July 14, 2025 09:52 AM EDT R&DPharma
WHO adds Gilead’s twice-yearly injection to global PrEP guidelines
Kyle LaHucik
Biotech Correspondent
KIGALI, RWANDA — Weeks after the FDA’s watershed approval of Gilead’s twice-yearly HIV prevention injection, the World Health Organization recommended the product to further stop the spread of HIV.
The WHO on Monday added Gilead Sciences’ lenacapavir to its HIV PrEP guidelines as part of a highly anticipated announcement at the International AIDS Society Conference on HIV Science, taking place in Rwanda. The WHO’s presentation was over-attended, with more than 250 IAS attendees filtering into a second room to watch the livestream.
“While an HIV vaccine remains elusive, lenacapavir is the next best thing: a long-acting antiretroviral shown in trials to prevent almost all HIV infections among those at risk,” WHO Director-General Tedros Adhanom Ghebreyesus said in a press release.
The WHO’s decision arrives at a time when governments around the world are struggling to ramp up HIV prevention. The number of new HIV diagnoses worldwide remained stable from 2023 to 2024.
But the inclusion of lenacapavir, which is marketed in the US as Yeztugo, in the guidelines is particularly notable following the Trump Administration’s major funding cuts to government programs like PEPFAR, which has long provided resources to help implement treatment and prevention tools in more than 50 countries.
The World Health Organization presents its updated HIV guidelines at IAS 2025.
The WHO guidelines team first met to discuss lenacapavir for PrEP in January, Michelle Rodolph, a WHO technical officer on HIV prevention, said during the IAS presentation.
WHO isn’t the first organization to recommend the injection, but its global reach means its recommendation carries weight. The International Antiviral Society–USA Panel announced its support for lenacapavir PrEP in December, based on Phase 3 trial results presented earlier that year.
At the IAS conference, one of the field’s most prominent gatherings for HIV science, leaders hailed the importance of lenacapavir. But they also noted that innovation in PrEP must be coupled with new ways to get those therapies to the public, particularly in hard-to-reach areas. Giving people a choice in therapies is also key now that there are multiple PrEP injectables and pills to choose from.
Moupali Das
“This does not mean that all PrEP options need to be available. This is not feasible in all countries,” Rodolph said during her presentation. “What is important is choice because what we’ve seen through some data recently shown in South Africa is that when people have a choice of prevention options, there is a greater uptick of PrEP” use.
The guidelines for lenacapavir are a full-circle moment for Moupali Das, VP of clinical development and leader of Gilead’s HIV prevention trials.
The last time Das was in Kigali, in 2019, she and other Gilead executives met with a wide range of stakeholders, including community activists, trial investigators and ministries of health, to gather intel about how to design the pivotal PURPOSE trials for lenacapavir, Das said in an interview at IAS. This included discussions about enrolling pregnant and lactating people and younger populations.
Global reach
The global health authority’s decision came at breakneck speed compared to its past recommendations for other PrEP products like ViiV Healthcare’s cabotegravir and the daily pills that have been available for more than a decade.
Mitchell Warren
“We need to be pushing each other and holding each other accountable. We also have to celebrate the successes when we get them, because they come too rarely in our field,” said Mitchell Warren, executive director of the nonprofit AVAC, during an IAS session on Monday morning.
Two injections a year is a major departure from the every-other-month injectable from ViiV and daily pills. So far, it’s only been approved by the FDA. Gilead has forged agreements with six generic manufacturers and the Global Fund to eventually roll out the PrEP option in low- and middle-income countries.
Gilead said Monday that the European Medicines Agency is reviewing lenacapavir under an “accelerated assessment timeline,” which includes an application with “EU-Medicines for all.” That program allows the EU to work with regulatory bodies in low- and middle-income countries to assist in drug reviews.
“This will accelerate access because sometimes resource-limited nations have limited resources for regulatory approvals and review,” Das said.
The California biopharma has also submitted the shot for approval in Australia, Brazil, Canada, South Africa and Switzerland, and it expects to soon submit lenacapavir for approval in Argentina, Mexico and Peru.
More data from PURPOSE
Also at the conference on Monday, Gilead shared new data for lenacapavir, including in pregnant and lactating people, adolescents and people aged 16 to 25 years, from its Phase 3 PURPOSE-1 and PURPOSE-2 studies. Gilead initially revealed efficacy data from those trials last year, which was used to support the approval in the US.
“It was the most globally, racially, ethnically, age and gender diverse PrEP clinical trial program to date,” Das said. Pregnant and lactating people have long been excluded from studies of HIV prevention medicines, but this population faces increased risk of acquiring HIV.
In the PURPOSE-1 data, Gilead said Yeztugo was well tolerated by pregnant and lactating participants. The company said the safety profiles were similar between those who were pregnant and non-pregnant in the study. There were 509 pregnancies among 487 people, Gilead said. Das noted that some people in the study had multiple children, and some had twins.
“If you allow people to have reproductive choice, people want to get pregnant, especially our rural Ugandan populations, who are really interested in getting pregnant,” Das said. “That was a deterrent to enrolling in PrEP clinical trials in the past because you’d be required to use contraception.”
Gilead will begin a Phase 3 trial of a once-yearly form of lenacapavir later this year, Das said, and the company hopes to enroll a diverse patient population in that study as well.
AUTHOR
Kyle LaHucik
Biotech Correspondent
klahucik@endpointsnews.com
@ky_lahucik
