Major breakthrough in HIV prevention: Biannual injection proves 100% effective
What's the story
A significant advancement in HIV prevention has been found in a large clinical trial conducted in South Africa and Uganda. The trial demonstrated that lenacapavir, a new pre-exposure prophylaxis (PrEP) drug administered twice yearly, offers complete protection from HIV infection in young women. This trial aimed to test the efficacy of lenacapavir against two other daily pill medications, both also PrEP drugs.
Drug efficacy
Lenacapavir: A new hope in HIV prevention
The Purpose 1 trial involved 5,000 participants across three sites in Uganda and 25 sites in South Africa. The drug lenacapavir, a fusion capsid inhibitor, works by interfering with the HIV capsid, a protein shell that protects the virus' genetic material and enzymes necessary for replication. Administered subcutaneously every six months, it demonstrated complete protection against HIV infection among young women during the trial.
Comparative efficacy
Trial results: Lenacapavir outperforms other PrEP drugs
During the randomized phase of the trial, none of the 2,134 women who received lenacapavir contracted HIV, demonstrating 100% efficiency. In contrast, 16 out of 1,068 women who took Truvada (F/TDF) and 39 out of 2,136 who received Descovy (F/TAF) contracted HIV. These results led to a recommendation by an independent data safety monitoring board review that the trial's "blinded" phase should be stopped.
Future prospects
Lenacapavir: A potential game-changer in HIV prevention
The breakthrough offers hope for a highly effective prevention tool against HIV, especially considering the 1.3 million new HIV infections globally in the past year. The twice-yearly injection could reduce unpredictability and barriers associated with daily prevention decisions. The Purpose 1 trial will now proceed in an "open label" phase, where participants will be informed about their group assignments and offered their preferred choice of PrEP as the trial continues.
Regulatory submission
Gilead Sciences to submit trial results for regulatory review
Gilead Sciences, the sponsor of the trial, plans to submit the results to Ugandan and South African regulators within the next few months. The World Health Organization (WHO) will also review the data and may issue recommendations. Furthermore, Gilead has expressed its intention to offer licenses to generic drug manufacturers to ensure affordable access and distribution in the public sector.