The World Health Organization (WHO) has recently expressed its enthusiasm regarding the promising results from the PURPOSE-2 trial, which focuses on the long-acting injectable lenacapavir (LEN) for HIV prevention. An interim analysis released on September 12, 2024, highlights the drug’s impressive efficacy in preventing HIV transmission.
Lenacapavir, an HIV-1 capsid inhibitor administered through subcutaneous injection every six months, has shown significant effectiveness in preventing HIV among various populations, including cisgender men, transgender men, transgender women, and gender non-binary individuals who engage in sexual activity with partners assigned male at birth.
The findings from the PURPOSE-2 trial are particularly noteworthy, showcasing a remarkable 96% reduction in the risk of acquiring HIV among participants. A staggering 99.9% of individuals receiving LEN did not contract HIV during the study. Out of 2,180 participants who received the biannual LEN injections, only two new HIV cases were reported. In contrast, nine new cases emerged among 1,087 participants who were on the daily oral regimen of TDF/FTC (tenofovir disoproxil fumarate/emtricitabine).
These results indicate that lenacapavir not only reduces HIV incidence by 96% compared to background rates but also outperforms daily oral TDF/FTC by 89% in preventing HIV acquisition. Both LEN and the daily oral medication were reported to be well tolerated by participants, with no significant or new safety concerns arising during the trial.
These latest findings build on the earlier results from the PURPOSE-1 trial, where lenacapavir demonstrated its efficacy in preventing HIV among cisgender women in sub-Saharan Africa, with zero reported infections among women receiving the injectable treatment.
Collectively, the results from both the PURPOSE-1 and PURPOSE-2 trials present compelling evidence for lenacapavir’s potential to revolutionize HIV prevention strategies worldwide, catering to diverse populations. While oral pre-exposure prophylaxis (PrEP) remains a safe and effective option when taken as prescribed, LEN’s biannual dosing schedule offers a significant advantage for individuals who may struggle with the adherence required for daily oral PrEP. This includes challenges such as stigma, discrimination, pill fatigue, and inconsistent access to medications.
Looking ahead, the WHO is eagerly anticipating the full publication of the PURPOSE-2 trial findings, which will undergo a thorough scientific peer review process. In the meantime, WHO is actively working to assemble a guideline development group that will include experts, ministries, partners, and community representatives. This group will be tasked with developing and issuing guidelines based on a comprehensive assessment of lenacapavir’s potential for HIV prevention. Key areas of focus will include evaluating efficacy, safety, cost-effectiveness, stakeholder values and preferences, as well as the global scalability of the treatment.
Simultaneously, the WHO is collaborating with international partners, pharmaceutical companies, and generic manufacturers to create a supportive environment for the implementation of lenacapavir as a preventive measure against HIV. The goal is to ensure that this innovative treatment can be accessible and effective for those at risk of HIV, ultimately contributing to the global fight against the epidemic.
The ongoing research and development surrounding lenacapavir signal a significant step forward in HIV prevention, offering hope for improved health outcomes and a reduction in new infections across various demographics. As the WHO and its partners continue to evaluate and promote this groundbreaking treatment, the focus remains on enhancing the lives of individuals at risk of HIV and addressing the broader public health challenges posed by the virus.
