Gilead unveils more positive data on HIV prevention shot

Promising findings from Gilead Sciences’ trial with adolescent girls and young women who were given twice-yearly PrEP injections using the antiretroviral drug lenacapavir mean this new form of PrEP could become a gamechanger for HIV prevention efforts.

What is this research about?

These are the first findings from Phase 3 of Gilead’s PURPOSE 1 trial. The trial compared the efficacy of twice-yearly PrEP injections to once-daily PrEP pills in HIV prevention among cisgender adolescent girls and young women. The study involved 5,300 cisgender young women and adolescent girls (aged 16-25) in South Africa and Uganda. Participants were split into three groups. One group received lenacapavir PrEP injections twice a year. The other two groups received a different type of daily PrEP pill each.

Why is it important?

PrEP stops HIV-negative people getting HIV. It normally comes in pill form, but many people struggle to take PrEP pills every day and get refills. Research is now being conducted on PrEP injections and PrEP vaginal rings which provide protection for longer. Options like these could improve adherence and accessibility, which reduces risk of getting HIV.

The most advanced research on PrEP injections so far is on the antiretroviral cabotegravir. This requires an injection once every two months. A number of countries have approved cabotegravir injections, which are likely to become the first type of injectable PrEP that is widely available.

Lenacapavir injections last even longer, with one shot needed every six months. Research is further behind than cabotegravir. But promising findings from PURPOSE mean twice-yearly PrEP injections could one day become available.

What are the research findings?

In the trial, women in the lenacapavir group had 100% adherence to twice-yearly injections. No women in this group contracted HIV. In comparison, HIV incidence among adolescent girls and young women not using any type of PrEP in the study locations was 2.41 per 100 people. This was similar to HIV incidence among trial participants taking either of the daily PrEP pills.

All three PrEP options had minimal side effects and were safe to use.

The PURPOSE programme consists of five lenacapavir PrEP trials. Results from other PURPOSE trials in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the USA are expected this year (2025). These trials involve cisgender men who have sex with men, transgender men, transgender women and non-binary people who have sex with men.

What does it mean for HIV services?

Following the PURPOSE 1 results, this month [February 2025] the US Food and Drug Administration (FDA) accepted Gilead’s application to approve lenacapavir PrEP injections. If the FDA gives regulatory approval for twice-yearly PrEP, other countries are likely to follow.

In time, this could provide cisgender adolescent girls and young women, and other people at high risk of HIV with the most convenient PrEP option yet.

Linda-Gail Bekker, Director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, said: “Twice-yearly lenacapavir for PrEP, if approved, could provide a critical new choice for HIV prevention that fits into the lives of many people who could benefit from PrEP around the world – especially cisgender women.”

If you are working on sexual health, it is important to understand which HIV prevention options are available, which options may become available, and where to get them from in order to provide your clients with the best options for them.

Accurate information is key, and Be in the Know has you covered. Visit our HIV prevention section for more.