Update: Lenacapavir has received Health Canada approval for use as pre-exposure prophylaxis
Written by PAN’s Executive Director, J. Evin Jones on April 20th, 2026
On April 14th Gilead Sciences announced that YEYTUO™ (lenacapavir or LEN) has received Health Canada approval for use as pre-exposure prophylaxis (PrEP) for sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35kg.
The twice-yearly injection has been shown to reduce the risk of HIV transmission by more than 99.9 percent and is a potential game changer in the fight against HIV and AIDS both here in Canada and globally.
Gilead’s US list price for the medication is currently $28,218 a year. Various initiatives are underway including those led by PEPFAR and the Global Fund, as well as the Gates Foundation, Unitaid, and NIH, working with Gilead Sciences to provide generic versions of the drug for as low as US$40 a year in low and middle income countries.
With Health Canada approval having been secured, now the focus here in Canada must turn to access and equity, particularly for people who face challenges with stigma, access to care, and daily adherence. Gilead has been working on access pathways, and PAN will continue to track this issue and provide information as it comes available.
Original Post:
At the International AIDS Society Conference on HIV Science (IAS 2025) in Rwanda last week, there was excitement about lenacapavir, a drug that has proven highly effective as pre-exposure prophylaxis (PrEP) against HIV infection. Lenacapavir (LEN) is given every six months as an injection under the skin (subcutaneously), eliminates the need to remember to take pills, and has proven to be more effective than oral PrEP drugs. Last month, the US Food and Drug Administration (FDA) approved it for use to prevent HIV, and the release of new guidelines by the World Health Organization (WHO) at IAS 2025 recommending the use of LEN as an option for HIV prevention is seen by many as a gamechanger for the global HIV response.
Background
A quick look at the background studies on the drug helps to see why people are excited:
The Purpose I trial set out to look at the effectiveness of lenacapavir, an HIV capsid inhibitor, for HIV prevention in cisgender women. The study found that LEN was an excellent prevention option. In this article from CATIE, Sean Hosein breaks down the research into plain language.
Among many details, Hosein reports that the numbers of new HIV infections during the trial were distributed as follows:
lenacapavir – 0 infections among 2,134 participants
Truvada – 39 infections among 2,136 participants
Descovy – 16 infections among 1,068 participants
On top of preventing HIV acquisition, this article covering findings reported at IAS 2025 says that it is also “safe, well tolerated and effective for use during pregnancy and breastfeeding. Given its infrequent dosing, high efficacy and safety profile, it is now supported for use in pregnancy by both the US Food and Drug Administration (FDA) and the World Health Organization (WHO).”
Learn more about the Purpose 1 trial here.
The Purpose II study focused on additional populations: cisgender men, transgender women, transgender men, and gender nonbinary people who have sex with male partners. Lenacapavir again proved to be a good option for preventing HIV infection, with a 96% reduction in the risk of acquiring HIV among study participants, with 99.9% of individuals using LEN not acquiring HIV. Read the CATIE summary on study information here.
Inclusion is important
The PURPOSE clinical trials are reaching out to ensure that those who may benefit most from HIV prevention are represented. Beyond PURPOSE 1 and 2, they are now currently conducting:
PURPOSE 3 (a phase 2 study of lenacapavir for PrEP in Cisgender Adult Women being conducted in the United States) and
PURPOSE 4 (a phase 2 study of lenacapavir for PrEP among people who inject drugs being conducted in the United States).
And in the future:
PURPOSE 5 (a phase 2 study of lenacapavir for PrEP in people who would benefit from PrEP but are not currently taking PrEP. This study will be conducted in the United Kingdom and France) and
PURPOSE 365 (a phase 3 study of once-yearly lenacapavir, for PrEP in people who are recommended to take PrEP, including cisgender men, transgender women, transgender men, cisgender women, and nonbinary individuals who have sex with partners assigned male at birth. This study will be conducted in the United States).
Learn more about all of the PURPOSE studies here.
Moving hope forward
Given these successes, the World Health Organization released a statement July 14, 2025:
WHO recommends injectable lenacapavir for HIV prevention
“The World Health Organization (WHO) released today new guidelines recommending the use of injectable lenacapavir (LEN) twice a year as an additional pre-exposure prophylaxis (PrEP) option for HIV prevention, in a landmark policy action that could help reshape the global HIV response. The guidelines are being issued at the 13th International AIDS Society Conference (IAS 2025) on HIV Science, in Kigali, Rwanda… WHO urges governments, donors and global health partners to begin rolling out LEN immediately within national combination HIV prevention programmes – while collecting essential data on uptake, adherence and real-world impact.”
The United Nations has amplified WHO’s message:
WHO urges rollout of first long-acting HIV prevention jab
“WHO’s support for the injectable drug is significant because HIV prevention efforts are stagnating around the world. To make it easier for people to receive the injection close to home, the UN agency also recommends the use of rapid testing kits for the disease, as opposed to ‘complex, costly procedures’.”
As a CBC article on the potential impact of this development says, “Global efforts at ending the HIV pandemic by 2030 have stalled. There still are more than 30,000 new infections in the US each year and about 1.3 million worldwide.”
This use of LEN hasn’t been approved in Canada yet and pricing and funding for the drug domestically and internationally, will likely impact access, as has been the case for many new drugs for HIV prevention and treatment introduced over the years. Advocates for access see its life-saving potential, giving people another prevention option with the power to increase health equity and decrease stigma and discrimination. We will continue to follow this news and press for the care everyone deserves.
Questions? Reach out to J Evin Jones, Executive Director: [email protected]