A groundbreaking study published in the New England Journal of Medicine has revealed that twice-yearly injections of lenacapavir, an antiretroviral drug, are over 96% effective in preventing HIV infection. The study demonstrates lenacapavir’s potential as a transformative pre-exposure prophylaxis (PrEP) option, outperforming the widely used daily oral medication emtricitabine–tenofovir disoproxil fumarate (F/TDF), marketed as Truvada.
The phase 3, double-blind, randomized trial involved 3,265 participants from diverse backgrounds, including cisgender men, transgender individuals, and nonbinary participants. The study focused on individuals at high risk of HIV infection. Participants were randomly assigned to receive either lenacapavir injections every six months with a daily oral placebo or daily oral Truvada with a placebo injection.
Results showed that only two participants in the lenacapavir group contracted HIV, compared to nine in the F/TDF group. This translates to a 96% reduction in HIV risk compared to the background incidence rate. Researchers also noted that adherence to lenacapavir injections was significantly higher than adherence to daily oral medication.
Dr. Moupali Das, Vice President of Clinical Development at Gilead Sciences, emphasized the significance of the findings, stating, “Lenacapavir demonstrated a 99.9% prevention rate among participants and was 89% more effective than once-daily Truvada.”
The study faced some challenges, including a temporary five-month hold on lenacapavir injections by the FDA, during which participants were switched to alternate regimens. Researchers also noted potential limitations in the inclusion criteria and data on background HIV incidence.
Despite these challenges, no safety concerns were identified, although two participants in the lenacapavir group who contracted HIV showed signs of drug resistance, warranting further investigation.
Experts view lenacapavir as a game-changer in HIV prevention. Dr. Charles Flexner of Johns Hopkins University likened its effectiveness to that of a vaccine, though he cautioned that access and affordability remain key barriers, particularly in low- and middle-income countries where HIV infections are most prevalent.
James Cole, Senior Policy Manager at the National AIDS Trust in the U.K., highlighted lenacapavir’s potential to overcome stigma and adherence challenges in underserved communities, calling it “an innovative and discreet option” that aligns with global HIV prevention goals, including UNAIDS’ 2030 targets.
As reported by medicalnewstoday, while lenacapavir is currently approved for treating multidrug-resistant HIV, broader regulatory approval will be required to make it widely available as a PrEP option. Researchers remain optimistic, with ongoing studies evaluating lenacapavir’s use in additional populations and geographies.