Health Canada issues notice of compliance for Gilead hepatitis C drug Harvoni

Granted marketing authorization under the trade-name Sovaldi in December 2013, Harvoni is a combination of the NS5A inhibitor ledipasvir and the nucleotide analog polymerase inhibitor sofosbuvir.

The marketing authorization for Harvoni is based on data from three Phase III trials ION-1, ION-2 and ION-3, which 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.

The trials 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).

University of Calgary Viral Hepatitis Clinic associate professor and director Dr Robert Myers said 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.

"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," Myers said.

The company filed a new drug submission for Harvoni in Canada on 19 March 2014 and was granted Priority Review by Health Canada.