Gilead Sciences, Inc., a biopharmaceutical company, announced that Health Canada has issued a Notice of Compliance for 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, granted marketing authorization under the tradename Sovaldi in December 2013. The efficacy of Harvoni has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL.
“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. Robert Myers, Associate Professor and Director of the University of Calgary Viral Hepatitis Clinic. “With Harvoni, the majority of genotype 1 patients can be cured with a once-daily pill in as little as eight or 12 weeks without the need for interferon injections or ribavirin tablets, which are associated with significant side effects.”
Gilead filed a New Drug Submission for Harvoni in Canada on March 19, 2014 and was granted Priority Review by Health Canada. Gilead has filed private and public payer reimbursement submissions for Harvoni and was granted a Priority Review under the Common Drug Review process on October 6, 2014. Harvoni was approved in the United States on October 10, 2014 and granted a positive opinion by the Committee for Medicinal Products for Human Use in the European Union on September 25, 2014. Applications are pending in Australia and New Zealand.
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 per cent.
Harvoni was well tolerated in the ION studies. Zero percent, less than 1 per cent 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 per cent) were fatigue, headache, nausea, diarrhea and insomnia. See below for Important Safety Information regarding warnings and precautions, adverse reactions and drug interactions.
To assist eligible hepatitis C patients in Canada with access to Harvoni, Gilead Sciences Canada, Inc. has added the medicine to the Gilead Momentum Support Program, which provides an integrated offering of support services for patients and healthcare providers. The programme provides access to dedicated case managers to help patients and their providers with insurance-related needs, including identifying their coverage options through either private insurance or publicly funded programs. In addition, the programme provides financial assistance for eligible patients who need help paying for out-of-pocket medication costs.