PMID- 34524918 OWN - NLM STAT- MEDLINE DCOM- 20211013 LR - 20211013 IS - 1557-7449 (Electronic) IS - 1087-2914 (Linking) VI - 35 IP - 9 DP - 2021 Sep TI - Durability of Dolutegravir-Based Regimens: A 5-Year Prospective Observational Study. PG - 342-353 LID - 10.1089/apc.2021.0089 [doi] AB - 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. FAU - Taramasso, Lucia AU - Taramasso L AUID- ORCID: 0000-0002-6622-6358 AD - Infectious Disease Clinic, IRCCS Policlinico San Martino Hospital, Genoa, Italy. FAU - De Vito, Andrea AU - De Vito A AD - Unit of Infectious and Tropical Diseases, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy. FAU - Ricci, Elena Delfina AU - Ricci ED AD - Fondazione ASIA Onlus, Buccinasco, Italy. FAU - Orofino, Giancarlo AU - Orofino G AD - Unit of Infectious Diseases, "Divisione A", Amedeo di Savoia Hospital, Torino, Italy. FAU - Squillace, Nicola AU - Squillace N AD - Infectious Diseases Clinic, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy. FAU - Menzaghi, Barbara AU - Menzaghi B AD - Unit of Infectious Diseases, ASST della Valle Olona, Busto Arsizio Hospital, Busto Arsizio, Italy. FAU - Molteni, Chiara AU - Molteni C AD - Infectious Disease Unit, Ospedale A. Manzoni, Lecco, Italy. FAU - Gulminetti, Roberto AU - Gulminetti R AD - Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy. FAU - De Socio, Giuseppe Vittorio AU - De Socio GV AD - Clinic of Infectious Diseases, Department of Medicine 2, Azienda Ospedaliera di Perugia, Santa Maria Hospital, Perugia, Italy. FAU - Pellicano, Giovanni Francesco AU - Pellicano GF AD - Unit of Infectious Diseases, Department of Human Pathology of the Adult and the Developmental Age 'G. Barresi', University of Messina, Messina, Italy. FAU - Sarchi, Eleonora AU - Sarchi E AD - Infectious Diseases Unit, SS. Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy. FAU - Celesia, Benedetto Maurizio AU - Celesia BM AD - Unit of Infectious Diseases, University of Catania, ARNAS Garibaldi, Catania, Italy. FAU - Calza, Leonardo AU - Calza L AD - Department of Medical and Surgical Sciences, Clinics of Infectious Diseases, S. Orsola-Malpighi Hospital, "Alma Mater Studiorum" University of Bologna, Bologna, Italy. FAU - Rusconi, Stefano AU - Rusconi S AD - Infectious Diseases Unit, Department of Biomedical and Clinical Sciences 'Luigi Sacco', Universita degli Studi di Milano, Milan, Italy. FAU - Valsecchi, Laura AU - Valsecchi L AD - Infectious Disease Unit (I Divisione), ASST Fatebenefratelli Sacco, Milan, Italy. FAU - Martinelli, Canio Vito AU - Martinelli CV AD - SOD Malattie Infettive e Tropicali AOU Careggi, Florence, Italy. FAU - Cascio, Antonio AU - Cascio A AD - Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy. FAU - Maggi, Paolo AU - Maggi P AD - Department of Infectious Disease, University of Campania Luigi Vanvitelli, Naples, Italy. FAU - Vichi, Francesca AU - Vichi F AD - Infectious Diseases Department, SOC 1, USLCENTROFIRENZE, Santa Maria Annunziata Hospital, Florence, Italy. FAU - Angioni, Goffredo AU - Angioni G AD - Infectious Diseases Unit, SS Trinita Hospital, Cagliari, Italy. FAU - Guadagnino, Giuliana AU - Guadagnino G AD - Department of Infectious and Tropical Diseases, St. Annunziata Hospital, Cosenza, Italy. FAU - Cenderello, Giovanni AU - Cenderello G AD - Infectious Diseases Department, Sanremo Hospital, Sanremo, Italy. FAU - Dentone, Chiara AU - Dentone C AD - Infectious Disease Clinic, IRCCS Policlinico San Martino Hospital, Genoa, Italy. FAU - Bandera, Alessandra AU - Bandera A AD - Infectious Disease Unit, Department of Internal Medicine, Fondazione IRCCS Ca' Granda, University