A groundbreaking HIV-prevention drug, lenacapavir, which provides nearly complete protection with just two injections annually, is facing significant availability issues in regions where it is most critically needed. While the drug offers a promising alternative to daily pills and less frequent injections, a shortage of doses is hindering its rollout globally, particularly in East Africa.
In Mbarara, Uganda, a city with a high HIV prevalence, sex workers like Lisa Mutoni report difficulty in obtaining lenacapavir, often referred to as "lena." "They tell me that it is finished," Mutoni stated, highlighting the frustration for individuals seeking this long-acting prevention method. The drug's infrequent dosing is particularly beneficial for those who may struggle with daily medication adherence or have fluctuating locations.
Health experts emphasize that lenacapavir, developed by Gilead Sciences, has the potential to significantly impact the global HIV epidemic due to its extended efficacy. However, the current rate of its distribution is insufficient to meet the widespread demand. "The rate of growth (of lenacapavir rollout) isn’t fast enough. We need to be getting to the millions pretty soon," said Andrew Hill, an HIV treatment expert at the University of Liverpool.
A recent development offers a potential pathway to increased access: the tentative approval of a generic version of lenacapavir by the U.S. Food and Drug Administration. This generic version is anticipated to facilitate faster production and distribution to approximately 120 low-income countries at an estimated cost of $40 per year, a stark contrast to the U.S. list price of $28,218. The Global Fund aims to provide the drug to 3 million people by the end of 2028.
Despite these hopeful steps, some organizations, including Doctors Without Borders (MSF), argue that these targets are inadequate. MSF is urging Gilead to expedite the availability of affordable doses and to permit direct sales to the organization to accelerate distribution efforts. "Gilead says it wants to end the HIV epidemic ‘for everyone, everywhere,’ but its actions say otherwise," commented Melissa Barber, MSF USA global health advocacy and policy adviser.
Currently, individuals in Mbarara, where an estimated 10% of the adult population lives with HIV, are often relying on less effective prevention methods. Tarsisio Biryeija, a nursing officer at Mbarara Health Centre IV, noted that recent shipments of lenacapavir were quickly depleted. A batch of 40 doses in April, initially prioritized for pregnant mothers at risk, was followed by another 70 doses in June that were used up within 10 days, even after expanded eligibility criteria.
Uganda has made strides in reducing its HIV rate over the past three decades, but infections remain a concern, particularly driven by transactional sex. Lenacapavir's potential to curb transmission in such contexts is significant, yet its limited availability remains a critical barrier. Immaculate Nyamwija, founder of Action for Improved Health and Wealth in Mbarara, described the situation as challenging, with demand far exceeding the supply of the sought-after long-acting drug.