GSK, ViiV Claim 99% PrEP Effectiveness as Gilead Advances

Poznan, Poland – October 29, 2020: The GlaxoSmithKline (GSK) headquarters office building in Poznan showcases the company's commitment to innovative pharmaceutical solutions. GSK, also known as GlaxoSmithKline, is a British pharmaceutical giant making significant strides in HIV prevention alongside its partner, ViiV Healthcare.

Recent real-world evidence highlights the impressive efficacy of GSK and ViiV Healthcare’s long-acting pre-exposure prophylaxis (PrEP) drug, Apretude, in preventing nearly all HIV infections. This has been presented at the IDWeek 2024 conference. According to findings from the OPERA and Trio Health cohorts, which included nearly 1,300 participants, Apretude has shown more than 99% effectiveness in preventing HIV.

In the Trio Health study, involving both cis- and transgender male and female participants, none of the individuals on Apretude PrEP were diagnosed with HIV during the follow-up period. Adherence to the injection was notably high, with only 3% of participants missing a dose. Similarly, the OPERA study demonstrated that out of 764 patients on Apretude, 762 remained HIV-free during follow-up, resulting in a 99.7% effectiveness rate.

Of the two patients diagnosed with HIV, one had stopped using Apretude, and the other had inconsistent testing. ViiV Healthcare clarified that these diagnoses could not be directly attributed to the Apretude regimen. Harmony Garges, ViiV's Chief Medical Officer, emphasized that these real-world data support the strong and sustained effectiveness of Apretude outside controlled clinical trials, adding to the growing body of evidence over the last three years that Apretude is a highly effective option for HIV prevention.

Beyond its preventive efficacy, GSK and ViiV Healthcare are showcasing additional findings from the PILLAR implementation study at IDWeek 2024. This study highlights quality of life improvements, particularly among men who have sex with men and transgender men using Apretude. Six-month results from PILLAR indicated that Apretude reduced PrEP-related stigma and anxiety compared to oral PrEP. Participants found the long-acting injectable to be feasible, acceptable, and convenient.

Apretude, an intramuscularly administered HIV-1 integrase strand transfer inhibitor, works by preventing the integration of the virus’ genetic material into the host DNA, thereby disrupting the HIV replication cycle. First approved in 2021, Apretude is the pioneering long-acting PrEP available in the U.S. market.

GSK and ViiV are also exploring the potential to extend the dosing interval of Apretude, currently approved for administration every two months. Concurrently, their main competitor, Gilead Sciences, is advancing rapidly towards the approval of a twice-yearly PrEP option.

In June 2024, Gilead presented promising data from the Phase III PURPOSE 1 study, demonstrating that its investigational PrEP shot, lenacapavir, achieved 100% efficacy in preventing HIV in cisgender women. This was reinforced by interim results from PURPOSE 2, showing that the twice-yearly injection reduced HIV infections by 96% in a diverse study population, which included cisgender men, transgender men, transgender women, and gender non-binary individuals who have sex with partners assigned male at birth. Among the 2,180 participants, only two were diagnosed with HIV, indicating that 99.9% remained free of the infection at the time of analysis.

Gilead aims for regulatory filings by the end of the year, with the potential for a product launch in 2025. As the landscape of HIV prevention continues to evolve, these advancements highlight the ongoing efforts and competition among pharmaceutical companies to provide effective, long-lasting solutions for those at risk of HIV.