Real-World Data Demonstrates Cabotegravir is Highly Effective PrEP
At ID Week 2024, ViiV Healthcare reports its long-acting PrEP, cabotegravir (Apretude), is more than 99% effective.
Image credit: ViiV Healthcare
ViiV Healthcare announced this week that its cabotegravir long-acting (LA) for PrEP in real life, outside the controlled environment of a clinical trial. The data include effectiveness, adherence, and quality-of-life improvement results for individuals taking Apretude across 3 US studies.
Findings from 2 real-world evidence studies (from OPERA and Trio Health cohorts) showed more than 99% effectiveness of CAB LA for PrEP in nearly 1300 individuals. In the PILLAR implementation study, reductions were shown in stigma and anxiety among the 200 individuals using the long-acting injectable PrEP option.
“The findings presented at IDWeek 2024 continue to support the strong and sustained effectiveness of Apretude 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 three years, showing CAB LA for PrEP is a highly effective option for HIV prevention,” ViiV Healthcare CMO Harmony Garges, MD, MPH, said in a statement. "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.”
OPERA and Trio Health Results
New data from the Trio Health cohort shows the real-world use of CAB LA for PrEP in preventing HIV acquisition and adherence, among 474 individuals in the US. The analysis identified a diverse population of cis- and transgender male and female individuals initiating CAB LA for PrEP from electronic health records between December 2021 through January 2024.
Findings from the cohort showed that there were zero HIV diagnoses identified during follow-up among participants taking CAB LA for PrEP. Eighty-three percent persisted on CAB LA for PrEP injections at the time of analysis, and injections were also administered on time for most of the initiators. Of the 396 participants with continuation injections, 33% experienced delays with a median of one delayed injection and median delay of 12 days [IQR: 3-29]. Adherence to CAB LA for PrEP was high, with only 3% of participants experiencing a missed injection.
Real-world findings from the OPERA study provide insights into injection timing, adherence, and effectiveness among individuals using CAB LA for PrEP in the US. The OPERA study reported findings from a large, diverse US cohort, which included 764 individuals using CAB LA for PrEP, 29% of whom are Black and 29% Hispanic.
CAB LA for PrEP was effective in 99.7% of individuals (762 of 764 were not diagnosed with HIV during the follow-up period). There were 2 cases of HIV (0.3%) observed among the CAB LA for PrEP initiators. These cases could not be directly linked to the regimen due to its discontinuation in 1 case and inconsistent testing in the other case.
Eighty-five percent of individuals taking CAB LA for PrEP had complete initiation of the regimen. Sixty-nine percent of these complete initiators received all of their continuation injections on time. While some injection delays were observed among those with complete initiation, most were short, with a median delay of 3 days from the target date.
