Real-world evidence show that GSK and ViiV Healthcare’s long-acting pre-exposure prophylaxis Apretude can prevent nearly all HIV infections, while rival Gilead Sciences is moving quickly toward an approval for a twice-yearly option.
GSK and ViiV Healthcare’s pre-exposure prophylaxis drug Apretude is more than 99% effective at preventing HIV infections, according to real-world results being presented at this week’s IDWeek 2024 conference.
The results came from the real-world OPERA and Trio Health cohorts, which together enrolled almost 1,300 individuals, and “support the strong and sustained effectiveness of Apretude … outside the controlled environment of a clinical trial,” ViiV CMO Harmony Garges said in a statement. These data “add to the growing body of evidence generated over the last three years, showing [Apretude] for PrEP is a highly effective option for HIV prevention.”
In Trio Health, which involved both cis- and transgender male and female participants, none of the patients taking Apretude PrEP were diagnosed with HIV during follow-up. Adherence to the injection was high, with only 3% of participants missing a dose. Similar findings were obtained from OPERA, which showed that 762 of 764 patients on Apretude remained free of HIV during follow-up, resulting in a 99.7% effectiveness rate.
Of the two patients who were diagnosed with HIV, one had discontinued Apretude while the other had inconsistent testing. According to ViiV, the HIV diagnoses in these patients “could not be directly linked to the regimen.”
GSK and ViiV are also presenting data from the PILLAR implementation study at IDWeek 2024, touting quality of life improvements in men who have sex with men and transgender men on Apretude. Six-month findings from PILLAR showed that Apretude lowered PrEP stigma and anxiety among study participants, compared with oral PrEP. Participants also found the long-acting injectable to be feasible, acceptable and convenient.
Apretude is an intramuscularly administered HIV-1 integrase strand transfer inhibitor. It works by preventing the virus’ genetic material from being integrated into the host DNA, disrupting the HIV replication cycle. First approved in 2021, Apretude is the first long-acting PrEP to hit the U.S. market.
GSK and ViiV are working to extend the dosing interval of Apretude, which is currently approved to be given every two months. Meanwhile, its top HIV competitor Gilead is moving quickly toward an approval for a twice-yearly option.
In June 2024, Gilead released data from the Phase III PURPOSE 1 study, announcing that its investigational PrEP shot lenacapavir showed 100% efficacy in preventing HIV in cisgender women.
Gilead bolstered these findings last month with an interim readout from PURPOSE 2, which showed that the twice-yearly injection reduced HIV infections by 96% in a diverse study population—including cisgender men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth. Of the 2,180 participants, only two patients were diagnosed with HIV, suggesting that 99.9% of participants remained free of the infection at the time of the analysis.
Gilead is working toward regulatory filings by the end of the year, with a potential launch in 2025.
