Rob Ferguson
Queen's Park Bureau
Doctors of patients with the potentially fatal liver disease hepatitis C are questioning why Ontario hasn’t followed the federal government and seven provinces in approving a widely acclaimed new drug.
Known by the brand name Incivek, the medication can dramatically shorten the treatment time for hep C, limiting the impact of side-effects like anemia and rashes, and it has been shown to cure the condition in a majority of new cases.
“It is ridiculous to take this much time,” said Dr. Morris Sherman, a hepatologist at University Health Network and associate professor of medicine at the University of Toronto.
“I don’t know why they’re stalling and what their concerns are, or whether there’s something behind the scenes I don’t know about.”
It’s been over a year since the Health Ministry’s committee to evaluate drugs began looking at Incivek, made by Vertex Pharmaceuticals Inc. of Cambridge, Mass., and approved by Health Canada in August of 2011.
A standard 12-week course of treatment costs $35,000, which is covered by provincial drug plans in Quebec, Nova Scotia, New Brunswick, Alberta, British Columbia, the Yukon and by private insurers.
The federal government covers it for First Nations patients with hep C. The disease is caused by a virus and spread by contact with infected blood, such as from drug needles, tranfusions or getting a tattoo. Sherman estimates as many as 200,000 Ontarians have it.
Scarborough resident Geoffrey Campbell, who contracted hep C in 1990 from an unknown source and is now losing his liver to cirrhosis, told the Star his doctor is hopeful he can try Incivek, which is used in combination with two other drugs, interferon and ribavirin.
Campbell, 57, had the latter two drugs in 1998 and 2004 treatments but they did not cure him, and he had to stop working three years ago because of debilitating fatigue, pain and life-threatening internal bleeding that has sent him to hospital for 27 days over the last two years.
“This drug could eliminate the need for me to have a liver transplant at some point,” said Campbell, formerly a carpet and furniture salesman for Eaton’s and Sears.
“I just want the treatment. It’ll help slow the deterioration of my liver. There’s a sense of urgency.”
Symptoms of hep C include extreme fatigue, joint and belly pain, itchy skin, sore muscles, dark urine and jaundice, although many people have the virus in their blood for years before being diagnosed.
A spokeswoman for Vertex said the company is “working closely” with the Health Ministry to allay concerns, including the side-effect of itchy rashes that can be serious in a small proportion of cases and require hospitalization.
“There have been ongoing discussions,” said Dawn Kalmar.
Health Ministry spokeswoman Zita Astravas said the drug is being independently evaluated by Ontario’s public drug program which “makes decisions . . . based on evidence provided by the manufacturer and advice from Ontario’s Committee to Evaluate Drugs.”
“We have a rigorous, evidence-based system. We want to make sure that absolutely every drug we fund will be effective for patients,” she added in a statement.
Astravas noted Ontario covers another drug, boceprevir, in the same class as Incivek, under the province’s “exceptional access program” since October 2011.
“The two drugs have shown similar results in treating chronic hepatitis C, so patients with hepatitis C do have access to treatment here in Ontario.”
Sherman said that another new hep C drug, which goes by the brand name Victrelis, also causes rashes, but the course of treatment is longer at between 28 and 48 weeks, compared with 12 for Incivek, which makes it his preferred medication.
“It’s easier to manage the side effects for a shorter period of time. The biggest problem is anemia,” he added, calling the rashes a “non-issue.”
“Most of the time the rash is mild.”
http://www.thestar.com/news/canada/article/1289612--ontario-doctors-question-long-wait-for-hepatitis-c-drug-incivek
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