In a groundbreaking clinical trial conducted in South Africa and Uganda, a new pre-exposure prophylaxis (PrEP) drug has demonstrated total protection against HIV infection for young women. The trial, known as Purpose 1, tested the efficacy of a twice-yearly injection of lenacapavir (Len LA) compared to two daily oral PrEP drugs, Truvada (F/TDF) and Descovy (F/TAF).
Lenacapavir’s remarkable results
According to Physician-scientist Linda-Gail Bekker, principal investigator for the South African part of the study, the trial, involving 5,000 participants across 28 sites, revealed that none of the 2,134 women who received lenacapavir contracted HIV, showcasing 100% efficacy. In comparison, 16 of the 1,068 women taking Truvada and 39 of the 2,136 women on Descovy contracted the virus.
Lenacapavir, a fusion capsid inhibitor, works by interfering with the HIV capsid, a protein shell that protects the virus’s genetic material. This innovative drug is administered via injection once every six months, offering a significant advantage over daily pills.
A major breakthrough for HIV prevention
Dr. Linda-Gail Bekker, emphasized the significance of this breakthrough. “This breakthrough gives great hope that we have a proven, highly effective prevention tool to protect people from HIV,” she stated.
The study’s results are particularly impactful for young women in eastern and southern Africa, a demographic that bears the brunt of new HIV infections. Daily PrEP regimens have been challenging to maintain due to various social and structural barriers. A biannual injection could significantly ease this burden, improving adherence and protection.
Next steps and future prospects
Following these promising results, the Purpose 1 trial will continue in an “open label” phase. A sister trial, Purpose 2, is also underway, targeting cisgender men, transgender, and nonbinary individuals who have sex with men across various regions, including some sites in Africa.
Gilead Sciences plans to submit the trial results to regulators in Uganda, South Africa, and the World Health Organization (WHO) within the next few months. The aim is to integrate lenacapavir into WHO and national guidelines, ensuring widespread access and affordability, particularly through licensing agreements with generic manufacturers.
A new hope for ending HIV infections
This breakthrough is a vital step towards reducing the global HIV infection rate. Despite the availability of various prevention tools, young people face challenges in consistent use. Lenacapavir’s biannual injection could simplify prevention, making it more accessible and reducing new infections, especially among vulnerable populations.
As the global community strives to meet UNAIDS’ target of fewer than 500,000 new infections by 2025 and the goal to end AIDS by 2030, lenacapavir offers a beacon of hope for a future free from HIV.
(With inputs from The Conversation)