Long-term outcomes of bictegravir/emtricitabine/tenofovir alafenamide as first-line therapy and as switch strategy in virologically suppressed persons with HIV: data from the ICONA cohort
Author:
d’Arminio Monforte Antonella1, Tavelli Alessandro1, Di Biagio Antonio2ORCID, Sarmati Loredana3ORCID, Marchetti Giulia C4, Bai Francesca4, Cingolani Antonella5, Quiros Roldan Eugenio6, Mussini Cristina7, Lichtner Miriam8, Vergori Alessandra9ORCID, Piconi Stefania10, Orofino Giancarlo11, Fusco Francesco Maria12, Bandera Alessandra13, Nozza Silvia14ORCID, Castagna Antonella14, Antinori Andrea9, , d’Arminio Monforte A, Antinori A, Antinori S, Castagna A, Cauda R, Di Perri G, Girardi E, Iardino R, Lazzarin A, Marchetti G C, Mussini C, Quiros-Roldan E, Sarmati L, Suligoi B, von Schloesser F, Viale P, d’Arminio Monforte A, Antinori A, Castagna A, Ceccherini-Silberstein F, Cingolani A, Cozzi-Lepri A, Di Biagio A, Girardi E, Gori A, Lo Caputo S, Marchetti G, Maggiolo F, Mussini C, Puoti M, Perno C F, Torti C, Antinori A, Bai F, Bandera A, Bonora S, Calcagno A, Canetti D, Castagna A, Ceccherini-Silberstein F, Cervo A, Cingolani A, Cinque P, Cozzi-Lepri A, d’Arminio Monforte A, Di Biagio A, Gagliardini R, Giacomelli A, Girardi E, Gianotti N, Gori A, Guaraldi G, Lanini S, Lapadula G, Lichtner M, Lai A, Lo Caputo S, Madeddu G, Maggiolo F, Malagnino V, Marchetti G, Mondi A, Mazzotta V, Mussini C, Nozza S, Perno C F, Piconi S, Pinnetti C, Puoti M, Quiros Roldan E, Rossotti R, Rusconi S, Santoro M M, Saracino A, Sarmati L, Spagnuolo V, Squillace N, Svicher V, Taramasso L, Torti C, Vergori A, Cozzi-Lepri A, De Benedittis S, Fanti I, Giotta M, Rodano’ A, Tavelli A, Bove A, Cernuschi M, Cosmaro L, Errico M, Perziano A, Calvino V, Augello M, Carrara S, Graziano S, Prota G, Truffa S, Vincenti D, Rovito R, 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, Focà E, Minardi C, Menzaghi B, Abeli C, Chessa L, Pes F, Maggi P, Alessio L, Cacopardo B, Celesia B, Vecchiet J, Falasca K, Pan A, Dal Zoppo S, Segala D, Di Pietro M A, Costa C, Lo Caputo S, Ferrara S, Bassetti M, Pontali E, Blanchi S, Bobbio N, Mazzarello G, Lichtner M, Fondaco L, Piconi S, Molteni C, Rusconi S, Canavesi G, Nunnari G, Pellicanò 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, Puzzolante C, 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, Colomba C, Francisci D, Schiaroli E, Parruti G, Sozio F, Blanc P, Bonelli S I, Lazzaretti C, Corsini R, Antinori A, Cauda R, Mastroianni C, Sarmati L, Latini A, Cingolani A, Mazzotta V, Lamonica S, Capozzi M, Mondi A, Rivano Capparuccia M, Iaiani G, Stingone C, Gianserra L, Paulicelli J, Plazzi M M, d’Ettore G, Fusto M, Coledan I, Madeddu G, De Vito A, Fabbiani M, Montagnani F, Franco A, Fontana Del Vecchio R, Pasticci B M, Di Giuli C, Orofino G C, Calleri G, Di Perri G, Bonora S, Accardo G, Tascini C, Londero A, Manfrin V, Battagin G, Starnini G, Farinacci D
Affiliation:
1. ICONA Foundation , Via A di Rudinì, 8–20142 Milan , Italy 2. Department of Health Sciences IRCCS Ospedale Policlinico San Martino, University of Genova , Genova , Italy 3. Department of Medicine of Systems, University of Rome Tor Vergata, Policlinico Tor Vergata , Rome , Italy 4. Department of Health Sciences, ASST Santi Paolo e Carlo, Clinic of Infectious Diseases, University of Milan , Milan , Italy 5. Fondazione Policlinico Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore , Rome , Italy 6. Department of Clinical and Experimental Sciences, Unit of Infectious and Tropical Diseases, University of Brescia, ASST Spedali Civili di Brescia , Brescia , Italy 7. Clinic of Infectious Diseases, University Hospital of Modena, University of Modena and Reggio Emilia , Modena , Italy 8. Department of Public Health and Infectious Diseases, Sapienza University, Infectious Diseases Unit, Santa Maria Goretti Hospital , Latina , Italy 9. Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS , Rome , Italy 10. Infectious Diseases Unit, Alessandro Manzoni Hospital, ASST Lecco , Lecco , Italy 11. Unit of Infectious Diseases, Amedeo di Savoia Hospital , Torino , Italy 12. UOC Infezioni Sistemiche e dell’Immunodepresso, AORN Ospedali dei Colli, P.O. “D. Cotugno” , Naples , Italy 13. Centre for Multidisciplinary Research in Health Science (MACH), University of Milano, Infectious Diseases Unit, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico , Milan , Italy 14. Clinic of Infectious Diseases, San Raffaele Scientific Institute, Vita-Salute San Raffaele University , Milan , Italy
Abstract
Abstract
Objectives
To assess the effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) among people poorly represented in clinical trials and potentially at higher risk of suboptimal response to ART.
Methods
Observational cohort study on persons with HIV (PWH) enrolled in ICONA who started BIC/FTC/TAF as initial therapy or as switching regimen while virologically suppressed. Primary endpoint was time to treatment failure (TF): new AIDS/death or virological failure (VF) or discontinuation for toxicity/failure. Secondary endpoints were time to treatment discontinuation for toxicity (TDT) and to VF. Groups of interest were those aged >50 years, female sex, and advanced HIV disease at first ART start. Probability of the events overall and according to groups and adjusted HR for every endpoint were calculated by Kaplan–Meier curves and Cox regression models.
Results
Nine hundred and thirty-three ART-naive and 1655 ART-experienced PWH initiated BIC/FTC/TAF. Over a median follow-up of 69.8 weeks, 89 (9.6%) PWH at their first regimen experienced TF. PWH aged >50 years had 1.83-fold (95% CI: 1.19–2.83) higher risk of TF; PWH with advanced HIV disease had 2.21-fold (95% CI: 1.53–3.82) higher risk; there were no differences in TF according to sex.
Over a median follow-up of 146.3 weeks, 109 (6.6%) out of 1655 switching PWH experienced TF; no differences were found in the risk of TF, TDT and VF according to groups of interest.
Conclusions
Overall, BIC/FTC/TAF is well tolerated and virologically effective in the real-world scenario for ART-naive and -experienced PWH. Older ART-naive PWH and those with advanced HIV disease may respond less well as the burden of diseases might compromise treatment efficacy.
Funder
Icona Foundation ViiV Healthcare Merck Sharpe & Dohme Gilead Sciences
Publisher
Oxford University Press (OUP)
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