Treatment simplification to atazanavir/ritonavir+lamivudine versus maintenance of atazanavir/ritonavir+two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M)
- Creators
- Di Giambenedetto, S.
- Fabbiani, M.
- Quiros Roldan, E.
- Latini, A.
- D'Ettorre, G.
- Antinori, A.
- Castagna, A.
- Orofino, G.
- Francisci, D.
- Chinello, P.
- Madeddu, G.
- Grima, P.
- Rusconi, S.
- Di Pietro, M.
- Mondi, A.
- Ciccarelli, N.
- Borghetti, A.
- Focà, E.
- Colafigli, M.
- De Luca, A.
- Cauda, R.
- Baldonero, E.
- Belmonti, S.
- D'Avino, A.
- Gagliardini, R.
- Lamonica, S.
- Lombardi, F.
- Sidella, L.
- Tamburrini, E.
- Visconti, E.
- Giacometti, A.
- Barchiesi, F.
- Castelli, P.
- Cirioni, O.
- Mazzocato, S.
- Blanc, P.
- Degli Esposti, A.
- Del Pin, B.
- Mariabelli, E.
- Marini, S.
- Poggi, A.
- 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.
- Zoppè, 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:
- Di Giambenedetto, S.
- Fabbiani, M.
- Quiros Roldan, E.
- Latini, A.
- D'Ettorre, G.
- Antinori, A.
- Castagna, A.
- Orofino, G.
- Francisci, D.
- Chinello, P.
- Madeddu, G.
- Grima, P.
- Rusconi, S.
- Di Pietro, M.
- Mondi, A.
- Ciccarelli, N.
- Borghetti, A.
- Focà, E.
- Colafigli, M.
- De Luca, A.
- Cauda, R.
- Baldonero, E.
- Belmonti, S.
- D'Avino, A.
- Gagliardini, R.
- Lamonica, S.
- Lombardi, F.
- Sidella, L.
- Tamburrini, E.
- Visconti, E.
- Giacometti, A.
- Barchiesi, F.
- Castelli, P.
- Cirioni, O.
- Mazzocato, S.
- Blanc, P.
- Degli Esposti, A.
- Del Pin, B.
- Mariabelli, E.
- Marini, S.
- Poggi, A.
- 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.
- Zoppè, 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
Background: Combination ART (cART)-related toxicities and costs have prompted the need for treatment simplification. The ATLAS-M trial explored 48 week non-inferior efficacy of simplification to atazanavir/ritonavir + lamivudine versus maintaining three-drug atazanavir/ritonavir-based cART in virologically suppressed patients. Methods: We performed an open-label, multicentre, randomized, non-inferiority study, enrolling HIV-infected adults on atazanavir/ritonavir+two NRTIs, with stable HIV-RNA <50 copies/mL and CD4+>200 cells/mm3. Main exclusion criteria were hepatitis B virus coinfection, past virological failure on or resistance to study drugs, recent AIDS and pregnancy. Patients were randomly assigned 1:1 to either switch to 300mg of atazanavir/ 100mg of ritonavir once daily and 300mg of lamivudine once daily (atazanavir/ritonavir+lamivudine arm) or to continue the previous regimen (atazanavir/ritonavir+two NRTIs arm). The primary study outcome was the maintenance of HIV-RNA <50 copies/mL at week 48 of the ITT-exposed (ITT-e) analysis with switch"failure. The non-inferiority margin was 12%. This study is registered at ClinicalTrials.gov, number NCT01599364. Results: Between July 2011 and June 2014, 266 patients were randomized (133 to each arm). After 48 weeks, the primary study outcome was met by 119 of 133 patients (89.5%) in the atazanavir/ritonavir+lamivudine arm and 106 of 133 patients (79.7%) in the atazanavir/ritonavir+two NRTIs arm [difference atazanavir/ritonavir+ lamivudine versus atazanavir/ritonavir+two NRTIs arm: +9.8% (95% CI+1.2 to+18.4)], demonstrating non-inferiority and superior efficacy of the atazanavir/ritonavir+lamivudine arm. Virological failure occurred in two (1.5%) patients in the atazanavir/ritonavir+lamivudine arm and six (4.5%) patients in the atazanavir/ritonavir+ two NRTIs arm, without resistance selection. A similar proportion of adverse events occurred in both arms. Conclusions: Treatment simplification to atazanavir/ritonavir+lamivudine showed non-inferior efficacy (superiority on post-hoc analysis) and a comparable safety profile over continuing atazanavir/ritonavir+two NRTIs in virologically suppressed patients.
Additional details
- URL
- http://hdl.handle.net/11567/893325
- URN
- urn:oai:iris.unige.it:11567/893325
- Origin repository
- UNIGE