Apretude (cabotegravir) 99% effective in real-world HIV PrEP studies, ViiV Healthcare reports at IDWeek 2024

GSK plc recently announced significant findings from ViiV Healthcare concerning the effectiveness and adherence of Apretude (cabotegravir long-acting or CAB LA) for HIV pre-exposure prophylaxis (PrEP). These findings will be presented at the IDWeek 2024 conference held in Los Angeles, California from October 16-19. ViiV Healthcare, a specialist in HIV treatment and prevention, is majority-owned by GSK, with Pfizer and Shionogi as shareholders.

Real-world evidence from the OPERA and Trio Health cohorts demonstrated that CAB LA for PrEP is more than 99% effective in nearly 1,300 individuals. Additionally, the PILLAR implementation study highlighted reductions in stigma and anxiety among 200 individuals using this long-acting injectable PrEP option.

Harmony P. Garges, Chief Medical Officer at ViiV Healthcare, emphasized the importance of these findings, noting that they support the long-term effectiveness of Apretude in real-life scenarios, beyond controlled clinical trials. Garges pointed out that these long-acting options could be transformative in enhancing the uptake of PrEP among a diverse range of people, thereby playing a critical role in ending the HIV epidemic.

A deeper look into the Trio Health cohort revealed that, among 474 individuals in the U.S. using CAB LA for PrEP, there were zero cases of HIV acquisition. The study highlighted high adherence rates, with 83% of participants continuing with the injections as scheduled. While 33% of the 396 participants who continued with the injections experienced delays, the median delay was just 12 days, and only 3% missed an injection altogether, demonstrating overall strong adherence.

The OPERA study provided further insights from a large and diverse U.S. cohort, including 764 individuals using CAB LA for PrEP. Of these, 29% were Black and 29% Hispanic. The study showed that CAB LA was 99.7% effective, with only two cases of HIV observed. These cases were not directly linked to the regimen due to discontinuation and inconsistent testing. The study also noted that 85% of participants completed their initial injections within the specified timeframe, and 69% received all continuation injections on time. Delays were generally short, with a median delay of three days.

The PILLAR implementation study explored the experiences of over 200 men who have sex with men (MSM) and transgender men (TGM) who switched from daily oral PrEP to CAB LA for PrEP. Conducted across 17 U.S. clinics, the study included 23% Black and 39% Hispanic/Latino participants. Findings indicated that CAB LA for PrEP significantly reduced concerns related to stigma and anxiety compared to oral PrEP. Initially, 15% of participants worried about privacy with oral PrEP, 24% felt the need to hide their medication, and 29% were concerned about stigma. After six months of using CAB LA, less than 1% reported privacy concerns and only 1% worried about stigma.

Despite 45% of participants reporting injection site reactions, 86% resumed daily activities the same day, and only 8% were bothered by injection pain, which decreased over time. The acceptability of CAB LA for PrEP was high, with mean acceptability scores increasing from 4.4 to 4.6 over six months. Factors like flexible clinic scheduling, transportation assistance, and virtual appointments contributed to adherence.

These studies underscore ViiV Healthcare's commitment to providing robust real-world evidence for CAB LA for PrEP, enhancing understanding of its implementation and impact on diverse communities. Ongoing research will continue to explore the long-term benefits and optimization of CAB LA for PrEP.

Apretude, containing the active substance cabotegravir, is used for preventing sexually transmitted HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg. It should be used alongside safer sex practices, such as condom use.