ViiV's Apretude Over 99% Effective in Real-World HIV PrEP Studies, IDWeek 2024

LONDON, UK I October 16, 2024 I ViiV Healthcare, a prominent global HIV specialist company primarily owned by GSK and shared by Pfizer and Shionogi, has announced new real-world evidence and implementation data showcasing the effectiveness, adherence, and quality-of-life benefits of Apretude (cabotegravir long-acting or CAB LA) for HIV pre-exposure prophylaxis (PrEP). These findings will be presented at IDWeek 2024, taking place in Los Angeles, California, from October 16 to 19.

Data from two real-world studies involving the OPERA and Trio Health cohorts revealed that CAB LA for PrEP demonstrated more than 99% effectiveness in nearly 1,300 individuals. Additionally, the PILLAR implementation study indicated reduced stigma and anxiety among the 200 individuals using this long-acting injectable PrEP option.

Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, emphasized that the results presented at IDWeek 2024 reinforce CAB LA's effectiveness outside clinical trials. The studies from the OPERA and Trio cohorts contribute to the growing body of evidence over the past three years, underscoring CAB LA as a highly effective HIV prevention option. Garges highlighted the transformative potential of long-acting options in increasing uptake among diverse populations that could benefit from PrEP, which is crucial in ending the HIV epidemic.

The Trio Health cohort study, comprising 474 individuals in the U.S., demonstrated zero HIV diagnoses during follow-up among those taking CAB LA for PrEP. The cohort included a diverse population of cisgender and transgender individuals who began using CAB LA for PrEP from December 2021 to January 2024. The study found that 83% of participants continued with CAB LA for PrEP injections at the time of analysis, with most receiving their injections on schedule. Delayed injections were observed in 33% of participants, with a median delay of 12 days. Adherence to CAB LA for PrEP was high, with only 3% missing an injection.

The OPERA study provided further insights into injection timing, adherence, and effectiveness among 764 individuals using CAB LA for PrEP in the U.S., with a diverse cohort including 29% Black and 29% Hispanic participants. The study showed that CAB LA for PrEP was effective in 99.7% of individuals, with only two cases of HIV observed, which could not be directly linked to the regimen due to discontinuation and inconsistent testing in each case. Eighty-five percent of individuals completed their initial two injections within the recommended 60-day period, and 69% received all subsequent injections on time. Delays were mostly short, with a median delay of three days.

The PILLAR implementation study explored the experiences of more than 200 men who have sex with men (MSM) and transgender men (TGM) who transitioned to CAB LA for PrEP from daily oral PrEP. Conducted across 17 U.S. clinics, the study included a diverse population with 23% Black and 39% Hispanic/Latino participants. Findings showed that those taking CAB LA for PrEP reported lower rates of stigma and anxiety compared to their prior oral PrEP experience. Concerns about privacy and stigma significantly decreased, with less than 1% of participants reporting such worries after six months. Participants also noted reduced stress and fear of missing a dose, along with confidence in HIV protection.

While 45% of participants experienced injection site reactions, the majority returned to daily activities the same day, with only 8% reporting being bothered by the pain, which lessened over time. CAB LA for PrEP demonstrated high acceptability, with mean scores increasing from 4.4 at baseline to 4.6 at six months. Participants found the injectable convenient, supported by flexible clinic scheduling, transportation assistance, and virtual appointments.

These real-world studies underline ViiV Healthcare's dedication to providing robust evidence for CAB LA for PrEP, studying its implementation, and comprehending its impact on diverse communities. Further research will continue to explore the long-term benefits of CAB LA for PrEP and enhance its usage.