Health Canada approves hepatitis C drug with faster cure time

TORONTO – Health Canada has approved a once-daily tablet for the treatment of chronic hepatitis C that could transform treatment of the disease for thousands of Canadians.

The drug Sovaldi (sofosbuvir) is to be taken in combination with older medications to treat the main forms of hepatitis C, which is caused by a blood-borne virus. Left untreated, the disease can lead to liver failure, cirrhosis and cancer.

An estimated 250,000 Canadians are living with chronic hepatitis C. But because the disease can take many years to progress without causing noticeable symptoms — even up to two or three decades —about 35 per cent have no idea they are infected.

Baby boomers are disproportionately affected by hepatitis C: they are five times more likely than people of other age groups to have contracted the virus, often from sharing needles for IV drug use or having sex with an infected person during their youth.

The Canadian Liver Foundation recommends that all Canadians born between 1945 and 1965 be tested for the virus.

Current treatments for the hepatitis C virus (HCV), which can take up to a year to complete, involve weekly injections of a drug that causes flu-like side-effects and cures about three out of four patients.

In clinical trials, 90 per cent of patients taking a single daily Sovaldi pill in combination with an older drug cocktail were cured in 12 weeks. However, the length of treatment and specific drug combination used depends on which of several genetic subtypes of the virus has caused a person’s infection.

The current standard of care for HCV in Canada involves up to 48 weeks of therapy with an interferon drug, which may not be suitable for certain patients.

“I believe sofosbuvir has the potential to transform HCV treatment in Canada as it addresses many unmet patient needs,” said Dr. Jordan Feld, a liver specialist at Toronto Western Hospital. “The high cure rates, shortened treatment duration and potential to eliminate or reduce interferon injections give us our best opportunity to successfully treat Canadians with hepatitis C.”

Sovaldi is made by Gilead Sciences Inc., based in Foster City, Calif., one of a half-dozen companies battling over the market for more effective hepatitis C treatments.

Gilead Sciences Canada said Monday the cost of Sovaldi to consumers won’t be available until the prescription drug goes on sale in pharmacies in early January, as the company is currently finalizing the price with regulatory authorities.

In the U.S., where the drug was approved by the FDA about two weeks ago, the parent company said a 12-week supply of Sovaldi would cost $84,000. That price could as much as double for patients with a subtype of the disease that would require them to take the drug longer.

Gilead Sciences Canada said it will launch a program Jan. 6 to provide support services for patients and health-care providers, including access to case managers to help with insurance-related needs. Another program will provide financial assistance for eligible patients who need help paying for out-of-pocket medication costs.