Clinical Trial Success in South Africa and Uganda
A large clinical trial in South Africa and Uganda has revealed that a twice-yearly injection of the new pre-exposure prophylaxis drug, lenacapavir, provides complete protection against HIV infection for young women. This groundbreaking study tested lenacapavir against two other daily PrEP pills, demonstrating its superior efficacy.
Study details and results
Physician-scientist Linda-Gail Bekker, the principal investigator in South Africa, discussed the Purpose 1 trial involving 5,000 participants across 28 sites. Lenacapavir, a fusion capsid inhibitor, was administered biannually. The study aimed to compare its effectiveness and safety with Truvada (F/TDF) and Descovy (F/TAF), both daily oral PrEP drugs.
The trial, sponsored by Gilead Sciences, found that none of the 2,134 women who received lenacapavir contracted HIV, achieving 100% efficacy. In contrast, 1.5% of the women on Truvada and 1.8% on Descovy contracted HIV. Due to these promising results, an independent data safety monitoring board recommended unblinding the trial and offering participants a choice of PrEP.
Significance of the breakthrough
Bekker emphasized the potential impact of this new prevention tool, noting that despite existing methods, new HIV infections, particularly among young people, remain a challenge. The convenience of a biannual injection could significantly reduce barriers to adherence compared to daily pills.
This advancement comes at a crucial time, with 1.3 million new HIV infections reported globally in the past year. To meet UNAIDS targets and ultimately end AIDS by 2030, new and effective prevention methods like lenacapavir are essential.
Next steps and future prospects
The Purpose 1 trial will continue in an open-label phase, with participants choosing their preferred PrEP. Additionally, the Purpose 2 trial is ongoing, testing lenacapavir among diverse groups, including cisgender men and transgender individuals.
Gilead Sciences plans to submit the trial results to regulators in Uganda and South Africa within the next few months. The World Health Organization will also review the data, potentially integrating lenacapavir into global and national HIV prevention guidelines.
Ensuring affordability and accessibility, particularly in the public sector, is crucial. Gilead has indicated it will offer licenses for generic production to help lower costs, aiming for widespread availability of this life-saving drug.
