Gianmaria Baldin1, Arturo Ciccullo2, Stefano Rusconi3, Amedeo Capetti4, Gaetana Sterrantino5, Manuela Colafigli6, Gabriella d'Ettorre7, Andrea Giacometti8, Maria Vittoria Cossu4, Alberto Borghetti9, William Gennari10, Cristina Mussini11, Vanni Borghi11, Simona Di Giambenedetto12. 1. Institute of Infectious Diseases, Catholic University of the Sacred Heart, Rome, Italy; Mater Olbia Hospital, Olbia, Italy. 2. Institute of Infectious Diseases, Catholic University of the Sacred Heart, Rome, Italy. Electronic address: arturo.ciccullo@gmail.com. 3. Infectious Diseases Unit, DIBIC Luigi Sacco, University of Milan, Milan, Italy. 4. Division of Infectious Diseases, Department of Infectious Diseases, Luigi Sacco University Hospital, Milan, Italy. 5. Infectious Diseases Unit, Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy. 6. Infectious Dermatology and Allergology Unit, IFO S. Gallicano Institute (IRCCS), Rome, Italy. 7. Department of Public Health and Infectious Diseases, Azienda Policlinico Umberto I, Rome, Italy. 8. Clinic of Infectious Diseases, Department of Biomedical Sciences and Public Health, Polytechnic University of Marche, Ancona, Italy. 9. Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Malattie Infettive, Rome, Italy. 10. Azienda Ospedaliero Universitaria di Modena Laboratorio di Microbiologia e Virologia, Modena, Italy. 11. Azienda Ospedaliero Universitaria di Modena, Clinica Malattie Infettive e Tropicali, Modena, Italy. 12. Institute of Infectious Diseases, Catholic University of the Sacred Heart, Rome, Italy; Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Malattie Infettive, Rome, Italy.
Abstract
BACKGROUND: Results from clinical trials and observational studies suggest that lamivudine plus dolutegravir (3TC+DTG) could be an effective and tolerated option for simplification in human immunodeficiency virus (HIV)-1-positive patients. MATERIALS AND METHODS: This observational study enrolled HIV-1-infected, virologically suppressed patients switching to 3TC+DTG. Kaplan-Meyer survival analysis was performed to evaluate time to virological failure (VF; defined by a single HIV-RNA determination ≥1000 copies/mL or by two consecutive HIV-RNA determinations ≥50 copies/mL) and time to treatment discontinuation (TD; defined as interruption of either 3TC or DTG), Cox regression was performed to assess predictors, and linear mixed model was performed for repeated measures to measure changes in immunological and metabolic parameters. RESULTS: Five hundred and fifty-six patients were eligible for analysis. Their median CD4+ count at baseline was 668 cells/mm3 and median time of virological suppression was 88 months. Estimated probabilities of maintaining virological suppression at 96 and 144 weeks of follow-up were 97.5% [standard deviation (SD) 0.8] and 96.5% (SD 1.0), respectively. Years since HIV diagnosis was the only predictor of VF. In patients with time of virological suppression <88 months, the rate of VF was higher in the presence of the M184V mutation. Estimated probabilities of remaining on 3TC+DTG at 96 and 144 weeks of follow-up were 79.2% (SD 1.9) and 75.2% (SD 2.2), respectively. A significant increase in CD4 cell count (+44 cells/mm3, P=0.015), CD4/CD8 ratio (+0.10, P=0.002) and high-density lipoprotein cholesterol (+5.4 mg/dL, P=0.036) was found at 144 weeks of follow-up; meanwhile, total cholesterol (-9.1 mg/dL, P=0.007) and triglycerides (-2.7, P=0.009) decreased significantly. CONCLUSIONS: These findings confirm the efficacy and tolerability of 3TC+DTG in virologically suppressed patients.
BACKGROUND: Results from clinical trials and observational studies suggest that lamivudine plus dolutegravir (3TC+DTG) could be an effective and tolerated option for simplification in human immunodeficiency virus (HIV)-1-positive patients. MATERIALS AND METHODS: This observational study enrolled HIV-1-infected, virologically suppressed patients switching to 3TC+DTG. Kaplan-Meyer survival analysis was performed to evaluate time to virological failure (VF; defined by a single HIV-RNA determination ≥1000 copies/mL or by two consecutive HIV-RNA determinations ≥50 copies/mL) and time to treatment discontinuation (TD; defined as interruption of either 3TC or DTG), Cox regression was performed to assess predictors, and linear mixed model was performed for repeated measures to measure changes in immunological and metabolic parameters. RESULTS: Five hundred and fifty-six patients were eligible for analysis. Their median CD4+ count at baseline was 668 cells/mm3 and median time of virological suppression was 88 months. Estimated probabilities of maintaining virological suppression at 96 and 144 weeks of follow-up were 97.5% [standard deviation (SD) 0.8] and 96.5% (SD 1.0), respectively. Years since HIV diagnosis was the only predictor of VF. In patients with time of virological suppression <88 months, the rate of VF was higher in the presence of the M184V mutation. Estimated probabilities of remaining on 3TC+DTG at 96 and 144 weeks of follow-up were 79.2% (SD 1.9) and 75.2% (SD 2.2), respectively. A significant increase in CD4 cell count (+44 cells/mm3, P=0.015), CD4/CD8 ratio (+0.10, P=0.002) and high-density lipoprotein cholesterol (+5.4 mg/dL, P=0.036) was found at 144 weeks of follow-up; meanwhile, total cholesterol (-9.1 mg/dL, P=0.007) and triglycerides (-2.7, P=0.009) decreased significantly. CONCLUSIONS: These findings confirm the efficacy and tolerability of 3TC+DTG in virologically suppressed patients.
Authors: Anna Maria Geretti; Jose Luis Blanco; Anne Genevieve Marcelin; Carlo Federico Perno; Hans Jurgen Stellbrink; Dan Turner; Tuba Zengin Journal: Infect Dis Ther Date: 2022-08-01
Authors: Eric A Meyerowitz; Raffaele M Bernardo; Michelle D Collins-Ogle; Jonathan M Czeresnia; Cariane M Matos; Caroline Mullis; Heather B Root; Julián A Torres-Isasiga; Helen Tsai; Barry S Zingman Journal: Open Forum Infect Dis Date: 2022-04-15 Impact factor: 4.423
Authors: Josep M Llibre; Pedro E Cahn; Janet Lo; Tristan J Barber; Cristina Mussini; Berend J van Welzen; Beatriz Hernandez; Cynthia Donovan; Michelle Kisare; Myooran Sithamparanathan; Jean van Wyk Journal: Open Forum Infect Dis Date: 2022-02-10 Impact factor: 3.835