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 ≥1,000 copies/mL or by two consecutive HIV-RNA ≥ 50 copies/mL) and treatment discontinuation (TD, defined as the interruption of either 3TC or DTG), assessing predictors via Cox regression analyses. Results: Seven-hundred eighty-five patients were considered for the analysis: 554 were males (70.6%), with a median age of 52 years (IQR 45-58). 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). 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 PLWHIV with a 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.
Five years with dolutegravir plus lamivudine as a switch strategy : much more than a positive finding / A. Ciccullo, V. Borghi, A. Giacomelli, M.V. Cossu, G. Sterrantino, A. Latini, A. Giacometti, A. De Vito, W. Gennari, G. Madeddu, A. Capetti, G. D'Ettorre, C. Mussini, S. Rusconi, S. Di Giambenedetto, G. Baldin. - In: JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES. - ISSN 1525-4135. - (2021 Aug 20). [Epub ahead of print] [10.1097/QAI.0000000000002787]
Five years with dolutegravir plus lamivudine as a switch strategy : much more than a positive finding
A. Giacomelli;S. Rusconi;
2021
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 ≥1,000 copies/mL or by two consecutive HIV-RNA ≥ 50 copies/mL) and treatment discontinuation (TD, defined as the interruption of either 3TC or DTG), assessing predictors via Cox regression analyses. Results: Seven-hundred eighty-five patients were considered for the analysis: 554 were males (70.6%), with a median age of 52 years (IQR 45-58). 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). 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 PLWHIV with a 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.File | Dimensione | Formato | |
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