of Milan, Ospedale Maggiore Policlinico, Milan, Italy. FAU - Falasca, Katia AU - Falasca K AD - Clinic of Infectious Diseases, Department of Medicine and Science of Aging, University 'G. d'Annunzio' Chieti-Pescara, Chieti, Italy. FAU - Bonfanti, Paolo AU - Bonfanti P AD - Infectious Diseases Clinic, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy. FAU - Di Biagio, Antonio AU - Di Biagio A AD - Infectious Diseases Clinic, Department of Health Sciences, University of Genoa, San Martino Hospital-IRCCS, Genoa, Italy. FAU - Madeddu, Giordano AU - Madeddu G AD - Unit of Infectious and Tropical Diseases, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy. CN - Behalf of the CISAI Study Group LA - eng PT - Journal Article PT - Observational Study PL - United States TA - AIDS Patient Care STDS JT - AIDS patient care and STDs JID - 9607225 RN - 0 (Anti-HIV Agents) RN - 0 (Heterocyclic Compounds, 3-Ring) RN - 0 (Oxazines) RN - 0 (Piperazines) RN - 0 (Pyridones) RN - DKO1W9H7M1 (dolutegravir) SB - IM MH - *Anti-HIV Agents/adverse effects MH - Cohort Studies MH - Female MH - *HIV Infections/drug therapy MH - Heterocyclic Compounds, 3-Ring MH - Humans MH - Middle Aged MH - Oxazines/therapeutic use MH - Piperazines MH - Prospective Studies MH - Pyridones OTO - NOTNLM OT - HIV OT - adverse events OT - dolutegravir OT - durability OT - safety OT - toxicity OT - virolgical failure FIR - Bonfanti, Paolo IR - Bonfanti P FIR - Di Biagio, Antonio IR - Di Biagio A FIR - Ricci, Elena IR - Ricci E FIR - Sarchi, E IR - Sarchi E FIR - Chichino, G IR - Chichino G FIR - Bolla, C IR - Bolla C FIR - Bellacosa, C IR - Bellacosa C FIR - Angarano, G IR - Angarano G FIR - Saracino, A IR - Saracino A FIR - Calza, L IR - Calza L FIR - Menzaghi, B IR - Menzaghi B FIR - Farinazzo, M IR - Farinazzo M FIR - Angioni, G IR - Angioni G FIR - Bruno, G IR - Bruno G FIR - Celesia, B M IR - Celesia BM FIR - Falasca, K IR - Falasca K FIR - Mastroianni, A IR - Mastroianni A FIR - Guadagnino, G IR - Guadagnino G FIR - Vichi, F IR - Vichi F FIR - Salomoni, E IR - Salomoni E FIR - Martinelli, C IR - Martinelli C FIR - Di Biagio, A IR - Di Biagio A FIR - Dentone, C IR - Dentone C FIR - Taramasso, L IR - Taramasso L FIR - Bassetti, M IR - Bassetti M FIR - Cenderello, G IR - Cenderello G FIR - Molteni, C IR - Molteni C FIR - Piconi, S IR - Piconi S FIR - Pellicano, G F IR - Pellicano GF FIR - Nunnari, G IR - Nunnari G FIR - Valsecchi, L IR - Valsecchi L FIR - Cordier, L IR - Cordier L FIR - Parisini, S IR - Parisini S FIR - Rizzardini, G IR - Rizzardini G FIR - Rusconi, S IR - Rusconi S FIR - Conti, F IR - Conti F FIR - Bandera, A IR - Bandera A FIR - Gori, A IR - Gori A FIR - Motta, D IR - Motta D FIR - Puoti, M IR - Puoti M FIR - Bonfanti, P IR - Bonfanti P FIR - Squillace, N IR - Squillace N FIR - Migliorino, G M IR - Migliorino GM FIR - Maggi, P IR - Maggi P FIR - Martini, S IR - Martini S FIR - Cascio, A IR - Cascio A FIR - Trizzino, M IR - Trizzino M FIR - Gulminetti, R IR - Gulminetti R FIR - Pagnucco, L IR - Pagnucco L FIR - De Socio, G V IR - De Socio GV FIR - Nofri, M IR - Nofri M FIR - Francisci, D IR - Francisci D FIR - Cibelli, D IR - Cibelli D FIR - Parruti, G IR - Parruti G FIR - Madeddu, G IR - Madeddu G FIR - Mameli, M S IR - Mameli MS FIR - Orofino, G IR - Orofino G FIR - Guastavigna, M IR - Guastavigna M EDAT- 2021/09/16 06:00 MHDA- 2021/10/14 06:00 CRDT- 2021/09/15 17:13 PHST- 2021/09/15 17:13 [entrez] PHST- 2021/09/16 06:00 [pubmed] PHST- 2021/10/14 06:00 [medline] AID - 10.1089/apc.2021.0089 [doi] PST - ppublish SO - AIDS Patient Care STDS. 2021 Sep;35(9):342-353. doi: 10.1089/apc.2021.0089.