Zero HIV Cases with Apretude

Real-world data were also presented for Cabenuva, the only approved, complete long-acting injectable treatment regimen, showing its effectiveness in the three years since it has been available. These data were presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), in San Francisco, U.S.

Harmony P. Garges, M.D. MPH., Chief Medical Officer at ViiV Healthcare, said: “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. Our ongoing, real-world and implementation studies for Apretude show effectiveness of HIV prevention of more than 99% in nearly 4,000 people; and we have real-world experience in more than 15,000 people receiving Cabenuva for HIV treatment showing continued high effectiveness up to two years. Our data at CROI 2025 reinforce that, across a broad range of settings and populations, our long-acting injectables provide a highly effective option for both HIV treatment and prevention, that remove the need for daily pills.”

Ricky Hsu, M.D., Department of Medicine, NYU Grossman School of Medicine and Medical Director, AHF Healthcare Center, said: “While randomised clinical trials are the gold standard for testing the safety and efficacy of medicines, real-world evidence can provide a fuller understanding of the safety and effectiveness of a therapy over time. Since ViiV Healthcare’s introduction of long-acting injectables, generating these valuable insights is more important than ever to help providers decide who could benefit from particular medicines and better understand how they address the everyday needs of people impacted by HIV."

Highlights from ViiV Healthcare and partner real-world and implementation studies for long-acting injectables Apretude (prevention) and Cabenuva (treatment):

1. PILLAR 12-month clinical results: zero HIV acquisition and high persistence with CAB LA for PrEP: New 12-month findings from the PILLAR study explore effectiveness, diagnostic testing, persistence (time that an individual continued to receive injections), safety and tolerability of CAB LA in 201 participants. PILLAR is a phase IV implementation trial assessing the integration of CAB LA for PrEP across 17 clinics in the U.S. among a diverse population of men who have sex with men and transgender men, 26% of whom were Black and 38% Hispanic/Latino.

No cases of HIV acquisition were observed through 12 months. Persistence on CAB LA was high, at 85% (n=171/201) at six months and 72% (n=142/196) at 12 months; excluding five participants who completed the study post-data cutoff. Five participants missed an injection and received either oral CAB or alternative PrEP. Adverse events (AEs) related to CAB LA were uncommon, with injection site pain the most frequently reported (3%, n=6). Five percent of participants (n=11) had AEs leading to discontinuation, most commonly due to injection site pain.These implementation study data - obtained from a diverse population - support CAB LA as an effective PrEP option associated with high persistence.

2. ImPrEP CAB Brazil implementation study data shows significantly improved PrEP coverage and protection with CAB LA: The ImPrEP CAB Brazil study (The Choice Cohort) assessed PrEP coverage and HIV incidence among 1,447 participants who were given the choice of CAB LA or oral PrEP (TDF/FTC) for HIV prevention. The Choice Cohort included PrEP-naïve, cisgender men who have sex with men, non-binary and trans people aged 18 to 30. As a comparison group, the study assessed 2,263 people of a similar demographic, initiating oral PrEP through the Brazilian public health system during the same period.

The results show that offering CAB LA injections significantly improved PrEP coverage and HIV prevention for young key populations, reinforcing the role of CAB LA in addressing adherence challenges some people face with oral PrEP. Eighty-three percent of the 1,447 participants who were free to choose either CAB LA or oral PrEP chose CAB LA (1,200 participants) and there were zero HIV acquisitions reported over 798.4 person-years in The Choice Cohort. There were eight HIV acquisitions over 408.52 person-years reported in the comparison group (incidence rate 1.96 [95% CI 0.98-3.92] per 100 person-years). The proportion of individuals covered by PrEP during follow-up was highest in the CAB LA group (96.2%, 221,273/ 229,951 days), followed by the oral PrEP group within The Choice Cohort (64.1%, 32,272/ 50,310 days) and lowest in the comparison group (47.4%, 191,765/ 404,781 days).

The study is sponsored by the Evandro Chagas National Institute of Infectious Diseases at the Oswaldo Cruz Foundation, Brazil, and funded by Unitaid.

3. Real-world data from OPERA show high effectiveness of CAB + RPV LA in broad populations: The first of two OPERA analyses looked at long-term effectiveness in diverse virologically suppressed individuals on CAB+RPV LA - 42% of whom are Black and 30% Hispanic - through two years.

In this large (n=2,485) U.S. cohort of individuals who switched to CAB + RPV LA, with a median follow-up time of 11 months (IQR: 6-18), 95% maintained virological suppression (<50c/ml at last Viral Load (VL)) and 1% (n=21) experienced confirmed virologic failure (CVF) after a median of seven months. Outcomes were consistent over time through 24 months and across BMI categories (<30 kg/m2, ≥30 kg/m2).

In a second analysis among a diverse group of 381 virologically suppressed women with HIV, with a median follow-up time of 12 months (IQR:7-19), 94% maintained suppression at their last viral load and CVF was ≤1.3% (n≤5).

4. High rates of viral suppression observed in Trio Health cohort: The Trio Health cohort followed 928 virologically suppressed individuals initiating CAB + RPV LA in real-world settings in the U.S. The median (IQR) follow-up time after the first injection was 12 months (5-19) and 89% of injections (6176/6934) were administered without delay (<7 days after the target dosing date). Ninety-five percent of individuals on CAB+RPV LA maintained viral suppression (last VL <50 c/mL) and 1.6% (n=15) experienced CVF.

These studies add to the real-world evidence supporting CAB+RPV LA’s high effectiveness in a broad range of populations.