User-reported outcomes of long-acting injectable PrEP with Cabotegravir: Real-world experience from Milan

Introduction: Oral HIV pre-exposure prophylaxis (PrEP) is highly effective, but adherence and persistence are often limited by side effects, pill fatigue and stigma. Long-acting injectable cabotegravir (CAB-LA) offers a discreet, convenient alternative with the potential to improve user experience and HIV protection. Data on real-world use in Europe remain limited. The aim is to describe user-reported outcomes from individuals initiating CAB-LA PrEP. Methods: This is a prospective cohort study enrolling participants receiving CAB-LA between November 2024 and July 2025 at a large teaching hospital in Milan, Italy (San Raffaele Institute). At each injection visit, user-reported outcomes on satisfaction, adherence, perceived protection, quality of life and adverse events, including injection site reactions (ISRs) using a self-reported survey developed for the study were collected. Results: Eighty-two participants (97.6% cis-MSM, median age 41.4 years) were included (median injections 4, range 2–5). Most (95.1%) had prior oral PrEP experience; 26.9% reported previous oral PrEP side effects, and 15.4% poor adherence. CAB-LA satisfaction remained high: at the fourth injection, 90.9% reported a positive overall opinion, and 84.4% felt more protected than on oral PrEP. Convenience and elimination of daily pill-taking were valued by >94%. Self-reported adherence improved in 75.3%. Side effects were mostly mild or unchanged compared with oral PrEP; systemic adverse events were uncommon and ISRs were generally minimal. Conclusions: In this real-world cohort, CAB-LA PrEP was highly acceptable, well tolerated and associated with improved perceived adherence, convenience and HIV protection. These findings support CAB-LA as a promising, user-centred HIV prevention strategy, potentially overcoming key limitations of daily oral PrEP.