SAMRC Welcomes the Approval of Lenacapavir as A Landmark in HIV Prevention

The South African Medical Research Council (SAMRC) welcomes the announcement by the South African Health Products Regulatory Authority (SAHPRA) that it has approved the registration of Lenacapavir, a groundbreaking antiviral medicine recommended, alongside safer sex practices, for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection in adults and adolescents weighing at least 35 kg.

This milestone marks a significant advancement in South Africa’s ongoing efforts to curb new HIV infections, particularly among young women and adolescent girls who remain at heightened risk.

The SAMRC, through its HIV and Other Infectious Diseases Research Unit (HIDRU), played a pivotal role during the clinical trial phase. Five SAMRC clinical trial sites across South Africa participated in the PURPOSE 1 study, a large international multicentre trial assessing the safety and efficacy of twice-yearly, subcutaneous Lenacapavir for HIV prevention, alongside the daily oral regimen Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg; F/TAF).

More than 5,300 cisgender women and adolescent girls aged 16–25 years took part across 25 South African and three Ugandan sites, with the SAMRC’s HIDRU sites contributing 13% of participants to the efficacy results. The study demonstrated a 100% efficacy rate in preventing HIV infection among participants receiving Lenacapavir.

This achievement directly aligns with the SAMRC’s mandate to advance health through scientific research, innovation, and the translation of discoveries into health solutions that improve lives. By contributing to the generation of high-quality evidence that informs public health policy and clinical practice, the SAMRC continues to play a central role in shaping the future of HIV prevention in South Africa and beyond.

The SAMRC extends its gratitude to the study volunteers, research teams, community stakeholders, and collaborating partners whose commitment and participation made this success possible. Their collective contribution reinforces the importance of community engagement in health research and demonstrates the impact of collaborative science in addressing South Africa’s most pressing health challenges.

With the approval of Lenacapavir, South Africa moves closer to realising a future where individuals have greater choice and empowerment in HIV prevention.

For more information, please contact:

Yolanda Phakela
SAMRC Public Relations Manager
Yolanda.phakela@mrc.ac.za