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|Autori interni:||Di Giambenedetto, Simona |
De Luca, Andrea
|Titolo:||Safety and feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors + atazanavir/ritonavir with virological suppression (Atazanavir and Lamivudine for treatment Simplification, AtLaS pilot study)|
|Autori:||Di Giambenedetto, Simona; Fabbiani, Massimiliano; Colafigli, Manuela; Ciccarelli, Nicoletta; Farina, S; Sidella, Letizia; D'Avino, Alessandro; Mondi, Annalisa; Cingolani, Antonella; Tamburrini, Enrica; Murri, Rita; Navarra, Pierluigi; Cauda, Roberto; De Luca, Andrea|
|Digital Object Identifier (DOI):||10.1093/jac/dkt007|
|Data di pubblicazione:||2013|
|Abstract:||OBJECTIVES: To explore 48 week safety and efficacy of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients with virological suppression on a stable atazanavir/ritonavir-based standard triple regimen. METHODS: This was a single-arm pilot study, enrolling 40 patients on atazanavir/ritonavir + two nucleos(t)ide reverse transcriptase inhibitors (NRTIs), without previous treatment failure, with HIV-RNA <50 copies/mL for >3 months and CD4 >200 cells/mm(3). At baseline, patients were switched to 300/100 mg of atazanavir/ritonavir + 300 mg of lamivudine once daily. Laboratory parameters, atazanavir plasma levels, self-reported adherence, quality of life, neurocognitive performance, bone composition and body fat distribution were monitored. Virological failure was defined as HIV-RNA >50 copies/mL on two consecutive determinations or a single level >1000 copies/mL. RESULTS: After 48 weeks, 4/40 (10%) regimen discontinuations occurred: 1 death (brain haemorrhage), 1 study withdrawal (inadequate atazanavir plasma levels), 1 re-induction with two NRTIs due to pregnancy and 1 virological failure without development of resistance. Seven moderate to severe adverse events were recorded (including four renal colics, possibly treatment-related) in six patients. At week 48, increases in total (mean change +17 mg/dL, P = 0.001), high-density lipoprotein (+6 mg/dL, P < 0.001) and low-density lipoprotein (+8 mg/dL, P = 0.052) cholesterol were observed. The glomerular filtration rate improved (+7 mL/min/1.73 m(2), P < 0.001), as did scores exploring self-reported physical and mental health (+11, P = 0.009 and +13, P < 0.001 on a 0-100 scale), neuropsychological performance (-1 pathological task, P = 0.002) and total bone mineral density (+0.03 g/cm(2), P = 0.026). There were no significant changes in CD4 cell count, bilirubin, atazanavir plasma levels, adherence and body fat distribution over time. CONCLUSIONS: Simplification to atazanavir/ritonavir + lamivudine was apparently safe and associated with rare virological failure, without resistance selection. This strategy deserves further investigation in a randomized trial.|
|Rivista:||JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY|
|Citazione:||Di Giambenedetto, S., Fabbiani, M., Colafigli, M., Ciccarelli, N., Farina, S., Sidella, L., D'avino, A., Mondi, A., Cingolani, A., Tamburrini, E., Murri, R., Navarra, P., Cauda, R., De Luca, A., Safety and feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors + atazanavir/ritonavir with virological suppression (Atazanavir and Lamivudine for treatment Simplification, AtLaS pilot study), <<JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY>>, 2013; (Gennaio): N/A-N/A. [doi:10.1093/jac/dkt007] [http://hdl.handle.net/10807/40556]|
|Appare nelle tipologie:||Articolo in rivista, Nota a sentenza|
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