Abstract OBJECTIVES: The AtLaS-M randomized trial showed that in patients with HIV-1 RNA <50 copies/mL on atazanavir/ritonavir + two NRTIs, switching to a dual therapy with atazanavir/ritonavir+lamivudine had superior efficacy as compared with continuing the previous triple therapy. This substudy was designed to evaluate at 48 weeks the impact of the dual therapy versus the three-drug atazanavir/ritonavir-based therapy on the HIV-1 cellular reservoir as reflected by the quantification of blood-associated HIV-1 DNA levels. METHODS: In a representative subset of 201 of 266 randomized patients (104 in the dual-therapy arm and 97 in the triple-therapy arm) total HIV-1 DNA levels in whole blood at baseline and after 48 weeks and factors associated with the HIV-1 DNA levels were evaluated. RESULTS: The mean baseline HIV-1 DNA levels (2.47 log 10 copies/10 6 leucocytes) were comparable between arms. A significant mean decrease between baseline and week 48 was observed: -0.069 log 10 copies/10 6 leucocytes in the dual-therapy arm ( P  =   0.046) and -0.078 in the triple-therapy arm ( P  =   0.011); the mean difference between arms was -0.009 ( P  =   0.842). Nadir CD4 count was inversely correlated with baseline HIV-1 DNA ( P  =   0.009); longer duration of ART and lower nadir CD4 correlated with a less prominent HIV-1 DNA decrease (both P  <   0.005). Higher baseline HIV-1 DNA was associated with residual viraemia at week 48 ( P  =   0.031). CONCLUSIONS: When compared with continuing three-drug therapy, atazanavir/ritonavir+lamivudine dual therapy resulted in a similar decline in HIV-1 DNA levels in patients with sustained virological suppression. These data support the safety of this simplified treatment strategy in terms of its effect on the cellular HIV-1 reservoir

Lombardi, F., Belmonti, S., Quiros Roldan, E., Latini, A., Castagna, A., D'ettorre, G., Gagliardini, R., Fabbiani, M., Cauda, R., De Luca, A., Di Giambenedetto, S., Evolution of blood-associated HIV-1 DNA levels after 48 weeks of switching to atazanavir/ritonavir+lamivudine dual therapy versus continuing triple therapy in the randomized AtLaS-M trial, <<JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY>>, 2017; (n/a): N/A-N/A. [doi:10.1093/jac/dkx068] [http://hdl.handle.net/10807/102550]

Evolution of blood-associated HIV-1 DNA levels after 48 weeks of switching to atazanavir/ritonavir+lamivudine dual therapy versus continuing triple therapy in the randomized AtLaS-M trial

Lombardi, Francesca
Primo
;
Belmonti, Simone
Secondo
;
Gagliardini, Roberta;Fabbiani, Massimiliano;Cauda, Roberto;De Luca, Andrea
Penultimo
;
Di Giambenedetto, Simona
Ultimo
2017

Abstract

Abstract OBJECTIVES: The AtLaS-M randomized trial showed that in patients with HIV-1 RNA <50 copies/mL on atazanavir/ritonavir + two NRTIs, switching to a dual therapy with atazanavir/ritonavir+lamivudine had superior efficacy as compared with continuing the previous triple therapy. This substudy was designed to evaluate at 48 weeks the impact of the dual therapy versus the three-drug atazanavir/ritonavir-based therapy on the HIV-1 cellular reservoir as reflected by the quantification of blood-associated HIV-1 DNA levels. METHODS: In a representative subset of 201 of 266 randomized patients (104 in the dual-therapy arm and 97 in the triple-therapy arm) total HIV-1 DNA levels in whole blood at baseline and after 48 weeks and factors associated with the HIV-1 DNA levels were evaluated. RESULTS: The mean baseline HIV-1 DNA levels (2.47 log 10 copies/10 6 leucocytes) were comparable between arms. A significant mean decrease between baseline and week 48 was observed: -0.069 log 10 copies/10 6 leucocytes in the dual-therapy arm ( P  =   0.046) and -0.078 in the triple-therapy arm ( P  =   0.011); the mean difference between arms was -0.009 ( P  =   0.842). Nadir CD4 count was inversely correlated with baseline HIV-1 DNA ( P  =   0.009); longer duration of ART and lower nadir CD4 correlated with a less prominent HIV-1 DNA decrease (both P  <   0.005). Higher baseline HIV-1 DNA was associated with residual viraemia at week 48 ( P  =   0.031). CONCLUSIONS: When compared with continuing three-drug therapy, atazanavir/ritonavir+lamivudine dual therapy resulted in a similar decline in HIV-1 DNA levels in patients with sustained virological suppression. These data support the safety of this simplified treatment strategy in terms of its effect on the cellular HIV-1 reservoir
Inglese
Lombardi, F., Belmonti, S., Quiros Roldan, E., Latini, A., Castagna, A., D'ettorre, G., Gagliardini, R., Fabbiani, M., Cauda, R., De Luca, A., Di Giambenedetto, S., Evolution of blood-associated HIV-1 DNA levels after 48 weeks of switching to atazanavir/ritonavir+lamivudine dual therapy versus continuing triple therapy in the randomized AtLaS-M trial, <<JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY>>, 2017; (n/a): N/A-N/A. [doi:10.1093/jac/dkx068] [http://hdl.handle.net/10807/102550]
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/10807/102550
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