Effectiveness and predictors of treatment discontinuation of long-acting cabotegravir/rilpivirine in virologically suppressed people with HIV: real-life data from the Icona Cohort
Roberta Gagliardini, S De Benedittis, Alessandro Tavelli, Giuseppe Lapadula, Valentina Mazzotta, Elena Bruzzesi, Adriana Cervo, Giorgia Carrozzo, Annalisa Saracino, Stefano Rusconi, Giulia Marchetti, Francesca Ceccherini‐Silberstein, Andrea Antinori, Antonella d’Arminio Monforte, Camilla Muccini, Antonella d’Arminio Monforte, Andrea Antinori, Spinello Antinori, Antonella Castagna, Roberto Cauda, Giampaolo Perri, Enrico Girardi, R Iardino, Adriano Lazzarin, Giulia Marchetti, C Mussini, Eugenia Quirós-Roldán, Loredana Sarmati, Barbara Suligoi, F von Schloesser, P. Viale, Antonella d’Arminio Monforte, Andrea Antinori, Antonella Castagna, Francesca Ceccherini‐Silberstein, Antonella Cingolani, Alessandro Cozzi‐Lepri, Antonio Di Biagio, Enrico Girardi, Andrea Gori, Sergio Lo Caputo, G Marchetti, Franco Maggiolo, C Mussini, Massimo Puoti, Carlo Federico Perno, Carlo Torti, Andrea Antinori, Alessandra Bandera, Stefano Bonora, Andrea Calcagno, Diana Canetti, Antonella Castagna, Francesca Ceccherini‐Silberstein, A Cervo, Antonella Cingolani, Paola Cinque, Alessandro Cozzi‐Lepri, Antonella d’Arminio Monforte, Antonio Di Biagio, Roberta Gagliardini, A Giacomelli, Enrico Girardi, Nicola Gianotti, Andrea Gori, Giovanni Guaraldi, Simone Lanini, Giuseppe Lapadula, Miriam Lichtner, Alessia Lai, Sergio Lo Caputo, Giordano Madeddu, Franco Maggiolo, Vincenzo Malagnino, G Marchetti, Annalisa Mondi, Valentina Mazzotta, C Mussini, Silvia Nozza, Carlo Federico Perno, Stefania Piconi, Carmela Pinnetti, Massimo Puoti, Eugenia Quirós-Roldán, Roberto Rossotti, Stefano Rusconi, Maria Mercedes Santoro, Annalisa Saracino, Loredana Sarmati, Vincenzo Spagnuolo, Nicola Squillace, Valentina Svicher, Lucia Taramasso, Carlo Torti, Alessandra Vergori, Alessandro Cozzi‐Lepri, S De Benedittis, Iuri Fanti, M Giotta, Cécilia Marelli
Abstract
BACKGROUND: Phase 3 studies have shown long-acting (LA) cabotegravir/rilpivirine to be effective and tolerable as maintenance therapy in people with HIV (PWH). However, real-life data on their effectiveness are limited. METHODS: All PWH enrolled in the Icona Cohort who started LA cabotegravir/rilpivirine with HIV-RNA < 50 copies/mL were included. Times to treatment discontinuation (TD) and to virological failure (VF50, two consecutive HIV-RNA >50 copies/mL or one >1000 copies/mL followed by ART switch) were estimated by the Kaplan-Meier method. Cox regression models, adjusted for age, sex and mode of HIV transmission and stratified by the centre, were employed. RESULTS: Overall, 583 PWH started LA cabotegravir/rilpivirine. Six VF50 were observed, with a 1 year estimated cumulative probability of virological failure of 1.2% (95% CI, 0.5%-3.0%). Resistance-associated mutations for rilpivirine and cabotegravir were detected in 3/4 and 4/4 participants with VF50, respectively, for which the genotypic resistance test was performed.The 1 year cumulative probability of TD was 11.4% (95% CI, 8.6%-14.9%), mainly caused by toxicity/adverse events (73.2%). Multivariable analysis identified heterosexual intercourse and IV drug use as significant risk factors for TD compared with MSM. CONCLUSIONS: This analysis demonstrated the short-term effectiveness of cabotegravir/rilpivirine in a real-life setting showing minimal incidence of virological failure but a notable probability of discontinuation due to toxicity or adverse events.