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Durability of Dolutegravir-Based Regimens: A 5-Year Prospective Observational Study

2021; Mary Ann Liebert, Inc.; Volume: 35; Issue: 9 Linguagem: Inglês

10.1089/apc.2021.0089

1557-7449

Lucia Taramasso, Andrea De Vito, Elena Ricci, Giancarlo Orofino, Nicola Squillace, Barbara Menzaghi, Chiara Molteni, Roberto Gulminetti, Giuseppe Vittorio De Socio, Giovanni Francesco Pellicanò, Eleonora Sarchi, Benedetto Maurizio Celesia, Leonardo Calza, Stefano Rusconi, Laura Valsecchi, Canio Martinelli, Antonio Cascio, Paolo Maggi, Francesca Vichi, Goffredo Angioni, Giuliana Guadagnino, Giovanni Cenderello, Chiara Dentone, Alessandra Bandera, Katia Falasca, Paolo Bonfanti, Antonio Di Biagio, Giordano Madeddu, Paolo Bonfanti, Antonio Di Biagio, Elena Ricci, Eleonora Sarchi, Guido Chichino, Cesare Bolla, Chiara Bellacosa, Gioacchino Angarano, Annalisa Saracino, Leonardo Calza, Barbara Menzaghi, Maddalena Farinazzo, Goffredo Angioni, Giuseppe Bruno, Benedetto Maurizio Celesia, Katia Falasca, Antonio Mastroianni, Giuliana Guadagnino, Francesca Vichi, E Salomoni, Canio Martinelli, Antonio Di Biagio, Chiara Dentone, Lucia Taramasso, Matteo Bassetti, Giovanni Cenderello, Chiara Molteni, Stefania Piconi, Giovanni Francesco Pellicanò, Giuseppe Nunnari, Laura Valsecchi, Laura Cordier, S. Parisini, Giuliano Rizzardini, Stefano Rusconi, Federico Conti, Alessandra Bandera, Andrea Gori, Davide Motta, Massimo Puoti, Paolo Bonfanti, Nicola Squillace, Guglielmo Marco Migliorino, Paolo Maggi, Salvatore Martini, Antonio Cascio, Marcello Trizzino, Roberto Gulminetti, Layla Pagnucco, Giuseppe Vittorio De Socio, Marco Nofri, Daniela Francisci, Donatella Cibelli, Giustino Parruti, Giordano Madeddu, M. Mameli, Giancarlo Orofino, Marta Guastavigna,

HIV Research and Treatment

This study evaluates the frequency and causes of dolutegravir (DTG) discontinuation along 5 years of follow-up, in both antiretroviral treatment (ART)-naive and experienced people living with HIV (PLWH). This is a prospective multi-center cohort study enrolling PLWH on DTG from July 2014 until November 2020. DTG-durability was investigated using the Kaplan–Meier survival curve. The Cox proportional-hazards model was used for estimating the hazard ratio (HR) of DTG discontinuation for any cause, and for adverse events (AEs). Nine hundred sixty-three PLWH were included, 25.3% were women and 28.0% were ART-naive. Discontinuations for any causes were 10.1 [95% confidence interval (95% CI) 8.9–11.5] per 100 person-years, similar in most regimens, with the apparent exception of tenofovir alafenamide/emtricitabine+DTG (p < 0.0001). In the multivariable Cox regression model, non-Caucasian ethnicity, age ≥50 years, and lower estimated glomerular filtration rate (eGFR) were associated with a higher probability of DTG interruption. The incidence rate of virological failure was 0.4 (95% CI 0.2–0.7) per 100 person-years, while the estimated discontinuation rate for AEs was 4.0 (3.2–4.9) per 100 person-years. Thirty-four DTG interruptions were due to grade ≥3 events (10 central nervous system, 6 hypersensitivity, 3 renal, 3 myalgia/asthenia, 3 abdominal pain, 2 gastrointestinal, and 7 other events). People with lower body mass index, age ≥50 years, and lower eGFR were at higher risk of AEs, while dual combinations were protective (HR 0.41 compared with abacavir/lamivudine/DTG, 95% CI 0.22–0.77). In this prospective observational study, we found high DTG durability and a low rate of virological failures. Dual therapies seemed protective toward AEs and might be considered, when feasible, a suitable option to minimize drug interactions and improve tolerability.