Lenacapavir-a long-acting, six-monthly injectable antiretroviral medicine manufactured by Gilead Sciences-is now recommended by the World Health Organization as an additional HIV prevention choice as part of combination HIV prevention approaches.
Lenacapavir, a new pre-exposure prophylaxis (PrEP) medicine, has the potential to increase the uptake of PrEP and bolster HIV prevention overall as it allows people to choose a method that they prefer. Lenacapvir, administered twice a year, is highly effective at reducing the risk of HIV acquisition.
At a time when funding cuts could lead to an additional 6 million HIV infections and 4 million AIDS-related deaths by 2029, long-acting injectable medicines are a fresh option for all people at risk for HIV--especially those who face higher risk and in locations where the virus is highly prevalent: adolescent women and girls, LGBTQI+ people, sex workers and people who use drugs.
As Gilead has not yet registered Lenacapavir for regulatory approval in all countries, many people, including those facing disproportionate risk for HIV, may have to wait longer than others to access this life-saving tool.
Transparency in production costs and pricing strategies is fundamental to removing some market barriers to universal access to innovative products. UNAIDS remains committed to ensuring full transparency from originator pharmaceutical companies regarding how much health technologies cost to produce and at what level they are priced. Lenacapavir is no exception. Research shows that Lenacapavir can be produced at a thousand times less than its US price. Dozens of developing countries have been excluded from the licenses for generic Lenacapavir and for cabotegravir (another long-acting injectable antiretroviral for HIV manufactured by ViiV Healthcare).
The volume of Lenacapavir must be scaled up - but to do so, we need accessibility and affordable prices. Lenacapvir's limited availability and unaffordable price not only threatens lives, it also undermines the potential positive impact Lenacapavir could have on the AIDS pandemic. Significant funding cuts to foreign assistance for HIV have plunged the global response into crisis. In addition to viral suppression among people living with HIV, ensuring broad, rapid and affordable dissemination of this new health technology would hasten the decline of new HIV infection rates and would help limit the scope of the pandemic; essential, especially in a moment of constrained resources.
UNAIDS urges Gilead to swiftly register Lenacapavir for regulatory approval in all low- and middle-income countries - starting with those with the highest HIV incidence - and to ensure affordable access for everyone who could benefit, wherever they live. UNAIDS also encourages countries to prioritize prevention options that deliver impact and use simplified and differentiated delivery of prevention services to reach those in need.
There is no more time to waste. Governments, civil society, and the private sector need to take all steps necessary to enable equitable, global access to new health technologies for HIV such as Lenacapavir and Cabotegravir - and UNAIDS is here to support them.
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