VIDEO: PrEP approval in Canada stuck in limbo

Canadians forced to depend on off-label prescriptions


Dr Darrell Tan, an infectious diseases specialist at St Michael’s Hospital in Toronto, comments on Truvada’s current status in Canada. The drug, manufactured by Gilead, is currently approved in the treatment of HIV in Canada but not as a pre-exposure prophylaxis (PrEP). The United States Food and Drug Administration approved Truvada to be used for HIV prevention in 2012.

Truvada has yet to be approved for use as a pre-exposure prophylaxis (PrEP) in Canada, and it is unclear when or even if it will become available as a tool to prevent HIV infection.

Manufactured by Gilead, Truvada is a drug commonly given to people who are HIV-positive as part of their treatment regimens. Two years ago, the US Food and Drug Administration (FDA) approved it for a second use: to help prevent HIV infection. The FDA decision followed the groundbreaking iPrEx study, headed by principal researcher Robert Grant, which proved its effectiveness as an HIV prevention drug if taken daily.

In an email to Daily Xtra, a Gilead representative says the company has submitted filings seeking approval for Truvada to be used as a prevention drug (in addition to its primary use as a treatment for HIV) in Brazil, South Africa, Thailand and France. But Canada seems to be in limbo.

“After initial discussions with the European Medicines Agency and Health Canada, Gilead has not received any recent communications regarding a PrEP filing from either agency,” the Gilead representative writes. The representative has not yet responded to Daily Xtra’s requests for clarification regarding what was said in these “initial discussions.”

Health Canada says it won’t provide information on what approvals drug companies may or may not be seeking at any given time, stating that this is “proprietary information.”

We contacted Eric Morrissette, senior media relations advisor at Health Canada, to ask why there may have been no “recent communications” with Gilead after “initial discussions” but were told that this, too, is confidential information. However, Morrissette tells Daily Xtra that there is “no backlog” at Health Canada that would slow down communications.

In the above interview, Dr Darrell Tan, an infectious diseases specialist at St Michael’s Hospital in Toronto, considers the current status of Truvada in Canada and the potential implications of its still being in limbo.

Tan is also heading up a new study called PrEP 5, which will follow a group of men at high risk of acquiring HIV who are participating in a trial on the use of Truvada to potentially reduce their risk.

 

Presently, Canadians can get Truvada if their doctors agree to prescribe it off-label, a process that is also explained in the above video.

Daily Xtra published a four-part video series on PrEP in early 2014.

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