Game-changer HIV shot approved in US may enter Canada by 2026; Just two injections a year
A twice-a-year injectable drug being hailed as a breakthrough in
HIV
prevention could be available in
Canada
as early as mid-2026, offering new hope in the fight against the virus.
The drug,
lenacapavir
, developed by
Gilead Sciences
, was approved by the US Food and Drug Administration (FDA) last week for pre-exposure prophylaxis (PrEP). It is the first and only HIV prevention medication that requires just two doses per year. Gilead Canada submitted the drug to Health Canada in April for review, which was accepted earlier this month.
Lenacapavir was approved in Canada in 2022 for treatment, but this is the first time it's under review for prevention.
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'This is absolutely a monumental advance in prevention,' said Peter Newman, a professor at the University of Toronto whose work focuses on HIV prevention. 'It's certainly cost-effective in the long run because you're going to prevent a lot of cases of new HIV.'
How does it work
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Lenacapavir works by creating a slow-release 'depot' of medicine under the skin, delivering protection for six months. Clinical trials showed near-total effectiveness: among more than 2,000 high-risk women in Africa, zero new infections were recorded. In another trial among gay and bisexual men and transgender women, only two infections occurred, both in participants who were already HIV-positive before the injection.
Very expensive
Gilead's US list price is $28,218 a year, sparking concerns about access and affordability, especially for marginalized groups. 'We could get a lot of interest, but if people can't afford it, it's dead in the water,' O'Byrne said.
Currently in Canada, 54 percent of PrEP prescriptions are paid for by private insurance and 43 percent by public programs, according to the Public Health Agency of Canada. Gilead says it will work with both public and private payers to 'accelerate availability and access.'
If approved, the shot will only be available through healthcare providers, doctors, or nurses. But experts argue it should be expanded to include pharmacists and nurse practitioners, especially to increase access in remote or underserved areas.
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