GNV News 2025 June 22

2025 June 18, the U.S. Food and Drug Administration (FDA) HIV prevention injectable drug “lenacapavir” and officially approved. In contrast to oral pre-exposure prophylaxis (PrEP), which requires daily dosing, lenacapavir is given every six months and requires only one injection. Therefore, it can overcome various prevention barriers such as the burden of daily dosing, missed pills, and frequent clinic visits; and because it has very high preventive efficacy, it has been hailed as a breakthrough therapy. Worldwide, the number of people living with HIV as of 2023 is estimated at 39.9 million, and 1.3 million people newly acquired HIV in that year. The approval in the United States is expected to spur global endorsement by the World Health Organization (WHO), raising expectations for progress from the current situation.

At the same time, approval by national regulatory authorities does not necessarily mean this product will be immediately available. Gilead Sciences announced a U.S. list price for lenacapavir of per person per year of $28,218 U.S. dollars. However, according to a research paper in The Lancet, the cost of generic lenacapavir could be per person $35–$46 per person, and suggests it could be reduced to one year of introduction to $25 U.S. dollars. The Joint United Nations Programme on HIV/AIDS (UNAIDS) has made a request to Gilead to lower the price so that people can access this medicine quickly and equitably at an affordable price.

In 2024 October, Gilead, regarding access to lenacapavir, “HIV high burden and limited resources” 120 countries, signed agreements with six licensing agreements and announced that until the contracted generics are able to begin supplying the medicine, it would supply these countries at cost. However, countries such as Brazil, Colombia, and Mexico—where the incidence is high but incomes are relatively higher—are excluded from these agreements. In addition, because the international organization that brokers licenses for new medicines, the Medicines Patent Pool (MPP) is not involved, the transparency of the distribution mechanism has also been called into question.

Learn more about past HIV/AIDS responses → “The evolution of HIV/AIDS responses in Africa”

Learn more about disparities in health care → “Global disparities in access to medicines: profit or lives?”

Learn more about Japanese media coverage through the lens of the pandemic treaty → “Pandemic treaty: Did the media convey the lessons of COVID-19?”

Photo: HIV testing (UNICEF Ethiopia / Flickr [CC BY-NC-ND 2.0] )