GSK and ViiV Healthcare Report 99.7% Effectiveness for Long-Acting HIV PrEP Apretude in Real-World Data

Apretude is the world's first long-acting PrEP drug to enter the U.S. market, having been approved for the first time in 2021, with administration once every two months. At IDWeek 2024, ViiV Healthcare released new real-world data further highlighting Apretude’s strong efficacy.

Two real-world evidence studies from the OPERA and Trio Health cohorts showed that cabotegravir (the active ingredient in Apretude) was more than 99% effective for PrEP in nearly 1,300 people. In the Trio Health cohort, no HIV infections were found among 474 individuals using Apretude during the follow-up period, with high adherence; only 3% of participants missed one injection.

The OPERA study enrolled a large-scale, ethnically diverse population of subjects. The results showed that out of 764 subjects using Apretude, 762 were not diagnosed with HIV infection during the follow-up period, demonstrating an efficacy rate of 99.7%.

In addition, the results of the PILLAR trial showed that men who have sex with men and transgender men receiving Apretude therapy reported lower levels of stigma and anxiety. The long-acting injectable demonstrated feasibility, high acceptability, and high portability. The average acceptability score for Apretude among users increased from 4.4 at baseline to 4.6 at six months.

Apretude is an injectable HIV-1 integrase strand transfer inhibitor that disrupts the HIV replication cycle by preventing the integration of viral genetic material into host DNA. GSK and ViiV Healthcare are working to extend the dosing interval of Apretude, providing patients with an improved treatment experience.

Gilead Sciences is also not to be outdone in the long-acting HIV field. In June 2024, Gilead released data from the Phase 3 PURPOSE 1 study, announcing that its investigational PrEP injectable, lenacapavir, demonstrated 100% efficacy in preventing HIV among cisgender women. In the PURPOSE 1 trial, there were zero HIV infection cases among the 2,134 women in the lenacapavir group, compared to 16 cases in the Truvada group and 39 cases in the Descovy group.

Last month, Gilead Sciences further supported its research with the interim results of PURPOSE 2. The study showed that biannual injections of lenacapavir reduced HIV infection rates by 96% across different study populations. Among 2,180 participants, only two were diagnosed with HIV, indicating that 99.9% remained uninfected. Gilead plans to initiate global regulatory submissions for lenacapavir by the end of this year and aims to launch the drug in 2025.

GSK, ViiV Healthcare, and Gilead Sciences are all working to end the AIDS epidemic. In the future, with more in-depth research and the advancement of regulatory approvals, long-acting HIV drugs are expected to make greater contributions to the global fight against AIDS.