Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial
- Creators
- Fabbiani M.
- Gagliardini R.
- Ciccarelli N.
- Roldan E. Q.
- Latini A.
- d'Ettorre G.
- Antinori A.
- Castagna A.
- Orofino G.
- Francisci D.
- Chinello P.
- Madeddu G.
- Grima P.
- Rusconi S.
- Del Pin B.
- Lombardi F.
- D'Avino A.
- Foca E.
- Colafigli M.
- Cauda R.
- Di Giambenedetto S.
- De Luca A.
- Mondi A.
- Borghetti A.
- Baldonero E.
- Belmonti S.
- Lamonica S.
- Sidella L.
- Tamburrini E.
- Visconti E.
- Giacometti A.
- Barchiesi F.
- Castelli P.
- Cirioni O.
- Mazzocato S.
- Di Pietro M.
- Blanc P.
- Degli Esposti A.
- Mariabelli E.
- Marini S.
- Poggi A.
- Quiros Roldan E.
- Amadasi S.
- Apostoli A.
- Biasi L.
- Bonito A.
- Brianese N.
- Compostella S.
- Ferraresi A.
- Motta D.
- Mughini M. T.
- Celesia B. M.
- Gussio M.
- Sofia S.
- Tana M.
- Tundo P.
- Viscoli C.
- De Hoffer L.
- Di Biagio A.
- Grignolo S.
- Parisini A.
- Schenone E.
- Taramasso L.
- Manconi P. E.
- Boccone A.
- Ortu F.
- Piano P.
- Serusi L.
- Puoti M.
- Moioli M. C.
- Rossotti R.
- Travi G.
- Ventura F.
- Galli M.
- Di Nardo Stuppino S.
- Di Cristo V.
- Giacomelli A.
- Vimercati V.
- Viale P.
- Gori A.
- Rizzardini G.
- Capetti A.
- Carenzi L.
- Mazza F.
- Meraviglia P.
- Rosa S.
- Zucchi P.
- Mineo M.
- Giuliani M.
- Pacifici A.
- Pimpinelli F.
- Solivetti F.
- Stivali F.
- Angelici F.
- Bellagamba R.
- Delle Rose D.
- Fezza R.
- Libertone R.
- Mosti S.
- Narciso P.
- Nicastri E.
- Ottou S.
- Tomassi C.
- Vlassi C.
- Zaccarelli M.
- Zoppe F.
- Vullo V.
- Altavilla F.
- Ceccarelli G.
- Fantauzzi A.
- Gebremeskel S.
- Lo Menzo S.
- Mezzaroma I.
- Tierno F.
- Petrosillo N.
- Boumis E.
- Cicalini S.
- Grilli E.
- Musso M.
- Stella C.
- Mura M. S.
- Bagella P.
- Mannazzu M.
- Soddu V.
- Caramello P.
- Carcieri C.
- Carosella S.
- Farenga M.
- Scotton P. G.
- Rossi M. C.
- Concia E.
- Corsini F.
- Gricolo C.
- Lanzafame M.
- Lattuada E.
- Leonardi S.
- Rigo F.
- Lazzarin A.
- Bigoloni A.
- Carini E.
- Nozza S.
- Spagnuolo V.
- Belfiori B.
- Malincarne L.
- Schiaroli E.
- Sfara C.
- Tosti A.
- Sacchini D.
- Ruggieri A.
- Valdatta C.
- Others:
- Fabbiani, M.
- Gagliardini, R.
- Ciccarelli, N.
- Roldan, E. Q.
- Latini, A.
- D'Ettorre, G.
- Antinori, A.
- Castagna, A.
- Orofino, G.
- Francisci, D.
- Chinello, P.
- Madeddu, G.
- Grima, P.
- Rusconi, S.
- Del Pin, B.
- Lombardi, F.
- D'Avino, A.
- Foca, E.
- Colafigli, M.
- Cauda, R.
- Di Giambenedetto, S.
- De Luca, A.
- Mondi, A.
- Borghetti, A.
- Baldonero, E.
- Belmonti, S.
- Lamonica, S.
- Sidella, L.
- Tamburrini, E.
- Visconti, E.
- Giacometti, A.
- Barchiesi, F.
- Castelli, P.
- Cirioni, O.
- Mazzocato, S.
- Di Pietro, M.
- Blanc, P.
- Degli Esposti, A.
- Mariabelli, E.
- Marini, S.
- Poggi, A.
- Quiros Roldan, E.
- Amadasi, S.
- Apostoli, A.
- Biasi, L.
- Bonito, A.
- Brianese, N.
- Compostella, S.
- Ferraresi, A.
- Motta, D.
- Mughini, M. T.
- Celesia, B. M.
- Gussio, M.
- Sofia, S.
- Tana, M.
- Tundo, P.
- Viscoli, C.
- De Hoffer, L.
- Di Biagio, A.
- Grignolo, S.
- Parisini, A.
- Schenone, E.
- Taramasso, L.
- Manconi, P. E.
- Boccone, A.
- Ortu, F.
- Piano, P.
- Serusi, L.
- Puoti, M.
- Moioli, M. C.
- Rossotti, R.
- Travi, G.
- Ventura, F.
- Galli, M.
- Di Nardo Stuppino, S.
- Di Cristo, V.
- Giacomelli, A.
- Vimercati, V.
- Viale, P.
- Gori, A.
- Rizzardini, G.
- Capetti, A.
- Carenzi, L.
- Mazza, F.
- Meraviglia, P.
- Rosa, S.
- Zucchi, P.
- Mineo, M.
- Giuliani, M.
- Pacifici, A.
- Pimpinelli, F.
- Solivetti, F.
- Stivali, F.
- Angelici, F.
- Bellagamba, R.
- Delle Rose, D.
- Fezza, R.
- Libertone, R.
- Mosti, S.
- Narciso, P.
- Nicastri, E.
- Ottou, S.
- Tomassi, C.
- Vlassi, C.
- Zaccarelli, M.
- Zoppe, F.
- Vullo, V.
- Altavilla, F.
- Ceccarelli, G.
- Fantauzzi, A.
- Gebremeskel, S.
- Lo Menzo, S.
- Mezzaroma, I.
- Tierno, F.
- Petrosillo, N.
- Boumis, E.
- Cicalini, S.
- Grilli, E.
- Musso, M.
- Stella, C.
- Mura, M. S.
- Bagella, P.
- Mannazzu, M.
- Soddu, V.
- Caramello, P.
- Carcieri, C.
- Carosella, S.
- Farenga, M.
- Scotton, P. G.
- Rossi, M. C.
- Concia, E.
- Corsini, F.
- Gricolo, C.
- Lanzafame, M.
- Lattuada, E.
- Leonardi, S.
- Rigo, F.
- Lazzarin, A.
- Bigoloni, A.
- Carini, E.
- Nozza, S.
- Spagnuolo, V.
- Belfiori, B.
- Malincarne, L.
- Schiaroli, E.
- Sfara, C.
- Tosti, A.
- Sacchini, D.
- Ruggieri, A.
- Valdatta, C.
Description
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 96 week open-label, randomized, non-inferiority (margin -12%) trial enrolling HIV-infected adults on atazanavir/ritonavir+2NRTI, with stable HIV-RNA < 50 copies/mL and CD4 counts.200 cells/mm 3 . 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 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. 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 benefit in terms of improved renal function and bone mineral density.
Additional details
- URL
- http://hdl.handle.net/11567/950257
- URN
- urn:oai:iris.unige.it:11567/950257
- Origin repository
- UNIGE