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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), <<The Journal of antimicrobial chemotherapy>>, 2013; (Gennaio): N/A-N/A. [doi:10.1093/jac/dkt007] [http://hdl.handle.net/10807/40556]

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/10807/40556

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
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)
Lingua: ENG
Data di pubblicazione: 2013
MIUR : MED/17 - Malattie Infettive
Area tematica ERC: Pharmacology, pharmacogenomics, drug discovery and design, drug therapy
Abstract in inglese: OBJECTIVES: To explore 48 week safety and efficacy of treatment simplification to atazanavir/rito...navir + 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.
Titolo della pubblicazione periodica: JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
DOI: 10.1093/jac/dkt007
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), <<The Journal of antimicrobial chemotherapy>>, 2013; (Gennaio): N/A-N/A. [doi:10.1093/jac/dkt007] [http://hdl.handle.net/10807/40556]

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