To investigate the long-term safety and efficacy of a treatment switch to dual ART with atazanavir/ritonavir + lamivudine versus continuing a standard regimen with atazanavir/ritonavir + 2NRTI in virologically suppressed patients.
Objectives: To investigate the long-term safety and efficacy of a treatment switch to dual ART with atazanavir/ ritonavir ! lamivudine versus continuing a standard regimen with atazanavir/ritonavir ! 2NRTI in virologically suppressed patients. Methods: ATLAS-M is a 96week open-label, randomized, non-inferiority (margin #12%) trial enrolling HIV-infected adults on atazanavir/ritonavir!2NRTI, with stable HIV-RNA ,50copies/mL and CD4 counts .200 cells/mm3. At baseline, patients were randomized 1:1 to switch to atazanavir/ritonavir ! lamivudine or to continue the previous regimen. Here, we report the 96 week efficacy and safety data. The study was registered with ClinicalTrials.gov, number NCT01599364. Results: Overall, 266 subjects were enrolled (133 in each arm). At 96 weeks, in the ITT population, patients free of treatment failure totalled 103 (77.4%) with atazanavir/ritonavir ! lamivudine and 87 (65.4%) with triple ther- apy (difference !12.0%, 95% CI !1.2/!22.8, P " 0.030), demonstrating the superiority of dual therapy. Two (1.5%) and 9 (6.8%) virological failures occurred in the dual-therapy arm and the triple-therapy arm, respect- ively, without development of resistance to any study drug. Clinical adverse events occurred at similar rates in both arms. A higher frequency of grade 3–4 hyperbilirubinemia (66.9% versus 50.4%, P " 0.006) and hypertrigly- ceridaemia (6.8% versus 1.5%, P " 0.031) occurred with dual therapy, although this never led to treatment dis- continuation. A significant improvement in renal function and lumbar spine bone mineral density occurred in the dual-therapy arm. The evolution of CD4, HIV-DNA levels and neurocognitive performance was similar in both arms. Conclusions: In this randomized study, a treatment switch to atazanavir/ritonavir ! lamivudine was superior over the continuation of atazanavir/ritonavir ! 2NRTI in virologically suppressed patients, with a sustained bene- fit in terms of improved renal function and bone mineral density.
Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial / Fabbiani, Massimiliano; Gagliardini, Roberta; Ciccarelli, Nicoletta; Quiros Roldan, Eugenia; Latini, Alessandra; D'Ettorre, Gabriella; Antinori, Andrea; Castagna, Antonella; Orofino, Giancarlo; Francisci, Daniela; Chinello, Pierangelo; Madeddu, Giordano; Grima, Pierfrancesco; Rusconi, Stefano; Del Pin, Barbara; Lombardi, Francesca; D'Avino, Alessandro; Focà, Emanuele; Colafigli, Manuela; Cauda, Roberto; Di Giambenedetto, Simona; De Luca, Andrea; ATLAS-M Study, Group. - In: JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY. - ISSN 0305-7453. - STAMPA. - 73:7(2018), pp. 1955-1964. [10.1093/jac/dky123]
Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial
d'Ettorre, Gabriella;LOMBARDI, Francesca;DE LUCA, ANDREA;Mezzaroma Ivano
2018
Abstract
Objectives: To investigate the long-term safety and efficacy of a treatment switch to dual ART with atazanavir/ ritonavir ! lamivudine versus continuing a standard regimen with atazanavir/ritonavir ! 2NRTI in virologically suppressed patients. Methods: ATLAS-M is a 96week open-label, randomized, non-inferiority (margin #12%) trial enrolling HIV-infected adults on atazanavir/ritonavir!2NRTI, with stable HIV-RNA ,50copies/mL and CD4 counts .200 cells/mm3. At baseline, patients were randomized 1:1 to switch to atazanavir/ritonavir ! lamivudine or to continue the previous regimen. Here, we report the 96 week efficacy and safety data. The study was registered with ClinicalTrials.gov, number NCT01599364. Results: Overall, 266 subjects were enrolled (133 in each arm). At 96 weeks, in the ITT population, patients free of treatment failure totalled 103 (77.4%) with atazanavir/ritonavir ! lamivudine and 87 (65.4%) with triple ther- apy (difference !12.0%, 95% CI !1.2/!22.8, P " 0.030), demonstrating the superiority of dual therapy. Two (1.5%) and 9 (6.8%) virological failures occurred in the dual-therapy arm and the triple-therapy arm, respect- ively, without development of resistance to any study drug. Clinical adverse events occurred at similar rates in both arms. A higher frequency of grade 3–4 hyperbilirubinemia (66.9% versus 50.4%, P " 0.006) and hypertrigly- ceridaemia (6.8% versus 1.5%, P " 0.031) occurred with dual therapy, although this never led to treatment dis- continuation. A significant improvement in renal function and lumbar spine bone mineral density occurred in the dual-therapy arm. The evolution of CD4, HIV-DNA levels and neurocognitive performance was similar in both arms. Conclusions: In this randomized study, a treatment switch to atazanavir/ritonavir ! lamivudine was superior over the continuation of atazanavir/ritonavir ! 2NRTI in virologically suppressed patients, with a sustained bene- fit in terms of improved renal function and bone mineral density.File | Dimensione | Formato | |
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