Lack of Lenacapavir PrEP Access Concerns HIV Advocates

The FDA approved lenacapavir as a form of twice-yearly injectable pre-exposure prophylaxis (PrEP) in June 2025. Its 96% effectiveness rate and $28,000 list price have since stirred controversy, causing advocacy experts to worry about access.

“[Pharmaceutical companies] will usually point to patient assistance programs as being a way of getting around that, but the fact of the matter is that when you're trying to get something that's the price of a car out into the system, the system treats it like something as expensive as a car,” Jeremiah Johnson, the executive director of PrEP4All, said in a July 2025 interview with Managed Healthcare Executive.

Approved in 2021, Apretude (cabotegravir) was the first-ever FDA-approved injectable form of PrEP, to be given every two months. However, uptake has been slow, which can be attributed to cost, lack of awareness, and clinic shortages. As of March 2024, in the United States, only 1.4% of the total patients on PrEP were on cabotegravir.

“Because cabotegravir never really took off, and then the cabotegravir orders earlier this year got canceled from PEPFAR to ViiV, we are really kind of still starting from scratch and building a program to deliver an injectable,” Mitchell Warren, the executive director of the AIDS Vaccine and Advocacy Coalition (AVAC), said in a separate July Managed Healthcare Executive interview. “We need to use the next two to three years to build it with scale to drive the price down so that when multiple generics get to the market in 2027 or 2028, we are not just saving money, but more importantly, we are preventing massive numbers of infections.”