Lenacapavir’s Next Step: Turning Approval Into Access | IAS 2025

The FDA approval of lenacapavir as a long-acting, injectable form of preexposure prophylaxis (PrEP) is an important step forward in managing HIV infections globally. This can be achieved through equitable access, patient-centered delivery and affordability, according to a panel discussion called ‘Integrating LA PrEP: Lessons learned and conditions for access, presented today at the International AIDS Society (IAS) 2025 meeting in Kigali, Rwanda.

The success of lenacapavir starts with access, specifically for those who need it the most, such as female sex workers and men who have sex with men, according to Michelle Rodolph, M.S., M.P.H., a technical officer for Global HIV, Hepatitis and STI Programs at the World Health Organization (WHO). 

There are also variables in how lenacapavir will be distributed in each country, with Rodolph pointing out that some countries may use a community-based approach and others will use a facility-based approach.

“I want to emphasize we shouldn't be thinking about these as rules and regulations; we don't know how people are going to take lenacapavir,” Rodolph said. “People will take PrEP when they decide they need or want PrEP.”

The importance of choice is something Saiqa Mullick, M.B.B.Ch., M.P.H., Ph.D., director of implementation science, Wits RHI, echoed in her portion of the presentation.

“Women respond positively when they are shown different options, using visual tools and simple, relatable language—not clinical jargon,” Mullick said. “They value providers who take time to answer questions honestly and maintain privacy, but when counseling feels rushed, judgmental or confusing, it becomes a barrier.”

Mullick explained that demand for long-acting injectable PrEP is there, as demonstrated by the findings from Project PrEP, that when asked about their preferred method of PrEP, 65%of participants chose injectable cabotegravir, while 25% opted for oral PrEP and 2% opted for the dapivirine vaginal ring.

These PrEP counseling appointments also serve as an important integration point for other services such as contraceptive use and STI screening. Additional Project PrEP data showed that out of 3,000 women who chose a PrEP method during their appointment, 76% were either already using a contraceptive or received one during their visit.

“This tells us two things: first, that integrated services are happening, and second, same-day, same-place delivery of prevention and sexual and reproductive care is feasible and valued as we bring in these new products like lenacapavir,” Mullick said.

Cost has also been one of the major barriers to lenacapavir access, which can be reduced through the development of generics, according to Carolyn Amole, vice president of HIV, Hepatitis and TB at the Clinton Health Access Initiative, Inc.

“The only way for this product to live up to its potential and to reach the many millions at risk in low- and middle-income countries is to ensure it is brought to market as quickly and affordably as possible, Amole said during the presentation.

Amole discussed the work that’s being done to secure the development of lenacapavir generics. She also shared that her team is working with various donors and partners to ensure generic lenacapavir market availability by Q1 of 2027 at a price competitive with oral prep—a goal she called “extremely ambitious.”

“Much work will remain to support governments to determine how best to deliver this product at scale to those who need it most,” Amole said. “Over the past six months, we've seen a dismantling of many of the critical service delivery channels and infrastructure that support people at risk of HIV to access PrEP. We have our work cut out for us.”