Unitaid NGO and Communities Delegations Celebrate Unitaid’s Success in Accelerating Affordable Access to Long-Acting Lenacapavir for PrEP

The NGO delegation to the Board of Unitaid, commends Unitaid’s leadership in accelerating access to quality-assured long-acting lenacapavir (LEN) to prevent the acquisition of HIV in 120 countries. Not only do Unitaid and its partners– Clinton Health Access Initiative (CHAI), Dr.Reddy’s, and Wits RHI– plan multiple interventions to bring lenacapavir pills and six-month injections to countries by early 2027, Dr. Reddy’s has agreed to do so at an affordable introductory price of $40 per person per year (plus, $17 for a starter pack of four pills when use of LEN-LA is initiated) with expectations that prices can decrease further in the future.

Simultaneously, the Gates Foundation announced a second initiative with another licensed generic company, Hetero Labs, to introduce lenacapavir at the same low price point. This entry price for lenacapavir is comparable to the price for oral pre-exposure prophylaxis (PrEP), but the every-six-month injectable has been found to be preferable for nearly 60% of users and almost 100% effective in preventing HIV infection.

Unitaid and its partners have planned and fine-tuned this initiative over the past several months with attention to issues such as lowering the cost of production, quantifying demand and supporting demand creation and community engagement, helping to accelerate WHO guideline development, facilitating rapid regulatory processes, and conducting implementation science studies.

On the back of this announcement, the delegations urge donors, governments, and global health initiatives to jump at the chance to invest quickly to provide community-preferred injectable pre-exposure prophylaxis (PrEP) to millions of people in Africa and elsewhere at risk of acquiring HIV. Donors like the US that have retreated from global health assistance, should increase – not decrease – HIV funding not only for long-act PrEP but also for test-and-treat programming that also has positive prevention effects. Donors, global health actors, and countries should immediately commit resources to bring the prevention promise of price reductions to life. Donors and governments should commit to ambitious plans to expand long-acting PrEP access far beyond the Global Fund/PEPFAR goal of 2 million people to the 10 million and eventually 20 million people at heightened risk of infection.

Countries should adopt WHO recommendations for long-acting PrEP in their national guidelines and include community-based self-testing, proper initiation, continuation, and restart of lenacapavir. They also need to train health professionals and ensure ready access to assured supplies of lenacapavir.

Although PrEP should be available to all, special efforts must be taken to reach high risk groups including young women in Africa and key populations – men-who-have-sex-with-men, transgender people, and people who use drugs. Given the decimation of the specialized community and NGO systems that have previously supported prevention, testing, and treatment programming for these marginalized and underserved populations, additional attention will be needed to resurrect what has been lost.

The news would be even better if Gilead would allow Dr. Reddy’s, Hetero Labs, and its other four licensees to supply the 26 middle-income countries and territories excluded from Gilead’s voluntary license so that millions of others could be affordably protected from HIV rather than having to pay Gilead’s secret and exorbitant tiered prices. Gilead should immediately commit to expanding its licensed territory to include all low and middle-income countries (LMICs) and to supplying them all with a transparent access price.

The NGO and Community Delegations to the Unitaid Board are proud of what Unitaid and its partners have achieved through hard work, deep collaboration, and smart interventions, but know it is just a promising start where ultimate success in fighting HIV will depend on donors, governments, and Gilead committing to scale-up and filling the regrettable gaps in access to affordable long-acting lenacapavir.