Gilead applies for PrEP approval in Canada

It’s official – Gilead has applied to Health Canada for Truvada to be approved as PrEP – an HIV pre-exposure prophylaxis. Truvada, a combination of the drugs Tenofovir/emtricitabine, is highly effective at preventing HIV when taken daily. It has been recommended for people at high risk of acquiring HIV by UNAIDS, the World Health Organization, […]

Love + Sex Sexual Health Kevin Moroso

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It’s official – Gilead has applied to Health Canada for Truvada to be approved as PrEP – an HIV pre-exposure prophylaxis.

Truvada, a combination of the drugs Tenofovir/emtricitabine, is highly effective at preventing HIV when taken daily. It has been recommended for people at high risk of acquiring HIV by UNAIDS, the World Health Organization, the U.S. Centers for Disease Control, and the International Aids Society. It has already been approved as PrEP in the United States where uptake has been seeing dramatic growth.

Truvada is already approved by Health Canada to be used in the treatment of HIV-positive people. However, it is not approved as PrEP yet in Canada which means doctors must prescribe it off-label and it is not yet on any provincial drug plan formularies outside of Quebec. Gilead Pharmaceuticals has now formally submitted its application to Health Canada for Truvada to also be approved for a preventative indication, otherwise known as pre-exposure prophylaxis. Much of this can be attributed to a petition launched in April by several HIV and gay men’s health organizations in Canada, calling on Gilead to apply to Health Canada. Gilead formally altered its policy position paper on PrEP to reflect that is has now applied for approval in Canada.

It is unknown how long it will take Health Canada to review Gilead’s application. Some are estimating a 12 month period is standard but many hope that additional political pressure may push Health Canada to expedite the process given current rates of infection. If Health Canada approves the application, it is then up to the provinces to add it to their provincial drug plan formularies and, more importantly, provide no cost access to people at high risk of acquiring HIV. Stay tuned for further information on what you can do to help ensure gay men at risk can get this drug as soon as possible in Canada!

2015.08.26 Gilead submits application

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