Twice-yearly shot prevents HIV in phase 3 trial, Gilead reports
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Key takeaways:
- There were no new HIV infections among study participants who received twice-yearly lenacapavir.
- Lenacapavir is already approved by the FDA for HIV treatment in patients with resistant infections.
Lenacapavir, an injectable antiretroviral drug approved by the FDA for HIV treatment, prevented 100% of new HIV infections among women in a phase 3 trial in Africa, demonstrating its efficacy as PrEP, Gilead Sciences said.
Topline results from an interim analysis of the phase 3 PURPOSE 1 trial — the first data Gilead has released from it — showed lenacapavir prevented HIV acquisition among all participants at 28 trial sites in South Africa and Uganda, Gilead reported in a press release.
Administered every 6 months, lenacapavir was approved by the FDA in 2022 as ART for adults with HIV infections that are resistant or intolerant to other therapies.
The new study, conducted among cisgender women and adolescents, suggests it may be an effective new PrEP option.
“This is one of the most important results we’ve seen to date in an HIV prevention study,” Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, said in a press release, noting that expanded choice for HIV prevention will help more people find the right option.
Another version of long-acting PrEP, administered every 2 months, is already approved in the U.S.
“Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most — from an easier-to-follow regimen for individuals to a decreased burden on the health care systems that are stretched to the limit,” Warren said.
The phase 3, double-blind, randomized study compared twice-yearly lenacapavir with Gilead’s once-daily oral PrEP medications — emtricitabine/tenofovir alafenamide fumarate (FTC/TAF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) — among more than 5,300 cisgender and adolescent girls aged 16 to 25 years in 25 sites in South Africa and three sites in Uganda, with participants randomly assigned in a 2:2:1 ratio among the three arms of the study.
Among 2,134 women in the lenacapavir group, there were no new cases of HIV infection, compared with 16 cases among 1,068 women in the FTC/TDF group (1.69 per 100 person-years) and 39 cases among 2,136 women in the FTC/TAF group (2.02 per 100 person-years), according to Gilead.
Studies have shown that PrEP medications are effective for cisgender women — although they have sometimes been left out of PrEP studies. Gilead and AVAC said the twice-yearly formulation may significantly increase their PrEP use.
A separate trial of lenacapavir, PURPOSE 2, is being conducted among cisgender men who have sex with men, transgender men, transgender women and gender nonbinary people in seven countries, with results expected in late 2024, Gilead said.
The said it plans to include results from both studies in its regulatory filings so that lenacapavir can be approved for multiple populations eligible for its use.
“Since oral PrEP was first shown to be safe and effective 14 years ago, the global health community has failed in delivering PrEP at scale and with equity — and we have, therefore, not see the impact that we need,” Warren said. “The lessons from the past are clear and we now must act on them and move with speed, scale and urgency. There can be no excuses moving forward.”
References:
- Gilead’s twice-yearly lenacapavir demonstrated 100% efficacy and superiority to daily Truvada for hiv prevention. https://www.gilead.com/news-and-press/press-room/press-releases/2024/6/gileads-twiceyearly-lenacapavir-demonstrated-100-efficacy-and-superiority-to-daily-truvada-for-hiv-prevention. Published June 20, 2024. Accessed June 20, 2024.
- Landmark trial in South Africa and Uganda finds twice yearly hiv prevention injection safe and highly effective. https://avac.org/press-release/twice-yearly-hiv-prevention-injection-safe-and-highly-effective/. Published June 20, 2024. Accessed June 20, 2024.
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