A twice-a-year shot to prevent HIV being dubbed a “wonder drug” by some could be coming to Canada as soon as next year, though the company behind it says it could still take some time before the general population could access it.
Gilead Canada confirmed to Global News that it had submitted lenacapavir for pre-exposure prophylaxis (PrEP) use as a new injectable drug to Health Canada in April of this year and it had been accepted by the agency for review this month.
It said it anticipates the evaluation of the drug would be complete sometime in mid-2026.
Global News has inquired with Health Canada about potential approval time as well as a timeline for the approval process.
Canadian health-care experts and advocates for HIV prevention say the Gilead drug is a “monumental advance.”
“It’s absolutely a monumental advance in prevention,” said Peter Newman, a University of Toronto social work professor, whose work includes HIV prevention.
“These kinds of things could really help to get it out there quicker and it’s certainly cost-effective in the long run because you’re going to prevent a lot of cases of new HIV.”
The drug nearly eliminated new infections in two groundbreaking studies of people at high risk, better than the daily preventative pills people can forget to take, prompting the U.S. Food and Drug Administration to approve it in that country last week.
Condoms help guard against HIV infection if used properly, but what’s called PrEP — regularly using preventive medicines such as the daily pills or a shot given every two months — is increasingly important.
Lenacapavir’s six-month protection makes it the longest-lasting type, an option that could attract people wary of more frequent doctor visits or stigma from daily pills.
Lenacapavir was initially authorized by Health Canada in 2022 both as an injection and tablets for treatment of HIV, but not prevention.
The injection is given as two doses under the skin of the abdomen, leaving a small “depot” of medication to slowly absorb into the body.
Patrick O’Byrne, a nurse practitioner at the STI clinic in Ottawa, said unlike pills where a dose can be forgotten, injectables are less easy to forget.
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“It’s hard to mess it up. You can get your injection and it works,” O’Byrne said. “The injectables are much more forgiving, so they actually, in the studies, have better preventative outcomes because it’s less dependent on people.”
People must test negative for HIV before getting their twice-a-year dose, Gilead has warned.
Much like oral PrEP, the drug only prevents HIV transmission, not other sexually transmitted diseases.
According to Gilead, if approved, the twice-a-year shot must be administered by a health-care practitioner — a physician or a nurse.
But some advocates say it should be expanded.
“The shots are only twice a year, which cuts down on patients spending time in a waiting room,” said Sean Hosein, science and medicines editor at the Canadian AIDS Treatment Information Exchange, known as CATIE, which is funded by federal and provincial grants.
“But I also think another way to make prevention more widely available is to enable a range of health-care providers to prescribe and to at least administer it. So we have doctors, nurses, nurse practitioners and even pharmacists can maybe pulled in to do this.
“In clinical trials lenacapavir was better, it was more effective than the daily pill taking. So it’s a wonder drug.”
Health Canada told Global News last week that though it is responsible for authorizing drugs and health products for safety, efficacy and quality, it is not responsible for its availability or distribution on the Canadian market, noting each province and territory has its own drug plan.
Gilead said it will work with payers in both the public and private space to “accelerate availability and access.”
Since the approval of the U.S. drug, there has been concerns over accessibility.
The U.S. list price, meaning before insurance, is US$28,218 a year, according to Gilead, which the company called similar to some other PrEP options.
O’Byrne said cost is a key factor in helping prevent HIV because while having such a drug is helpful, if certain populations are unable to access it, little progress can be made.
“We could get a lot of interest and if a lot of people can’t afford it, it’s dead in the water,” he said.
“I think the biggest thing that people say when we talk about PrEP, it’s how much does it cost. Some of that I think people are using the cost as, ‘I don’t really want to talk about it,’ but nonetheless it’s a huge barrier to say, ‘I can’t afford this.’”
According to the Public Health Agency of Canada, as of 2022 54 per cent of HIV-PrEP prescriptions were paid for by private insurance, while 43 per cent was paid by public coverage.
—with files from The Associated Press
© 2025 Global News, a division of Corus Entertainment Inc.
