Lenacapavir (Yeytuo) injected every six months approved for HIV prevention in Canada
June 4, 2026
CATIE News
- A long-acting injectable formulation of lenacapavir for HIV prevention was approved in Canada
- In clinical trials this drug was highly effective at significantly reducing the risk of HIV
- It proved superior to daily oral HIV prevention and was generally well tolerated in trials
A long-acting injectable formulation of the HIV drug lenacapavir developed for the prevention of HIV was approved in Canada. In well-designed clinical trials, long-acting lenacapavir was found to be highly effective (more than 99.9 per cent) at reducing the risk of HIV infection. Furthermore, this drug has been found to be superior to daily oral tenofovir DF + FTC (a combination sold as Truvada and available in generic formulations). One factor that may be driving this superiority is the reduced adherence requirements associated with injectable lenacapavir (two injections every six months versus daily pill taking).
Lenacapavir is manufactured by Gilead Sciences. The formulation of long-acting lenacapavir for HIV prevention is called Yeytuo in Canada and the European Union; it is called Yeztugo in the United States
HIV prevention – PrEP
When HIV drugs are used prior to exposure to prevent infection, this is called pre-exposure prophylaxis (PrEP). Yeytuo is the second long-acting formulation of PrEP that has been found to be highly effective. The first long-acting formulation of PrEP is sold as Apretude (cabotegravir) in Canada.
In Canada, Yeytuo has been approved for “at-risk adults and adolescents weighting 35 kg or more.”
Once Yeytuo injections become available in Canada, Gilead Sciences recommends that healthcare professionals counsel medically eligible patients about the importance of returning to their clinic for repeated dosing (every six months) and “discuss safer sex practices to reduce the risk of sexually transmitted infections.”
Before, during and after initiation of Yeytuo
HIV and STI testing
Yeytuo is meant for people who do not have HIV. Gilead Sciences recommends screening for HIV prior to initiating Yeytuo and “routinely thereafter as clinically appropriate while [patients] are receiving Yeytuo.” Also, Gilead notes that screening for sexually transmitted infections (STIs) prior to initiating Yeytuo “may be appropriate.”
Initiation
On the first day of initiation of Yeytuo, a healthcare provider injects two doses of lenacapavir solution into the patient’s abdomen, just under the skin. The patient also takes two tablets (300 mg each) of oral lenacapavir. The next day, the patient takes another two tablets of oral lenacapavir. Lenacapavir tablets can be taken with or without food. The purpose of the tablets is to quickly raise lenacapavir to protective levels in the blood.
Continuation
Twenty-six weeks after the first injection, the patient returns to their healthcare provider for another dose of injectable lenacapavir (two doses in their abdomen). Injections can take place within two weeks of this time.
Missed injections
If a scheduled injection visit is missed, Gilead Sciences advises healthcare providers that the patient “be clinically reassessed to ensure resumption of Yeytuo remains appropriate and that the individual remains HIV-1 negative.”
Missing injection appointments carries the risk that lenacapavir levels in the blood will fall below protective levels.
Gilead recommends that “if the scheduled six-month injection visit is anticipated to be delayed by more than two weeks, Yeytuo tablets may be used for oral bridging on an interim basis (up to six months if needed), until injections resume.”
This use of Yeytuo tablets helps maintain lenacapavir levels in the blood, but ultimately patients need to resume injections for protection from HIV.
Side effects
General side effects
In clinical trials with several thousand people, Yeytuo was well tolerated. Some participants (between 2 per cent and 7 per cent, depending on the study) reported headache as a side effect; this was usually mild to moderate and temporary.
Injection-related side effects
The most common side effects in clinical trials occurred at the site of injection of lenacapavir—76 per cent of participants reported this. These included one or more of the following:
- pain
- redness
- swelling
- bruising
- itching
- warmth
These side effects were usually temporary and mild to moderate.
The injections of Yeytuo form a small depot under the skin and are slowly released over months. Sometimes a small bump appears at the injection site; this is normal and eventually resolves. In some cases, people in clinical trials developed nodules at the injection site, which also eventually resolved. The nodules contain lenacapavir.
Lenacapavir as HIV treatment
A long-acting formulation of lenacapavir was also developed and approved for HIV treatment; it is sold as Sunlenca. When lenacapavir is used by people with HIV, it must be taken in combination with other anti-HIV drugs.
Access
Gilead Sciences is negotiating with private insurance formularies. Yeytuo should receive coverage from them later this year.
Canada’s provinces and territories as well as the federal government keep lists of drugs that they subsidize. These lists are called formularies. Gilead is negotiating with federal, provincial and territorial ministries of health about pricing for Yeytuo. If the government can afford the price, they will agree to subsidize the drug. Negotiations over drug pricing sometimes can be lengthy, taking a year or more, as cash-strapped governments seek a price that they can afford.
Your pharmacist will know when lenacapavir becomes available on your region’s formulary.
A CATIE fact sheet on Yeytuo is in development.
—Sean R. Hosein
REFERENCES:
- Gilead Sciences. Yeytuo—lenacapavir injection and tablets. Product Monograph. 9 April 2026.
- Kelley CF, Acevedo-Quiñones M, Agwu AL, et al. Twice-yearly lenacapavir for HIV prevention in men and gender-diverse persons. New England Journal of Medicine. 2025 Apr 3;392(13):1261-1276.
- Bekker LG, Das M, Abdool Karim Q, et al. Twice-yearly lenacapavir or daily F/TAF for HIV prevention in cisgender women. New England Journal of Medicine. 2024 Oct 3;391(13):1179-1192.
- Ogbuagu O, Segal-Maurer S, Ratanasuwan W, et al. Efficacy and safety of the novel capsid inhibitor lenacapavir to treat multidrug-resistant HIV: week 52 results of a phase 2/3 trial. Lancet HIV. 2023 Aug;10(8):e497-e505.
- Patel RR, Hoover KW, Lale A, et al. Clinical recommendation for the use of injectable lenacapavir as HIV preexposure prophylaxis – United States, 2025. Morbidity and Mortality Weekly Report. 2025 Sep 18;74(35):541-549.
- van Zyl G, Prochazka M, Schmidt HA, et al. Lenacapavir-associated drug resistance: implications for scaling up long-acting HIV pre-exposure prophylaxis. Lancet HIV. 2025 Oct;12(10):e732-e736.
From Canadian AIDS Treatment Information Exchange (CATIE).
This content was originally published by CATIE, Canada’s source for HIV and hepatitis C information.
Source: CATIE:
https://www.catie.ca/catie-news/lenacapavir-yeytuo-injected-every-six-months-approved-for-hiv-prevention-in-canada
For more information visit CATIE's Information Network at www.catie.ca
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