Monday, January 6, 2014

Canada Sovaldi - Will provinces cover $1,000-a-pill HCV treatment?

Sovaldi is approved in HCV genotypes 1 and 4, treatment-naïve adults in combination with PEG-IFN and ribavirin and the first approved interferon-free treatment regimen for people with HCV genotypes 2 and 3.

Overall cure rates are at 80%, response rates and treatment duration varies, depending on genotype, viral and host factors.

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FDA BACKGROUND PACKAGE FOR SOFOSBUVIR

New Hep C drug approved in Canada

Provinces still have to choose whether to cover $1,000-a-pill treatment
Reported by Bryn Levy
Saskatchewan could be getting a new weapon in the fight against Hepatitis C.

Sovaldi, a drug manufactured by American company Gilead, was approved for sale in Canada back in December 2013.

The new medicine replaces a previous one used as part of a cocktail of drugs used to cure the condition, which progresses slowly, but eventually leads to scarring of the liver, cancer and death.

Gilead, the company that makes the drug,  claims it's better at dealing with genotypes of the disease where current medications don't have as high a success rate. It also requires a shorter course of treatment.

With 15 years experience treating bloodborne illnesses in addicts in the Prince Albert area, Dr. Leo Lanois said Sovaldi still isn't so different that it would eliminate the need for other drugs to be used in combination with it. Some of those carry the nastiest side effects of the process.

"[Hepatitis C treatments] all have the great flaw that they all require pegylated interferon, which is very hard for many people to take," he said.

The pegylated interferon is a drug that boosts a patients' immune response.  It can't be used by people who have immune conditions like psoriasis, or rheumatoid arthritis.

"If you've got rheumatoid arthritis (pegylated interferon) would cripple you," said Lanois.

Lanois said the immune booster also causes a flu-like syndrome and can trigger depression.  That's a serious problem due to the prevalence of Hep C among the province's intravenous drug users.

"HIV and Hep C are linked in this province to intravenous drug use and we have, unfortunately, a very high prevalence of intravenous drug users," he said.

The drug also comes with a stiff price tag.  A course of treatment runs over $80,000 (US) for patients in the U.S.

Kevin Wilson, executive director of the extended benefits branch of Saskatchewan Health's drug plan said there will still be some time before the pills are potentially covered in the province.

He explained that while the drug is approved for sale, there's still an assessment process for the provinces.

"There's a national agency, the Common Drug Review, that reviews new products on behalf of publicly funded drug plans," he said.  Wilson said that if Sovaldi is found to be a worthwhile treatment compared to current drugs, Saskatchewan would pool its rescources with other provinces to get the best price possible.

Lanois said restrictions are also a problem. While other provinces have changed their protocols as HIV treatment has progressed, Saskatchewan still won't cover current Hep C medications for people also infected with HIV. Lanois said that a large portion of the people that need treatment for Hep C are also infected with HIV.

"Hopefully the government will change its mind pretty soon and start funding it, but you know... every time you start funding a drug that costs $20,000 a month, that money's not there to treat other things."

Overall, Lanois said that while it's always a good thing when new treatments are made available, he doesn't think Sovaldi is anywhere close to the finish line

"This is just a very small step. I'm not really overly excited about this. I think it's nice to have.," said Lanois, adding that he hoped Hep C treatment would follow the trajectory of medications for HIV, which was quite expensive and carried a lot of complications at first, but has steadily gotten better.

"We're hoping tha tin a few years there will be drugs that will be much easier to take," he said. 

blevy@rawlco.com

Follow on Twitter: @BrynLevy

http://www.newstalk650.com/story/new-hep-c-drug-approved-canada/214471

1 comment:

  1. Wow, Solvadi's superiority to treatments such as Boceprevir and Telaprevir in terms of efficacy and side effect profile delivered in a 3 therapy is stunningly better. Drop out rates in Sofusbuvir study for Genotype 1 was 2%. Solvadi really needs to be made available to Canadians *now* notwithstanding the possibility of interferon-free cocktails years in the future. I find Dr. Lanois's blase attitude quite suprising in light of the consensus I've seen that says Solvadi is a game changer.

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