Document resource
Background Long-acting cabotegravir plus rilpivirine (CAB+RPV) is the first intramuscular antiretroviral regimen approved for maintenance of HIV-1 virological suppression. Real-world data on durability and reasons for discontinuation are still limited.Methods This multicenter observational study included adults with HIV-RNA <50 copies/mL from 11 centres in Tuscany, Italy, including academic and non-academic institutions, reflecting a regional real-life setting. Participants were followed from the first CAB+RPV injection until treatment discontinuation, death, or last visit. Discontinuation (TD) was defined as regimen switch or two consecutive missed injections and was prospectively recorded, then classified a posteriori as virological failure (VF), toxicity/adverse reactions, patient-related reasons, or medical decisions. VF was defined as two consecutive HIV-RNA >50 copies/mL or a single HIV-RNA >1000 copies/mL. Kaplan–Meier analyses estimated treatment durability.Results We included 244 participants, contributing 330.3 person-years of follow-up (median 1.5 years, IQR 0.6–2.1). Median age was 51.3 years (IQR 44–57), 79.9% were male ( table 1). Twenty-seven participants (11.7%) discontinued CAB+RPV, corresponding to a TD rate of 8.1 per 100 py (95% CI 5.6–11.9). Median time to TD was 42 weeks (95% CI: 14–72). The probability of remaining on treatment was 91.5% (95% CI 86.6–94.6) at 1 year and 86.1% (95% CI 79.7–90.6) at 2 years (figure 1). TD was mainly due to adverse events (n=9; 3.6%), VF (n=7; 2.8%), or patient preference (n=6; 2.4%) (table 2). We observed, 7 VF (VF rate 2.1 per 100 person-years, 95% CI 1.0–4.4), including 2 HIV-RNA values between 50 and 200 copies/mL, 1 isolated cerebrospinal fluid viral escape, and 4 VF with HIV-RNA >1000 copies/mL. Among these 4 cases, NNRTI resistance mutations were present at baseline in one case and NNRTI and INSTI resistance emerged in another (1 out of 3), with viral resuppression after switching to TAF/FTC/DRV/c. All VFs occurred despite adherence to scheduled injections. Shorter duration of virological suppression prior to switch was associated with TD. Calendar year of LA ART initiation was significantly associated with TD. Compared with individuals initiating LA therapy in 2022, the risk was lower for those starting in 2023 (HR 0.30, 95% CI 0.12–0.78) and 2024 (HR 0.17, 95% CI 0.05–0.56). This temporal trend suggests a possible learning-curve or implementation effect during the early rollout of LA ART, with improved patient selection and management over time (figure 2).Conclusions In this region-wide real-world cohort including academic and non-academic centres, CAB+RPV showed good durability in routine clinical practice. TD rates were slightly higher than those reported in clinical trials but broadly consistent with other observational studies and may partly reflect the complexities of real-life implementation during the early adoption phase.Abstract P27 Figure 1Probability of remaining free from treatment discontinuation for all causes in adults with HIV-1 ART experienced with HIV-RNA level <50 copies/mL switching to RPV+CAB in Tuscany, ItalyAbstract P27 Table 1Clinical/demographic characteristics of adults with HIV-1, ART experienced with HIV-RNA level <50 coples/mL at switch to RPV+CAB in Tuscany, ItalyAbstract P27 Figure 2Probability of remaining free from treatment discontinuation for all causes in adults with HIV-1 ART experienced with HIV-RNA level <50 copies/mL switching to RPV+CAB in Tuscany, ItalyAbstract P27 Table 2Reasons tor d scontiruutior of RPY+CAS In a popnlation of aduits with HEY-1. ART esperienced wit HIV-PNA level <0 coples/mL In Tuscary, Italg