Effectiveness and predictors of treatment discontinuation of long-acting cabotegravir/rilpivirine in virologically suppressed people with HIV: real-life data from the Icona Cohort

Gagliardini R.;De Benedittis S.;Tavelli A.;Lapadula G.;Mazzotta V.;Bruzzesi E.;Cervo A.;Carrozzo G.;Saracino A.;Rusconi S.;Marchetti G.;Ceccherini-Silberstein F.;Antinori A.;d'Arminio Monforte A.;Muccini C.;d'Arminio Monforte A.;Cauda R.;Di Perri G.;Iardino R.;Lazzarin A.;Marchetti G. C.;Quiros-Roldan E.;Sarmati L.;Suligoi B.;von Schloesser F.;Viale P.;Antinori A.;Castagna A.;Ceccherini-Silberstein F.;Cingolani A.;Cozzi-Lepri A.;Di Biagio A.;Gori A.;Lo Caputo S.;Marchetti G.;Maggiolo F.;Puoti M.;Perno C. F.;Torti C.;Bandera A.;Bonora S.;Calcagno A.;Canetti D.;Cervo A.;Cinque P.;Gagliardini R.;Giacomelli A.;Gianotti N.;Guaraldi G.;Lanini S.;Lapadula G.;Lichtner M.;Lai A.;Madeddu G.;Malagnino V.;Mondi A.;Mazzotta V.;Mussini C.;Nozza S.;Piconi S.;Pinnetti C.;Quiros Roldan E.;Rossotti R.;Rusconi S.;Santoro M. M.;Saracino A.;Spagnuolo V.;Squillace N.;Svicher V.;Taramasso L.;Torty C.;Vergori A.;De Benedittis S.;Fanti I.;Giotta M.;Marelli C.;Rodano A.;Tavelli A.;Cernuschi M.;Cosmaro L.;Perziano A.;Calvino V.;Russo D.;Farinella M.;Policek N.;Del Negro V. L.;Augello M.;Carrara S.;Graziano S.;Prota G.;Truffa S.;Vincenti D.;Rovito R.;Sadeghi H.;Giacometti A.;Costantini A.;Barocci V.;Saracino A.;Santoro C.;Milano E.;Comi L.;Suardi C.;Viale P.;Badia L.;Cretella S.;Erne E. M.;Pieri A.;Quiros Roldan E.;Foca E.;Menzaghi B.;Abeli C.;Chessa L.;Pes F.;Maggi P.;Alessio L.;Nunnari G.;Celesia B. M.;Vecchiet J.;Falasca K.;Pan A.;Dal Zoppo S.;Segala D.;Bartalesi F.;Costa C.;Lo Caputo S.;Ferrara S.;Bassetti M.;Pontali E.;Blanchi S.;Bobbio N.;Del Borgo C.;Marocco R.;Mancarella G.;Piconi S.;Molteni C.;Rusconi S.;Canavesi G.;Pellicano G.;Marchetti G.;Antinori S.;Rizzardini G.;Puoti M.;Castagna A.;Bandera A.;Bono V.;Cossu M. V.;Giacomelli A.;Lolatto R.;Moioli M. C.;Pezzati L.;Diotallevi S.;Tincati C.;Mussini C.;Menozzi M.;Bonfanti P.;Lapadula G.;Sangiovanni V.;Gentile I.;Esposito V.;Coppola N.;Fusco F. M.;Di Filippo G.;Rizzo V.;Sangiovanni N.;Martini S.;Cattelan A. M.;Leoni D.;Cascio A.;Trizzino M.;Francisci D.;Schiaroli E.;Parruti G.;Sozio F.;Messeri D.;Bonelli S. I.;Lazzaretti C.;Corsini R.;Antinori A.;Cauda R.;Mastroianni C.;Sarmati L.;Latini A.;Cingolani A.;Mastrorosa I.;Lamonica S.;Capozzi M.;Camici M.;Mezzaroma I.;Rivano Capparuccia M.;Iaiani G.;Stingone C.;Gianserra L.;Paulicelli J.;Plazzi M. M.;d'Ettore G.;Fusto M.;Lichtner M.;Coledan I.;Madeddu G.;De Vito A.;Fabbiani M.;Montagnani F.;Franco A.;Fontana Del Vecchio R.;Francisci D.;Di Giuli C.;Orofino G. C.;Calleri G.;Di Perri G.;Bonora S.;Accardo G.;Tascini C.;Londero A.;Battagin G.;Nicole S.;Starnini G.;Dell'Isola S.

2025-01-01

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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.