On 18th June 2025, the US Food and Drug Administration (FDA) approved the use of long-acting antiretroviral medicine lenacapavir (LEN-LA), for the prevention of HIV, also known as pre-exposure prophylaxis (PrEP). It was previously approved as a treatment and oral LEN was available for the prevention of HIV. This new approval is significant because LEN-LA used in PrEP on a large enough scale has the potential to break the back of the HIV pandemic and end HIV. One injection of lenacapavir offers 6 months of protection, making it a truly transformative tool even in resource limited settings. In 2013, 1,3 million people acquired HIV.
Lenacapavir (LEN) is developed by Gilead Sciences. Data from the PURPOSE 1 clinical trial showed in June 2024 that LEN-LA was safe and effective in preventing HIV infection in 5300 HIV-negative women between the ages of 16 and 25 in Uganda and South Africa. Meaning no infections were seen among the trial participants who took the product. In September 2024, PURPOSE 2 trial, including 3200 participants, carried out in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States, showed similar results. For details, see: https://avac.org/resource/report/the-lens-on-len/
UNAIDS welcomed the trial results and urged Gilead to allow generic production of lenacapavir to all low- and middle-income countries by negotiating voluntary licensing agreements through the Medicines Patent Pool (MPP).
The MPP has flagged the product as one of interest and mapped the patent situation: LEN primary patents have been filed or granted in several low and middle-income countries (LMICs) and are expected to expire between 2034 and 2037. Gilead also holds secondary patents that may provide exclusivity until 2038 in many LMICs. Patent oppositions have been filed in several countries, including in India, Indonesia, Armenia, Belarus, Kazakhstan, Kyrgyzstan, Vietnam, Argentina and Thailand.
However, Gilead decided not to work with the MPP and, in October 2024, concluded bilateral licensing agreements with six generic manufacturers for the production and supply of LEN, allowing for sales for the treatment and prevention of HIV in 120 countries. Now the FDA has approves LEN-LA for PreP, licensees will be able to produce the product and supply it in the territories designated as eligible by Gilead. The licence excludes many countries in Latin America and Eastern Europe. It is unfortunate that Gilead did not collaborate with the MPP on its licensing strategies. For example, an MPP licence would have left the option open for supply by the generic licensee to countries outside the territory when there are no patent barriers, such as in the case of a compulsory license or if patents do not exist (including if one of the patent oppositions is successful). Health Gap published a useful brief on the patent issues related to LEN supply.
In July 2024, a study by Fortunak et al. showed that LEN’s cost-plus price for PrEP can be as low as US$35-US$40 per patient per year (pppy) provided it is produced at a large scale, which will decrease the cost of the active pharmaceutical ingredient. The authors conclude that ”mass-production of generic lenacapavir, under voluntary licensing, is required to achieve this.” A more recent estimate put the possible price at US$25 per injection once economies of scale are reached. The current list price for LEN used in HIV treatment is US$39,000 pppy. The New York Times reported that in the US, the list price for lenacapavir for PrEP, will be US$28,218.
Demand for the product will be key in creating economies of scale large enough to drive the price down to this level. And creating demand requires financing for procurement and supply. The dwindling global health financing and in particular the defunding of USAID and PEPFAR may therefore pose a serious threat to the uptake of the product and thus to the very real opportunity to end HIV.
Gilead is expected to publish its access strategy for LEN-LA when it obtains FDA approval. Collaboration with the MPP should be central in this strategy. Access to a product that has the potential to end HIV requires access to all and access everywhere.
Ellen ‘t Hoen, LLM PhD, is a lawyer and public health advocate with over 30 years of experience working on pharmaceutical and intellectual property policies.