WHO Endorses Twice-Yearly HIV Prevention Injection

The World Health Organization (WHO) is recommending a twice-yearly injection of lenacapavir for prevention of HIV, according to a press release. 

The injectable represents an additional option for people at risk, said Michelle Rodolph, a technical officer that the WHO, who presented the recommendations at the International AIDS Society Conference in Kigali, Rwanda.

Lenacapavir was approved by the FDA for HIV PrEP in June 2025, as noted by the WHO.

However, lenacapavir is not meant as a stand-alone prevention strategy, Rodolph emphasized in her presentation at the meeting. 

“The WHO is very firm that lenacapavir should be offered as an additional prevention choice alongside other HIV PrEP and prevention options,” she said. This does not mean that all other prevention options need be available, but choice is important, she said. Previous research has shown that PrEP uptake is greater when individuals are offered multiple options, she added. 

Some considerations and research gaps related to lenacapavir remain, she added. Provider training needs to increase, as does monitoring surveillance systems, and successful introduction depends on community participation, she said. The guidelines allow for lenacapavir use in women who are pregnant or breastfeeding, Rodolph noted.

The WHO also announced a new recommendation for rapid diagnostic testing. These tests may be used for HIV testing for initiation, continuation, and discontinuation of long-acting PrEP, Rodolph said. Although the recommendation is strong, the certainty of evidence is currently low, and the WHO will review emerging evidence when it becomes available and update guidance accordingly, she said. 

Meanwhile, the simplified testing recommendation improves access by facilitating delivery of long-acting PrEP in a variety of settings including clinics, pharmacies, and telehealth protocols, Rodolph said.