Global regulatory collaboration for the assessment of lenacapavir as a long-acting pre-exposure prophylaxis against HIV infection

The availability of long-acting pre-exposure prophylaxis (PrEP) to prevent HIV infection will be essential for disease control. Despite significant improvements in prevention strategies, the global HIV population was estimated to increase by 1.3 million in 2024, with Africa accounting for nearly half of all new carriers (1). Although PrEP has been recommended since 2015 by the World Health Organization (WHO) for people at an increased risk of infection (2), uptake has been limited, and adherence is frequently inadequate. Daily oral PrEP is safe and effective in preventing HIV, particularly amongst men who have sex with men (MSM), serodiscordant couples, and people who inject drugs (PWIDs) (3). In addition, event-driven (on-demand) oral PrEP has been shown to be as effective as a daily dose amongst MSM in Europe (4). Notably, the efficacy was strongly associated with the levels of adherence. It is estimated that less than 30% of people who start using daily oral PrEP receive the HIV protective benefit of PrEP within 6 months of initiation due to discontinuation or poor adherence (5). Oral PrEP discontinuation rates are highest in sub-Saharan Africa, which has the greatest HIV-1 burden (5).