The two-year shot to prevent HIV from being called “Wonder Drugs” could soon come to Canada next year, but the company behind it says it could still take some time for the general population to access it.
Gilead Canada confirmed with Global News this April that it submitted Lenacapavil for its use of pre-exposure prophylaxis (PREP) as a new injectable drug to Health Canada, and was accepted by the institution for review this month.
It said it expects the drug evaluation to be completed in mid-2026.
Global News asked Health Canada about potential approval times and timelines for approval processes.
Canadian health professionals and HIV prevention advocates say Gilead drugs are “monopoly advances.”
“This is definitely a monumental advancement in prevention,” said Peter Newman, professor of social work at the University of Toronto.
“These kinds of things can really help get it out there faster and are certainly cost-effective in the long run, as it prevents many new cases of HIV.”
The drug is a groundbreaking study of people at higher risk than daily preventative drugs that people can forget to take, almost eliminating new infections and prompted the U.S. Food and Drug Administration to approve it in the country last week.
Condoms can help prevent HIV infection when used properly, but what is called PREP is becoming increasingly important with the regular use of preventive medications such as daily tablets and shots given every two months.
With six months of protection from Lenacapavir, it is the longest-lasting type. This is an option that may attract people who are wary of more frequent doctor visits and stigma from daily pills.
Renacapavil was originally approved by Health Canada in 2022 as both an injection and tablet for the treatment of HIV, but prevention was permitted, while prevention was permitted.
The injection is given as two doses under the skin of the abdomen, leaving a small “depot” of medication for slow absorption into the body.
Patrick O'Byrne, a nurse practitioner at STI Clinic in Ottawa, said unlike tablets that can forget the dose, injections are not easy to forget.
Get weekly health news
Receive the latest medical news and health information provided every Sunday.
“It's hard to ruin that. You can get the injection and it works,” Obirn said. “Injections are much more tolerant, so in practice, studies show that they have less dependence on people, which results in better prevention results.”
Gilead must test for HIV negativity before getting two doses a year.
There are more videos in Canada
Just like oral preparation, this drug not only prevents the transmission of HIV, but is not another sexually transmitted disease.
According to Gilead, if approved, two shots per year must be managed by a healthcare worker, namely a doctor or nurse.
But some supporters say it should be extended.
“We only have two shots a year, which reduces patients spending time in the waiting room,” says Sean Hossain, editor of Science and Drugs for Canadian AIDS Treatment Information Exchange, known as Catie, which is funded by federal and provincial grants.
Trend now
145 and 12 people were arrested stabbed with syringes at the French Music Festival
Ezra Miller “remorrows” of his past actions, suggesting he will return to Hollywood
“But I think another way to make prevention more widely available is to allow various healthcare providers to prescribe and at least manage it. So doctors, nurses, nurses, and even pharmacists can do this.
“In clinical trials, lenacapavir was excellent. It was more effective than taking the pill daily. So it's a strange drug.”
Health Canada last week told Global News that it is responsible for approving drugs and health products for safety, efficacy and quality, but is not responsible for availability or distribution in the Canadian market.
Gilead said it will work with payers in both public and private spaces to “accelerate availability and access.”
Since approval of the US drug, accessibility has been concerns.
According to Gilead, the pre-insurance US price is $28,218 per year.
O'Byrne said that while carrying such a drug, it is a key factor that can help prevent HIV as little progress can be made if a particular population has no access to it.
“We can get a lot of interest and if a lot of people can't afford it, it's dying underwater,” he said.
“I think that's the biggest thing people say when talking about Prep. That's how much it costs. I think part of it is saying, 'I really don't want to talk about it,' but even so, saying 'I can't afford this' is a big barrier. ”
According to the Canadian Public Health Agency, as of 2022, 54% of HIV-Prep prescriptions were paid through private insurance, and 43% were paid through public coverage.
– Includes files from Associated Press
&Copy 2025 Global News, a division of Corus Entertainment Inc.