New HIV Prevention Drug Shows 100% Efficacy in Clinical Trial

🌈 Abstract

The article discusses the results of a large clinical trial in South Africa and Uganda that tested a new pre-exposure prophylaxis (PrEP) drug, lenacapavir, which is administered as a twice-yearly injection. The trial showed that lenacapavir provided 100% protection against HIV infection in young women, outperforming the existing daily PrEP pills Truvada and Descovy.

🙋 Q&A

[01] The Purpose 1 Trial

1. What were the key objectives of the Purpose 1 trial?

• The trial tested whether a six-monthly injection of lenacapavir (Len LA) would provide better protection against HIV infection as PrEP for women aged 16-25 years compared to the daily PrEP pills Truvada (F/TDF) and Descovy (F/TAF).
• It also tested whether Descovy (F/TAF) was as effective as Truvada (F/TDF).

2. What were the results of the trial?

• During the randomized phase, none of the 2,134 women who received the lenacapavir injection contracted HIV, showing 100% efficacy.
• In comparison, 16 out of 1,068 (1.5%) women who took Truvada (F/TDF) and 39 out of 2,136 (1.8%) who took Descovy (F/TAF) contracted HIV.

3. What led to the trial's "blinded" phase being stopped?

• The independent data safety monitoring board reviewed the results and recommended that the blinded phase be stopped and all participants be offered a choice of PrEP, due to the clear benefit of lenacapavir over the other two drugs.

[02] Significance and Next Steps

1. Why is this breakthrough significant?

• It provides a highly effective prevention tool to protect people, especially young women, from HIV infection.
• The twice-yearly injection could be more feasible for young people compared to the daily pill regimen.

2. What are the next steps for this new PrEP drug?

• Gilead Sciences plans to submit the trial results to regulators in Uganda, South Africa, and the World Health Organization in the coming months.
• The drug will likely be incorporated into WHO and country guidelines if approved.
• Further studies will be conducted to understand how to best incorporate the drug into real-world settings.
• Ensuring affordable pricing and access, especially in the public sector, will be a critical factor.