Real-World Data Demonstrates Efficacy of Apretude and Cabenuva in HIV Prevention, Treatment

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GSK's ViiV Healthcare released data at the Conference on Retroviruses and Opportunistic Infections showing the long-term efficacy of Apretude (cabotegravir long-acting) and Cabenuva (cabotegravir + rilpivirine long-acting) in preventing and treating HIV infection.¹

“As the leaders in long-acting injectables for HIV, we’re committed to collecting data to understand the effectiveness of these first-in-class medicines in real-world settings,” said Harmony P. Garges, MD, MPH, chief medical officer, ViiV Healthcare, in a press release. “Our ongoing real-world and implementation studies for Apretude show over 99% effectiveness in HIV prevention among nearly 4,000 people. Additionally, more than 15,000 individuals receiving Cabenuva for HIV treatment have demonstrated continued high effectiveness for up to two years. Our data at CROI 2025 reinforce that, across diverse settings and populations, our long-acting injectables provide a highly effective option for both HIV treatment and prevention—eliminating the need for daily pills.”

The Phase IV PILLAR trial was an implementation study that evaluated the integration of Apretude for pre-exposure prophylaxis (PrEP) in the United States. The study enrolled 201 participants, including men who have sex with men (MSM) and transgender men. At six months, 85% of participants remained on Apretude, though the persistence rate declined to 72% after one year. Three percent of participants reported injection site pain and five individuals discontinued treatment due to adverse events.

In the ImPrEP CAB Brazil study, researchers assessed PrEP coverage and HIV incidence in a cohort of 1,447 participants, which included cisgender MSM, non-binary individuals, and transgender people aged 18 to 30 years. Participants had the option to receive either Apretude or oral PrEP for HIV prevention.

Investigators also analyzed separate comparison group of 2,263 individuals who accessed oral PrEP through Brazil’s public health system, which found that 83% opted for Apretude over oral PrEP. Over a follow-up period representing 798.4 person-years, no HIV acquisitions were reported in those receiving Apretude, whereas the oral PrEP group had an HIV incidence rate of 1.96 per 100 person-years. In total, eight new HIV infections were reported in the comparison group over 408.52 person-years.

The OPERA cohort consisted of two analyses evaluating the long-term efficacy of Cabenuva in virologically suppressed individuals receiving HIV treatment. The first analysis included 2,485 individuals who transitioned to Cabenuva, with a median follow-up period of 11 months. At the last assessment, 95% of patients maintained virologic suppression, with only 1% experiencing confirmed virologic failure (CVF) after seven months. The second analysis included 381 virologically suppressed women living with HIV. At a median of one year, 94% of participants maintained virologic suppression, and the CVF rate was ≤1.3%.

The Trio Health cohort provided additional real-world data on Cabenuva’s use in clinical practice, analyzing outcomes from 928 virologically suppressed individuals. At a median follow-up of one year, 89% of injections were administered on schedule, 95% of participants maintained virologic suppression, and the CVF rate was 1.6%.¹

“While randomized clinical trials remain the gold standard for evaluating the safety and efficacy of medicines, real-world evidence provides a more comprehensive understanding of how therapies perform over time,” said Ricky Hsu, MD, Department of Medicine, NYU Grossman School of Medicine, and medical director, AHF Healthcare Center, in a press release. “Since ViiV Healthcare’s introduction of long-acting injectables, generating these valuable insights has become more important than ever. These data help providers determine who could benefit most from these therapies and better understand how they address the real-world needs of people impacted by HIV.”

Reference

1. ViiV Healthcare announces new implementation study data showing zero cases of HIV with Apretude, the only long-acting injectable approved for HIV PrEP. GSK. March 12, 2025. Accessed March 13, 2025.