Durability of Long-Acting Cabotegravir + Rilpivirine in Virologically Suppressed Adults Living With HIV: A Multicenter Observational Cohort in Tuscany (LAHIV)

To evaluate the durability of long-acting cabotegravir (CAB) plus rilpivirine (RPV), available in Italy since June 2022, for maintaining HIV-1 virological suppression. This multicentric observational study included 191 virologically suppressed adults (HIV-RNA < 50 copies/mL) from 11 centers in Tuscany, followed from first CAB + RPV injection until discontinuation, death, or last visit. Discontinuation was defined as regimen switch or two consecutive missed doses, virological failure (VF) as two consecutive HIV-RNA > 50 copies/mL or a single > 1000 copies/mL. Kaplan-Meier survival analysis assessed discontinuation rates. Follow-up was 209.5 person-years with a median of 1 year (IQR 0.5-1.5). Median age was 51 years (IQR 43-58); 81.7% were male; median ART duration was 13.8 years (IQR 8.7-20.2). Eighteen participants (9.2%) discontinued due to adverse events (3.7%), VF (2.6%), personal choice (2.1%), medical decision (0.5%), or loss to follow-up (0.5%). Overall discontinuation was 8.5/100 person-years (95% CI: 5.4-13.6). VF incidence was 2.3/100 person-years (95% CI 0.9-5.7). All VFs, occurred within 28 weeks, except one at Week 72 with resistance mutations. Discontinuation rates were slightly higher than clinical trials but consistent with real-world data. The VF incidence was slightly higher than reported in prior reports, highlighting the need for real-life clinical monitoring.