Real-World Evidence Presented at IDWeek Demonstrates Efficacy of ...

Both real-world evidence and implementation data demonstrating the effectiveness, adherence, and improvements in quality of life reported by those receiving cabotegravir long-acting (CAB LA, Apretude; ViiV Healthcare) for HIV pre-exposure prophylaxis (PrEP) were announced. The data were presented at Infectious Disease Week (IDWeek) 2024, which was held in Los Angeles, California, from October 16 to 19, 2024. The real-world evidence comes from OPERA and Trio Health cohorts, and the implementation data from the PILLAR study (NCT05374525).1

CAB LA can be used to prevent sexually transmitted HIV infection PrEP in adults and adolescents who weigh at least 35 kg and are at a high risk of being infected. Although it is used to prevent HIV transmission, experts urge that it should be used in combination with safe sex practices, such as using condoms. In findings from 2 real-world studies, the OPERA and Trio Health cohorts, CAB LA demonstrated over 99% effectiveness when used as PrEP in nearly 1300 individuals. Additionally, it demonstrated reductions in both stigma and anxiety among the 200 participants using the long-acting injectable option in the PILLAR implementation study.1

New data from the Trio Health cohort demonstrated that there were no HIV diagnoses when CAB LA was used as PrEP for the prevention of HIV acquisition and adherence among a diverse population of 474 cisgender and transgender male and female individuals. Additionally, 83% of participants persisted on CAB LA for PrEP at the time of the analysis, and injections were administered on time for most initiators. Of the 396 who continued injections, 33% experienced delays with a median of 1 delayed injection and median delay of 12 days (IQR 3-29), but adherence was very high.1

This builds off previous analysis findings, which demonstrated that in 85 participants who received at least 1 CAB LA injection, 74% of individuals had either HIV Ag/Ab or HIV RNA results at all injections, while 44% had HIV Ag/Ab results, 40% had HIV RNA results, and 20% of individuals had both HIV RNA and HIV Ag/Ab results, and no HIV diagnoses were identified. There were also no missed injections by participants, although some (n = 64) received 2 or more.2

Additionally, the real-world evidence from the OPERA study demonstrated that CAB LA for PrEP was effective in about 99.7% of individuals, with 762 of 764 participants not being diagnosed with HIV during the follow-up period. Only 2 HIV cases (0.3%) were observed; however, the investigators noted that these could not be directly linked to the regimen because 1 case was a discontinuation, and the other was tested inconsistently. Approximately 85% of those taking CAB LA had completed initiation of the regimen (completion for the first 2 initiation injections were completed 60 days or less apart from each other), and 69% of those received all their continuation injections on time. Most injection delays observed were short, with a median delay of 3 days from the target date.1

These findings are more positive compared to an early analysis, which shows that there were diagnoses of sexually transmitted infections (STIs) and multiple HIV tests in the 12 months following early adoption of CAB LA for PrEP. Only 11% of the 498 individuals had missed an injection, and the authors noted that the number of positive tests may have been an overestimation of true therapeutic gaps because oral bridging was utilized.3

Further, 6-month findings from the PILLAR trial (NCT05374525), a randomized, open-label, 2-arm phase 4 implementation study which included over 200 men who have sex with men (MSM) and transgender men who initiated CAB LA for PrEP following prior experience with daily oral PrEP, showed that those taking CAB LA reported lower rates of anxiety and stigma compared with their prior oral PrEP experiencing. Additionally, they reported that the long-acting injection was more feasible, acceptable, and convenient. About 15% of participants reported feeling worried about their privacy while taking oral PrEP, 24% felt that they had to hide their oral PrEP from others, and 29% were worried about stigma. At 6 months, less than 1% reported concerns about privacy, and only 1% expressed concerns about stigma.1

“The findings presented at IDWeek 2024 continue to support the strong and sustained effectiveness of [CAB LA] for people in real life, outside the controlled environment of a clinical trial. The results of the studies from OPERA and Trio cohorts add to the growing body of evidence generated over the last 3 years, showing CAB LA for PrEP is a highly effective option for HIV prevention,” Harmony P Garges, MD, MPH, chief medical officer at ViiV Healthcare, said in a news release.1

According to experts, some common adverse events (AEs) reported by those who received CAB LA were injection site reactions, headache, diarrhea, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.5 Further, in the PILLAR trial, approximately 45% of participants reported injection site reactions, and among this group, about 86% were able to return to their daily activities on the same day with only few (8%) reporting feeling bothered by injection pain. Additionally, this 8% had reported that the pain decreased during following injections.1

“We believe long-acting options have the potential to be transformative in increasing uptake among a broad range of people that could benefit from PrEP and are critical to ending the HIV epidemic,” said Garges in the news release.1

REFERENCESGSK. ViiV Healthcare shows more than 99% effectiveness in real-world studies for Apretude (cabotegravir long-acting), the only approved long-acting HIV PrEP, in data presented at IDWeek 2024. News release. October 16, 2024. Accessed October 22, 2024. https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-shows-more-than-99-effectiveness-in-real-world-studies-for-apretude/Mayer KH, Frick AJ, Brown C, et al. Abstract #1110—Real-World Use of Cabotegravir Long-Acting for Preexposure Prophylaxis: Trio Health Cohort. Presented at: Conference on Retroviruses and Opportunistic Infections. Denver, Colorado. March 3-6, 2024. https://www.croiconference.org/abstract/real-world-use-of-cabotegravir-long-acting-for-preexposure-prophylaxis-trio-health-cohort/Mills A, Brunet L, Mounzer K, et al. Abstract #1109—Preexposure Prophylaxis With Cabotegravir Long-Acting Injectable in the OPERA Cohort. Presented at: Conference on Retroviruses and Opportunistic Infections. Denver, Colorado. March 3-6, 2024. https://www.croiconference.org/abstract/preexposure-prophylaxis-with-cabotegravir-long-acting-injectable-in-the-opera-cohort/A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States (PILLAR). ClinicalTrials.gov identifier: NCT05374525. Updated February 14, 2024. Accessed October 22, 2024. https://clinicaltrials.gov/study/NCT05374525BioSpace. ViiV Healthcare Shows More Than 99% Effectiveness in Real-World Studies for Apretude (Cabotegravir Long-Acting), the Only Approved Long-Acting HIV PrEP, in Data Presented at IDWeek 2024. News release. October 16, 2024. Accessed October 22, 2024. https://www.biospace.com/press-releases/viiv-healthcare-shows-more-than-99-effectiveness-in-real-world-studies-for-apretude-cabotegravir-long-acting-the-only-approved-long-acting-hiv-prep-in-data-presented-at-idweek-2024