There is a drug to prevent HIV. Why isn’t it approved in Canada?
Recent developments in prevention are pointing to worrying gaps in the community-based approach to HIV prevention in Canada.
Perhaps we have been used to having only a single prevention technology on our books for so long – think condoms – that our ducks are not always in a row when new ones like PrEP come along. Thus potholes in our response become apparent – and none leap in to fix them.
After a series of somewhat inconclusive PrEP trials, whose results were marred by adherence issues, the results of more stringent trials like the PROUD and IPERGAY studies are in, and they are good. So good, in fact, that it would now be foolish not to put PrEP right at the front of the shelf that features ways to stay HIV-negative.
Commendably, some agencies in Canada are quickly moving to add information about PrEP to their websites. Nothing is being done, though, to improve access to the technology in question. And that’s a huge fail, because the drug involved here (Truvada) is not licensed in Canada other than for therapeutic use. True, you may be able to get it “off-label” – prescribed for prevention purposes – if you have a cooperative doctor and a generous health insurance plan, or lots of money to afford it. Truvada will in fact cost you $700 to $1,000 per month. The bottom line? PrEP as an equal-access prevention tool for Canadians currently falls way short of its potential.
The FDA approved Truvada for prevention in the United States in July 2012. Elsewhere, the French group Nous sommes PrEP recently called for Truvada manufacturer Gilead to file an application in that country for the use of Truvada as PrEP and for the French healthcare system to cover the cost of PrEP, amongst other implementation activities. In Canada, we hear crickets.
Those engaged in prevention work should not only spread the word about PrEP and its potential, but also see that potential realized by addressing the access issues involved. We need guidelines for its use, too. Says CATIE’s James Wilton, “While the United States, South Africa and Quebec have developed PrEP guidelines for healthcare providers, no guidelines exist for other types of service providers or for healthcare providers in other parts of Canada or the world.”
Let’s make a start, though, by using our contacts with the drug industry to urge Gilead to file an application with Health Canada to license Truvada for PrEP in this country. The potential market is, after all, huge. Then let’s make sure that it’s covered by drug plans everywhere.
There are parallels elsewhere. One could argue that our response to another tool related to HIV prevention, home testing, is equally turgid. OraQuick, for instance – a seemingly reliable HIV home test kit available for about $40 in the United States – is not available in Canada. Neither is another test kit approved there, the Home Access HIV-1 Test System. Why? Their respective manufacturers have not applied for a licence in Canada. Meanwhile, prevention experts here scurry – again commendably – to increase testing opportunities, minus new and easy options for doing so, largely without addressing the access issue. (A notable exception is from the community of people living with HIV. Positive Living BC, for example, has recently urged Health Canada to provide and regulate home HIV test kits.)
What does all of this tell us? We need, I think, to become better at actually implementing some of the game-changing options in the prevention landscape that are now out there. The rewards, after all, are there for the taking.
Bob Leahy is a person living with HIV since 1993 who lives in Warkworth, Ontario. He is currently the editor of PositiveLite.com, Canada’s Online HIV Magazine.
This is increasingly becoming an urgent access issue. I read that Gilead is applying for a PrEP indication in Australia. It’s time we got our crickets (and ducks) in a row and move forward to create the necessary infrastructure (dedicated clinics), guidelines and reimbursement that allows access for all who make the informed choice to use PrEP.
Has there been any development or momentum in the last few months bringing Truvada to Canada? Is it really just that no one is doing the work to make it available or is there red tape in the drug companies/Canadian insurance policies stopping this from being accessible? Do you know if Trudeau mentions anything about Truvada in his platform for HIV awareness? Thanks in advance.
This tells all: http://www.positivelite.com/component/zoo/tag/news/Health%20Canada