A significant clinical trial carried out in South Africa and Uganda has demonstrated, in a noteworthy breakthrough, that young women can be completely protected against HIV infection with a twice-yearly injection of a novel pre-exposure prophylaxis (PrEP) medication. Lenacapavir’s efficacy was evaluated in the Purpose 1 study by contrasting it with two other daily PrEP medications, Truvada (F/TDF) and Descovy (F/TAF).
What is Lenacapavir and How Does It Work?
Lenacapavir, also known as Len LA, is a fusion capsid inhibitor, a class of medication that interferes with the HIV capsid, a protein shell necessary for the virus to replicate. Lenacapavir is a more practical option than daily pills when it comes to young women who often struggle to stick to their drug regimes. It is administered merely under the skin once every six months.
The Purpose 1 Trial – Method and Results
The Purpose 1 trial involved 5,000 participants across three sites in Uganda and 25 sites in South Africa. The study, sponsored by Gilead Sciences, aimed to evaluate the safety and efficacy of Lenacapavir compared to the widely used daily PrEP pill Truvada (F/TDF) and the newer daily pill Descovy (F/TAF), which has better pharmacokinetic properties.
Participants, aged 16 to 25, were randomly assigned to one of three groups in a 2:2:1 ratio: Lenacapavir injection, F/TAF daily pill, or F/TDF daily pill. Neither the participants nor the researchers knew which treatment they were receiving until the trial concluded. This double-blinded approach ensured unbiased results.
Stunning Results
During the trial, none of the 2,134 women who received Lenacapavir contracted HIV, demonstrating 100% efficacy. In contrast, 16 of the 1,068 women (1.5%) on Truvada and 39 of the 2,136 women (1.8%) on Descovy contracted HIV. These results led an independent data safety monitoring board to recommend ending the trial’s blinded phase early, allowing all participants to choose their preferred PrEP.
The Impact on HIV Prevention
In eastern and southern Africa, young women are disproportionately affected by new HIV infections. Daily PrEP regimens can be challenging due to social and structural barriers. A twice-yearly injection like Lenacapavir could significantly improve adherence and reduce new infections among young women.
Globally, there were 1.3 million new HIV infections last year. Despite progress, we are not on track to meet the UNAIDS target of fewer than 500,000 new infections by 2025 or to end AIDS by 2030. Lenacapavir offers a promising new tool in the fight against HIV, particularly for those who struggle with daily medication.
Next Steps and Future Trials
The Purpose 1 trial will now continue in an open-label phase, where participants will be informed of their treatment group and can choose their preferred PrEP method. A sister trial, Purpose 2, is underway, focusing on cisgender men, transgender, and nonbinary individuals who have sex with men, to assess the drug’s effectiveness across different populations.
Gilead Sciences plans to submit the trial results to regulators in Uganda, South Africa, and other countries, with the World Health Organization also reviewing the data. The goal is to incorporate Lenacapavir into global and national HIV prevention guidelines.
Accessibility and Affordability
Getting Lenacapavir accessible is essential. With Gilead Sciences’ promise to grant licences to producers of generic medications, costs will be lowered and the medication will be easier to obtain in public health settings. Making this life-saving injection accessible to people who need it most will depend on affordable prices.
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