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Real-world data demonstrated that Apretude (cabotegravir long-acting [CAB-LA]; ViiV Healthcare) for HIV pre-exposure prophylaxis (PrEP) produced efficacy of more than 99% in preventing HIV infection.1 These data from a pair of real-world evidence studies—the OPERA trial and Trio Health cohorts—presented at IDWeek 2024, showed high adherence rates and decreased stigma and anxiety among those administered Apretude.
“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,” Harmony P. Garges, MD, MPH, chief medical officer at ViiV Healthcare, said in a press release. “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. 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.”1
Apretude was approved by the FDA on December 21, 2021, for PrEP in adults and adolescents weighing at least 35 kg to lower the risk of acquiring HIV through sexual activity.2 Apretude, an antiretroviral medication, inhibits HIV from replicating by attaching to the active site of integrase and blocking the strand transfer step of retroviral DNA integration. This ultimately stops HIV DNA from integration into human DNA, thereby preventing the virus from replicating. Apretude is comprised of an extended-release injectable suspension administered through gluteal intramuscular injection. Oral cabotegravir can be initiated before administration of Apretude, or patients may initiate PrEP with Apretude without starting on oral cabotegravir.3
The Trio Health cohort evaluated real-world use with Apretude for PrEP in 474 individuals in the United States, representing a diverse group of cisgender and transgender individuals. Data were gathered from electronic health records between December 2021 and January 2024.
Investigators found zero HIV diagnoses among participants taking Apretude, with 83% remaining on Apretude at the time of analysis. Among 396 participants with continuation injections, 33% had delayed injection, showing a median of one delayed injection and median delay of 12 days [IQR: 3-29]. Apretude adherence rates showed promise, with only 3% of patients missing an injection.
The OPERA trial evaluated injection timing, adherence, and efficacy of Apretude among a large, diverse cohort comprised of 764 individuals using Apretude for PrEP, with 29% being Black and 29% Hispanic. Apretude showed efficacy in 99.7% of individuals, as 762 individuals were not diagnosed with HIV during the follow-up period and two cases of HIV among those taking Apretude for PrEP. Investigators noted that these cases could not be directly linked to Apretude because of discontinuation and inconsistent testing in each case, respectively. Further, 85% of those administered Apretude showed complete initiation of the regimen and 69% of complete initiators received all injections on time. Most injection delays were found to be short in duration, at a median delay of three days from the target date.
Further data from the PILLAR implementation study showed that men who have sex with men and transgender men taking Apretude for PrEP experienced significantly reduced stigma and anxiety compared to oral PrEP. Despite some minor injection site reactions, participants reported elevated confidence in HIV protection, with adherence supported by flexible clinic practices and virtual appointments.
ViiV stated that it will continue to evaluate the long-term benefits of Apretude for PrEP to further optimize use of the medication.
References
1. 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. ViiV Healthcare. October 16, 2024. Accessed October 16, 2024. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/october/real-world-studies-for-apretude/
2. FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention. FDA News Release. Published December 20, 2021. Accessed October 16, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention
3. Apretude –PRESCRIBING INFORMATION. APRETUDE (cabotegravir) Label (fda.gov). Accessed October 16, 2024.