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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 log10copies/106leucocytes) were comparable between arms. A significant mean decrease between baseline and week 48 was observed: -0.069 log10copies/106leucocytes 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.

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; Belmonti, Simone; Quiros-Roldan, Eugenia; Latini, Alessandra; Castagna, Antonella; D'Ettorre, Gabriella; Gagliardini, Roberta; Fabbiani, Massimiliano; Cauda, Roberto; De Luca, Andrea; Di Giambenedetto, Simona; Giacometti, Andrea; Di Pietro, Massimo; Mughini, Maria Teresa; Grima, Pierfrancesco; Viscoli, Claudio; Manconi, Paolo Emilio; Puoti, Massimo; Galli, Massimo; Viale, Pierluigi; Gori, Andrea; Rizzardini, Giuliano; Mineo, Maurizio; Antinori, Andrea; Petrosillo, Nicola; Vullo, Vincenzo; Mura, Maria Stella; Caramello, Pietro; Scotton, Pier Giorgio; Concia, Ercole; Lazzarin, Adriano; Francisci, Daniela; Sacchini, Daria. - In: JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY. - ISSN 0305-7453. - ELETTRONICO. - 72(2017), pp. 2055-2059.

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