Arturo Ciccullo1,2, Vanni Borghi3, Andrea Giacomelli4, Maria Vittoria Cossu5, Gaetana Sterrantino6, Alessandra Latini7, Andrea Giacometti8, Andrea De Vito9, William Gennari10, Giordano Madeddu9, Amedeo Capetti5, Gabriella d'Ettorre11, Cristina Mussini3, Stefano Rusconi4, Simona Di Giambenedetto2,12, Gianmaria Baldin12,13. 1. UOC Malattie Infettive, P.O. San Salvatore, L'Aquila, Italy. 2. Catholic University of the Sacred Heart, Rome, Italy. 3. Azienda Ospedaliero Universitaria di Modena, Clinica Malattie Infettive e Tropicali, Modena, Italy. 4. Infectious Diseases Unit, DIBIC Luigi Sacco, University of Milan, Milan, Italy. 5. Division of Infectious Diseases, Department of Infectious Diseases, Luigi Sacco University Hospital, Milan, Italy. 6. Infectious Diseases Unit, Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy. 7. Infectious Dermatology and Allergology Unit, IFO S. Gallicano Institute (IRCCS), Rome, Italy. 8. Clinic of Infectious Diseases, Department of Biomedical Sciences and Public Health, Polytechnic University of Marche, Ancona. Italy. 9. Unit of Infectious Diseases, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy. 10. Azienda Ospedaliero Universitaria di Modena Laboratorio di Microbiologia e Virologia, Modena, Italy. 11. Department of Public Health and Infectious Diseases, Azienda Policlinico Umberto I, Rome, Italy. 12. UOC Malattie Infettive, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; and. 13. Mater Olbia Hospital, Olbia, Italy.
Abstract
BACKGROUND: Results from clinical trials and observational studies suggest that dolutegravir plus lamivudine could be an effective and well-tolerated option for simplification in HIV-1-positive patients. We aimed to assess long-time efficacy and safety in our multicenter cohort. METHODS: This was a retrospective study enrolling HIV-1-infected, virologically suppressed patients switching to dolutegravir + lamivudine. We performed survival analysis to evaluate time to virological failure (VF, defined by a single HIV-RNA ≥1000 copies/mL or by 2 consecutive HIV-RNA ≥ 50 copies/mL) and treatment discontinuation (defined as the interruption of either 3TC or dolutegravir), assessing predictors via Cox regression analyses. RESULTS: Seven-hundred eighty-five patients were considered for the analysis: 554 were men (70.6%), with a median age of 52 years (interquartile range 45-58 years). Estimated probabilities of maintaining virological suppression at weeks 96, 144, and 240 were 97.7% (SD ±0.6), 96.9% (SD ±0.8), and 96.4% (SD ±0.9), respectively. A non-B HIV subtype (P = 0.014) and a previous VF (P = 0.037) resulted predictors of VF. We did not observe differences in probability of VF in people living with HIV with an M184V resistance mutation (P = 0.689); however, in a deeper analysis, M184V mutation was a predictor of VF (P = 0.038) in patients with time of virological suppression <88 months. Estimated probabilities of remaining on study regimen at 96, 144, and 240 weeks were 82.9% (SD ±1.4), 79.7% (SD ±1.6) and 74.3% (SD ±2.2), respectively. CONCLUSIONS: Our findings show the long-term efficacy and tolerability of dolutegravir plus lamivudine in virologically suppressed patients.
BACKGROUND: Results from clinical trials and observational studies suggest that dolutegravir plus lamivudine could be an effective and well-tolerated option for simplification in HIV-1-positive patients. We aimed to assess long-time efficacy and safety in our multicenter cohort. METHODS: This was a retrospective study enrolling HIV-1-infected, virologically suppressed patients switching to dolutegravir + lamivudine. We performed survival analysis to evaluate time to virological failure (VF, defined by a single HIV-RNA ≥1000 copies/mL or by 2 consecutive HIV-RNA ≥ 50 copies/mL) and treatment discontinuation (defined as the interruption of either 3TC or dolutegravir), assessing predictors via Cox regression analyses. RESULTS: Seven-hundred eighty-five patients were considered for the analysis: 554 were men (70.6%), with a median age of 52 years (interquartile range 45-58 years). Estimated probabilities of maintaining virological suppression at weeks 96, 144, and 240 were 97.7% (SD ±0.6), 96.9% (SD ±0.8), and 96.4% (SD ±0.9), respectively. A non-B HIV subtype (P = 0.014) and a previous VF (P = 0.037) resulted predictors of VF. We did not observe differences in probability of VF in people living with HIV with an M184V resistance mutation (P = 0.689); however, in a deeper analysis, M184V mutation was a predictor of VF (P = 0.038) in patients with time of virological suppression <88 months. Estimated probabilities of remaining on study regimen at 96, 144, and 240 weeks were 82.9% (SD ±1.4), 79.7% (SD ±1.6) and 74.3% (SD ±2.2), respectively. CONCLUSIONS: Our findings show the long-term efficacy and tolerability of dolutegravir plus lamivudine in virologically suppressed patients.