WHO: Long-acting Injectable Lenacapavir Proves Effective in HIV Prevention for Women
WHO is pleased with the effectiveness of long-acting lenacapavir as PrEP in preventing HIV acquisition among women. The PURPOSE 1 trial results confirmed the safety and efficacy of this injectable drug for HIV prevention in HIV-negative cisgender women. Lenacapavir is an HIV-1 capsid inhibitor administered twice a year via subcutaneous injection. The study revealed no new infections among users of lenacapavir.
Women in high HIV incidence areas, such as East and southern Africa, require additional HIV prevention options, including PrEP. Lenacapavir offers a promising solution to increase prevention choices for women, addressing challenges associated with oral tablets. Despite the positive results, safety concerns in pregnancy and breastfeeding, HIV testing protocols, potential drug resistance, and real-world implementation need to be addressed. WHO eagerly anticipates data from PURPOSE 2 to expand lenacapavir use to other gender groups. Various PrEP options have been recommended by WHO, with implementation tools available for safe and efficient use.
About the PURPOSE 1 trial
PURPOSE 1 enrolled 5345 adolescent girls and young women aged 16–26 years at 25 sites in South Africa and three in Uganda. The median age of all trial participants was 21 years.
The study randomized participants to one of three arms:
- Arm A – LEN (as a subcutaneous injection every 6 months) and placebo daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or placebo daily oral tenofovir alafenamide fumarate/emtricitabine (TAF/FTC).
- Arm B – Daily oral TAF/FTC and placebo subcutaneous LEN every 6 months.
- Arm C – Daily oral TDF/FTC and placebo subcutaneous LEN every 6 months.
Results
Fifty-five women in the trial acquired HIV. Sixteen (16/1068) were randomized to the daily, oral TDF/FTC arm (1.69/100 person-years; 95% CI, 0.96 to 2.74) and 39 (39/2136) were randomized to the daily, oral TAF/FTC arm (2.02/100 person-years; 95% CI, 1.44 to 2.76). There were zero (0/2138) infections in the LEN arm.
Overall adherence to TDF/FTC and TDF/TAF was poor. Among the 55 women in the TDF and TAF arms who acquired HIV, most had low to no tenofovir detected in their blood.
LEN, oral TDF/FTC and oral TAF/FTC were all well tolerated. Injection site reactions (ISRs) related to the study drug or injection procedures were the most common adverse events observed (LEN: 68.8%; placebo: 34.9%). There were no serious ISRs among participants receiving lenacapavir or placebo injections. Four women in the lenacapavir group (0.2%) discontinued study drug due to ISRs. None of the women receiving placebo injections discontinued due to ISRs. More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at www.purposestudies.com
Read full article at: https://www.who.int/news/item/26-07-2024-long-acting-injectable-lenacapavir-proves-effective-in-hiv-prevention-for-women