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
Authors: d’Arminio Monforte Antonella , Tavelli Alessandro , Di Biagio Antonio , Sarmati Loredana , Marchetti Giulia C , Bai Francesca , Cingolani Antonella , Quiros Roldan Eugenio , Mussini Cristina , Lichtner Miriam , Vergori Alessandra , Piconi Stefania , Orofino Giancarlo , Fusco Francesco Maria , Bandera Alessandra , Nozza Silvia , Castagna Antonella , Antinori Andrea ,   the ICONA Foundation Study Group, 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 
Published: April 2024

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 &gt;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 &gt;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.