health Canada Issues Notice of Compliance for Gilead’s Harvoni™ (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C
-- Harvoni Provides High Cure Rates (SVR12), Shortens Treatment Duration and Eliminates Need for Interferon and Ribavirin --
Harvoni Product Photo (Photo: Business Wire)
“Chronic hepatitis C can lead to cirrhosis, liver cancer and liver transplantation and is a major cause of liver-related morbidity and mortality in Canada,” said Dr.
Gilead filed a New Drug Submission for Harvoni in
The marketing authorization for Harvoni is supported by data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. These studies included non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response rates. Trial participants in the ribavirin-free arms (n=863) achieved SVR12 rates of 94 to 99 percent. For full study details, see the Clinical Studies section of the Product Monograph.
Harvoni was well tolerated in the ION studies. Zero percent, less than 1 percent and 1 percent of patients treated for eight, 12 and 24 weeks, respectively, discontinued treatment due to adverse events, and fewer adverse events were observed in the ribavirin-free arms compared to the ribavirin-containing arms in all ION studies. The most common adverse reactions among patients treated with Harvoni (≥ 5 percent) were fatigue, headache, nausea, diarrhea and insomnia. See below for Important Safety Information regarding warnings and precautions, adverse reactions and drug interactions.
Patient Assistance Program in
To assist eligible hepatitis C patients in
For more information regarding the Momentum Program in
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
General: The safety and efficacy of Harvoni in combination with other anti-HCV medicines has not been studied. The sustained virologic response of Harvoni is reduced in treatment-experienced patients with HCV containing certain NS5A baseline mutations.
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 leading to reduced therapeutic effect of Harvoni and potential loss of virologic response.
Patients with Other HCV Genotypes: The safety and efficacy of Harvoni have not been studied in patients infected with HCV genotype 2, 4, 5 or 6 and has not been fully established in patients infected with genotype 3.
Risk of Increase in Tenofovir Exposure: Harvoni has been shown to increase tenofovir exposure when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat). The safety of tenofovir in the setting of Harvoni and a pharmacokinetic enhancer has not been established. Patients receiving Harvoni concomitantly with Stribild or tenofovir DF and a boosted HIV protease inhibitor should be monitored for tenofovir-associated adverse reactions.
Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir (Sovaldi).
Most common (≥10%, all grades) adverse reactions were fatigue and headache.
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.
The safety and efficacy of Harvoni in combination with simeprevir have not been established.
Consult the full Canadian Product Monograph for Harvoni for more information on potentially significant drug interactions, including clinical comments.
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 choose not to prescribe the product and payers may be reluctant to approve or provide reimbursement for the product. Further, pending marketing applications for Harvoni in the
Canadian Product Monograph for HARVONI is available at www.Gilead.ca.
Harvoni, Sovaldi and Gilead Momentum Support Program are trademarks or registered trademarks of
For more information on
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Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Michele Rest, 650-577-6935 (Media)