GENEVA, 10 July 2024— UNAIDS has welcomed the release of Gilead Sciences’ trial results on the injectable long-acting HIV medicine Lenacapavir for HIV prevention. The result “provides hope of accelerating efforts to end AIDS”, UNAIDS says, “but only if Gilead ensures that all people who need it can have access to this game-changing medicine.”
The recent trial of the medicine among cis-gender women in Uganda and South Africa was so successful that it was halted early. Twice-yearly injections of Lenacapavir showed overwhelming efficacy for preventing HIV infections compared to standard oral preventative HIV medicines, known as pre-exposure prophylaxis (PrEP). Additional trials are ongoing in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.
UNAIDS has welcomed the “exciting development,” and urged the company 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 is a UN-backed programme with extensive experience negotiating generics agreements between originators and generic pharmaceutical companies.
Gilead has not yet announced its plans for low and middle-income countries. However, UNAIDS is concerned that Gilead’s latest statement regarding its access strategy for low and middle-income countries mentions only “high incidence countries and resource limited countries” and makes no specific mention of upper-middle-income countries or the Medicines Patent Pool. Upper middle-income countries account for 41% of new HIV infections and 37% of all people living with HIV. These countries are home to millions who cannot afford the prices Gilead charges high-income countries.
“The success of Gilead’s recent Lenacapavir trial is an exciting development. While we still await regulatory approvals, normative guidance and results from the other ongoing trials, this news offers hope that we can enable everyone who would benefit, including especially the most marginalised communities, to have access to the help they need. Enabling equitable global access to new technologies can help get the world on track to end AIDS as a public health threat by 2030,” said Winnie Byanyima, Executive Director of UNAIDS. "However, it is concerning that Gilead’s latest announcement seems to mention neither upper-middle income countries, where people cannot afford anything like Lenacapavir’s current $42,250 price tag, nor a commitment to work with the UN-backed Medicines Patent Pool. Without these safeguards, it cannot be assured that this game-changing medicine will reach all those who need it."
Notes
Data in this press release comes from UNAIDS 2023 Epidemiological estimates (aidsinfo.unaids.org)
The UNAIDS Executive Director joined more than 300 experts and activists calling for a generic version of Lenacapavir to be licensed to all low and middle-income countries through the MPP, in a letter coordinated by the People’s Medicines Alliance: https://peoplesmedicines.org/wp-content/uploads/2024/05/Gilead-Open-Letter_May-2024.pdf
The AIDS Vaccine Advocacy Coalition provides an overview of the Lenacapavir for PrEP trials: https://avac.org/resource/infographic/an-overview-of-lenacapavir-for-prep-trials/
UNAIDS
The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.
