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Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial

2018; Oxford University Press; Volume: 73; Issue: 7 Linguagem: Inglês

10.1093/jac/dky123

1460-2091

Massimiliano Fabbiani, Roberta Gagliardini, Nicoletta Ciccarelli, Eugenia Quirós-Roldán, Alessandra Latini, Gabriella d’Ettorre, Andrea Antinori, Antonella Castagna, Giancarlo Orofino, Daniela Francisci, Pierangelo Chinello, Giordano Madeddu, Pierfrancesco Grima, Stefano Rusconi, B. Del Pin, Francesca Lombardi, A D’Avino, Emanuele Focà, Manuela Colafigli, Roberto Cauda, Simona Di Giambenedetto, Andrea De Luca, Roberto Cauda, Simona Di Giambenedetto, Massimiliano Fabbiani, Annalisa Mondi, Nicoletta Ciccarelli, Alberto Borghetti, Eleonora Baldonero, Simone Belmonti, A D’Avino, Roberta Gagliardini, Silvia Lamonica, Francesca Lombardi, Letizia Sidella, Enrica Tamburrini, Emiliano Visconti, Andrea De Luca, Maria Carla Re, Francesco Barchiesi, P. Castelli, Oscar Cirioni, Susanna Mazzocato, Massimo Di Pietro, Pierluigi Blanc, Anna Degli Esposti, B. Del Pin, Elisa Mariabelli, Sofia Helena Valente de Lemos‐Marini, Alessia Poggi, Eugenia Quirós-Roldán, Emanuele Focà, Silvia Amadasi, A. Apostoli, L. Biasi, Andrea Bonito, Nigritella Brianese, Silvia Compostella, A Ferraresi, Davide Motta, M. T. Mughini, Benedetto Maurizio Celesia, Maria Gussio, Silvia Sofia, Pierfrancesco Grima, M Tana, Paolo Tundo, Claudio Viscoli, L De Hoffer, Antonio Di Biagio, Sara Grignolo, Andrea Parisini, Emanuela Schenone, Lucia Taramasso, P E Manconi, A Boccone, Francesco Perna, P Piano, Loredana Serusi, Massimo Puoti, M C Moioli, Roberto Rossotti, Giovanna Travi, François Ventura, Massimo Galli, Stefano Rusconi, Silvia Di Nardo Stuppino, Valentina Di Cristo, Andrea Giacomelli, V Vimercati, Pierluigi Viale, Andrea Gori, Giuliano Rizzardini, Amedeo Capetti, Laura Carenzi, Francesca Mazza, Paola Meraviglia, Suélia de Siqueira Rodrigues Fleury Rosa, Paola Zucchi, M Mineo, Alessandra Latini, Manuela Colafigli, Massimo Giuliani, Andrea Pacifici, Fulvia Pimpinelli, F. M. Solivetti, Francesca Stivali, Andrea Antinori, F Angelici, Rita Bellagamba, D Delle Rose, Rita Fezza, Raffaella Libertone, Silvia Mosti, Pasquale Narciso, Emanuele Nicastri, Sandrine Ottou, C Tomassi, Chrysoula Vlassi, Mauro Zaccarelli, F Zoppè, Vincenzo Vullo, Gabriella d’Ettorre, F Altavilla, Giancarlo Ceccarelli, Alessandra Fantauzzi, Simon Gebremeskel, Stefano Menzo, Ivano Mezzaroma, Francesca Tierno, Nicola Petrosillo, Pierangelo Chinello, Evangelo Boumis, Stefania Cicalini, Elisabetta Grilli, Maria Musso, Carmelo Carlo‐Stella, M.S. Mura, Giordano Madeddu, P Bagella, M Mannazzu, V Soddu, P Caramello, Giancarlo Orofino, Chiara Carcieri, S Carosella, M Farenga, Piergiorgio Scotton, Maria Cecilia Rossi, Ercole Concia, F Corsini, C Gricolo, Massimiliano Lanzafame, E Lattuada, Sabina Leonardi, F Rigo, Adriano Lazzarin, Antonella Castagna, Alba Bigoloni, Elisa Carini, Silvia Nozza, Vincenzo Spagnuolo, Daniela Francisci, Barbara Belfiori, Lisa Malincarne, Elisabetta Schiaroli, C Sfara, Antonellá Tosti, D. Sacchini, Anna Ruggieri, Caterina Valdatta,

HIV/AIDS Research and Interventions

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. ATLAS-M is a 96 week open-label, randomized, non-inferiority (margin −12%) trial enrolling HIV-infected adults on atazanavir/ritonavir + 2NRTI, with stable HIV-RNA 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. 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 therapy (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, respectively, 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 hypertriglyceridaemia (6.8% versus 1.5%, P = 0.031) occurred with dual therapy, although this never led to treatment discontinuation. 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. 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 benefit in terms of improved renal function and bone mineral density.