Journal Article

OC34 Durability of long acting cabotegravir and rilpivirine in a multicenter real-life cohort of people with HIV

Piacentini, D, Puzzolante, C, Lattuada, E, Mazzitelli, M, Cordioli, M, Raumer, F, Malena, M, Yaacoub, D, Battagin, G, Giglia, M, Mussini, C, Lanzafame, M, Rigamonti, C, Pieri, A, Fasani, G, Cozzolino, C, Nicolè, S, Cattelan, A, Calza, L, Zanchi, C, Rossi, M, Erne, E, Fontana, B

2025

Overview

BackgroundWe herein present a prospective multicenter experience on injectable cabotegravir and rilpivirine from 11 different HIV clinics in Northern Italy (Padova, Bologna, Belluno, Modena, Verona, Trento, Bolzano, Santorso, Rovigo, Treviso, Vicenza), focusing on the regimen durability, safety and tolerability in a real-life setting.Materials and MethodsFrom August 2022, we included all individuals who received at least one dose of injectable cabotegravir and rilpivirine across the 11 participating centers. We recorded demographic data and laboratory results, and assessed factors associated with treatment discontinuation (TD) for any cause and virological failure (VF), defined as two confirmed consecutive values of HIV RNA > 50 copies/ml or one single measurement of HIV RNA > 200 copies/ml. Kaplan-Meier curves were used to assess TD probability and logistic regression to identify significant predictors of TD and VF.Results483 PWH were included, mostly males (81.6%) and Caucasian (91.1%), with a median age of 49 (40–58) years, living with HIV for a median time of 12 (IQR:7–21) years, and a median CD4+ T cell count of 708 cell/mm3 (529–929). 45.5% and 7.5% had multimorbidity and polypharmacy, respectively. For 224 (43.6%) people HIV subtype was not available, 215 (44.5%) and 6 (1.2%) had a B and A subtype, respectively. 45.8% and 12.8% of participants had no genotype resistance test for INI and NNRTI at baseline, respectively, while participants before switching received a median number of 3 (IQR: 2–4) cART lines. 74.1% started LA according to their wish, and 51.8% coming from a dual oral cART (either dolutegravir/lamivudine or dolutegravir/rilpivirine).During a median time of 22 (IQR: 13–26) months of follow-up, 54 (11.1%) people had TD (incidence of TD was 6.24 person-months of follow-up). Figure 1 shows KM curve for TD. Most people discontinued to side effects (31, 6.4%), while 7 (1.4%) due to virological failure. Among these 71.4% reported major resistance mutations both to INI and NNRTI and were switched darunavir/cobicistat/tenofovir alafenamide/emtricitabine. The remaining 28.6% came back to the previous oral regimen. When multivariable analysis was performed, age, years living with HIV, CD4/CD8 ratio, and BMI were significantly associated with TD. Also, we detected that numbers of previous antiretroviral regimens and black-African ethnicity were significantly associated with VF.Abstract OC34 Figure 1ConclusionWhile the regimen demonstrated overall effectiveness, TD was observed in a specific subset of individuals, primarily due to side effects, with a smaller proportion experiencing VF. Factors we detected as associated with both TD and VF underscore the importance of personalized people selection and close monitoring to optimize long-acting ART outcomes. Further studies are warranted to refine strategies for mitigating treatment failure and improving regimen persistence.

• Publisher: BMJ Publishing Group LTD
• Subject: Cohort analysis / HIV / Human immunodeficiency virus / Morbidity / Regression analysis / Side effects / Virology