Every week 4,000 adolescent girls and young women aged 15–24 years became infected with HIV according to UNAIDS, with most of these infections occurring in sub-Saharan Africa. Stigma and lack of access to care in limited resource settings are a major driver of new HIV infections, which disproportionately impact people who are marginalized by society such as young girls, injection drugs users and men who have sex with men.
A groundbreaking advancement in HIV prevention and treatment has emerged with the development of lenacapavir, a long-acting injectable for the treatment of HIV which was recently shown to be highly effective as pre-exposure prophylaxis (PrEP) among cisgender women. In a recently completed phase three trial, PURPOSE-2, lenacapavir demonstrated a 96 percent relative risk reduction from baseline HIV incidence and was 89 percent more effective than once-daily oral PrEP.
The potential impact of lenacapavir is vast. With its long-acting formulation, individuals will only need to receive injections twice a year, drastically reducing the burden of daily medication and increasing adherence, which is often a challenge for many at risk of HIV.
These findings build on research from Monica Gandhi, MD, MPH, professor of medicine at UCSF and director of the UCSF Center for AIDS Research. Gandhi has been championing the use of lenacapavir both as an HIV prevention and treatment, recently calling for broader clinical trials based on the drug’s efficacy in HIV treatment when combined with the antiretroviral cabotegravir.
“A twice-yearly injection to prevent or treat HIV will be a major breakthrough, but we must work hard in the HIV world to ensure access to high-burden settings,” Gandhi said.
Gilead Heeds Call to Democratize Global Access
Gilead, manufacturer of lenacapavir, listened to global health professionals who were concerned that this life saving intervention would be priced out of reach for low resource settings where the burden of HIV disease is highest. On October 2, the company decided to grant royalty-free licenses to six generic drug manufacturers, an important milestone in ensuring that lenacapavir reaches those in need in low- and middle-income countries.
These agreements will enable the production of affordable versions of lenacapavir in 120 countries including India, Ukraine and the Philippines, and in high-incidence regions such as Tanzania, Uganda and Kenya. This development addresses a key barrier for populations facing challenges with daily oral PrEP adherence due to stigma or lifestyle constraints.
“This Gilead announcement is a promising sign,” Gandhi said, “but we have to watch carefully how this is executed.”
Notably, Gilead’s agreement did not specify that lenacapavir must only be used for HIV prevention — leaving the door open for a long-lasting treatment option as demonstrated by Gandhi’s previous work.
“Lenacapavir offers hope for individuals who have struggled with adherence. Gilead’s commitment to licensing generics is a critical step toward making this innovation accessible to the populations who need it most, particularly in high-incidence, low-resource settings,” said Eric Goosby, MD, professor of medicine at UCSF, former US AIDS Coordinator under the Obama administration and founding director of the Office of Global Health Diplomacy in Secretary Clinton’s Office.
UCSF’s deep commitment to both scientific innovation and implementation ensures that breakthroughs like lenacapavir don’t just remain in labs but are rolled out to communities in need across the globe. Through global training programs and its emphasis on implementation science, UCSF continues to play a critical role in fighting the HIV epidemic, supporting advocacy for and the rollout of life-saving treatments to the populations who stand to benefit the most.