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

Nicoletta Ciccarelli; Roberto Cauda; Simona Di Giambenedetto; Massimiliano Fabbiani; Roberta Gagliardini; Pierfrancesco Grima; Francesca Lombardi; Alessandro D'Avino; Andrea De Luca; Eugenia Quiros Roldan; Alessandra Latini; Gabriella D'Ettorre; Antonella Castagna; Giancarlo Orofino; Daniela Francisci; Pierangelo Chinello; Giordano Madeddu; Stefano Rusconi; Barbara Del Pin; Emanuele Focà; E. Baldonero; L. Sidella; A. Giacometti; F. Barchiesi; P. Castelli; O. Cirioni; S. Mazzocato; M. Di Pietro; P. Blanc; A. Degli Esposti; E. Mariabelli; S. Marini; A. Poggi; E. Quiros Roldan; S. Amadasi; A. Apostoli; L. Biasi; A. Bonito; N. Brianese; S. Compostella; A. Ferraresi; D. Motta; M. T. Mughini; B. M. Celesia; M. Gussio; S. Sofia; M. Tana; P. Tundo; C. Viscoli; L. De Hoffer; A. Di Biagio; S. Grignolo; A. Parisini; E. Schenone; L. Taramasso; P. E. Manconi; A. Boccone; F. Ortu; P. Piano; L. Serusi; M. Puoti; M. C. Moioli; R. Rossotti; G. Travi; F. Ventura; M. Galli; S. Di Nardo Stuppino; V. Di Cristo; A. Giacomelli; V. Vimercati; P. Viale; A. Gori; G. Rizzardini; A. Capetti; L. Carenzi; F. Mazza; P. Meraviglia; S. Rosa; P. Zucchi; M. Mineo; M. Giuliani; A. Pacifici; F. Pimpinelli; F. Stivali; F. Angelici; R. Bellagamba; D. Delle Rose; R. Fezza; R. Libertone; S. Mosti; P. Narciso; E. Nicastri; S. Ottou; C. Tomassi; C. Vlassi; M. Zaccarelli; F. Zoppè; V. Vullo; F. Altavilla; G. Ceccarelli; A. Fantauzzi; S. Gebremeskel; S. Lo Menzo; I. Mezzaroma; F. Tierno; N. Petrosillo; E. Boumis; S. Cicalini; E. Grilli; M. Musso; C. Stella; M. S. Mura; P. Bagella; M. Mannazzu; V. Soddu; P. Caramello; C. Carcieri; S. Carosella; M. Farenga; P. G. Scotton; M. C. Rossi; E. Concia; F. Corsini; C. Gricolo; M. Lanzafame; E. Lattuada; S. Leonardi; F. Rigo; A. Lazzarin; A. Bigoloni; E. Carini; S. Nozza; V. Spagnuolo; B. Belfiori; L. Malincarne; E. Schiaroli; C. Sfara; A. Tosti; D. Sacchini; A. Ruggieri; C. Valdatta

doi:10.1093/jac/dky123

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

Nicoletta Ciccarelli, Roberto Cauda, Simona Di Giambenedetto, Massimiliano Fabbiani, Roberta Gagliardini, Pierfrancesco Grima, Francesca Lombardi, Alessandro D'Avino, Andrea De Luca, Eugenia Quiros Roldan, Alessandra Latini, Gabriella D'Ettorre, Antonella Castagna, Giancarlo Orofino, Daniela Francisci, Pierangelo Chinello, Giordano Madeddu, Stefano Rusconi, Barbara Del Pin, Emanuele FocàE. Baldonero, L. Sidella, A. Giacometti, F. Barchiesi, P. Castelli, O. Cirioni, S. Mazzocato, M. Di Pietro, P. Blanc, A. Degli Esposti, E. Mariabelli, S. Marini, A. Poggi, E. Quiros Roldan, S. Amadasi, A. Apostoli, L. Biasi, A. Bonito, N. Brianese, S. Compostella, A. Ferraresi, D. Motta, M. T. Mughini, B. M. Celesia, M. Gussio, S. Sofia, M. Tana, P. Tundo, C. Viscoli, L. De Hoffer, A. Di Biagio, S. Grignolo, A. Parisini, E. Schenone, L. Taramasso, P. E. Manconi, A. Boccone, F. Ortu, P. Piano, L. Serusi, M. Puoti, M. C. Moioli, R. Rossotti, G. Travi, F. Ventura, M. Galli, S. Di Nardo Stuppino, V. Di Cristo, A. Giacomelli, V. Vimercati, P. Viale, A. Gori, G. Rizzardini, A. Capetti, L. Carenzi, F. Mazza, P. Meraviglia, S. Rosa, P. Zucchi, M. Mineo, M. Giuliani, A. Pacifici, F. Pimpinelli, F. Stivali, F. Angelici, R. Bellagamba, D. Delle Rose, R. Fezza, R. Libertone, S. Mosti, P. Narciso, E. Nicastri, S. Ottou, C. Tomassi, C. Vlassi, M. Zaccarelli, F. Zoppè, V. Vullo, F. Altavilla, G. Ceccarelli, A. Fantauzzi, S. Gebremeskel, S. Lo Menzo, I. Mezzaroma, F. Tierno, N. Petrosillo, E. Boumis, S. Cicalini, E. Grilli, M. Musso, C. Stella, M. S. Mura, P. Bagella, M. Mannazzu, V. Soddu, P. Caramello, C. Carcieri, S. Carosella, M. Farenga, P. G. Scotton, M. C. Rossi, E. Concia, F. Corsini, C. Gricolo, M. Lanzafame, E. Lattuada, S. Leonardi, F. Rigo, A. Lazzarin, A. Bigoloni, E. Carini, S. Nozza, V. Spagnuolo, B. Belfiori, L. Malincarne, E. Schiaroli, C. Sfara, A. Tosti, D. Sacchini, A. Ruggieri, C. Valdatta

Risultato della ricerca: Contributo in rivista › Articolo in rivista

17 Citazioni (Scopus)

Abstract

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/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. 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.

Lingua originale	English
pagine (da-a)	1955-1964
Numero di pagine	10
Rivista	Journal of Antimicrobial Chemotherapy
Volume	73
DOI	https://doi.org/10.1093/jac/dky123
Stato di pubblicazione	Pubblicato - 2018

Keywords

HIV
TRIAL

Accesso al documento

10.1093/jac/dky123

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Ciccarelli, N., Cauda, R., Di Giambenedetto, S., Fabbiani, M., Gagliardini, R., Grima, P., Lombardi, F., D'Avino, A., De Luca, A., Roldan, E. Q., Latini, A., D'Ettorre, G., Castagna, A., Orofino, G., Francisci, D., Chinello, P., Madeddu, G., Rusconi, S., Del Pin, B., ... Valdatta, C. (2018). Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial. Journal of Antimicrobial Chemotherapy, 73, 1955-1964. https://doi.org/10.1093/jac/dky123

Ciccarelli, Nicoletta ; Cauda, Roberto ; Di Giambenedetto, Simona ; Fabbiani, Massimiliano ; Gagliardini, Roberta ; Grima, Pierfrancesco ; Lombardi, Francesca ; D'Avino, Alessandro ; De Luca, Andrea ; Roldan, Eugenia Quiros ; Latini, Alessandra ; D'Ettorre, Gabriella ; Castagna, Antonella ; Orofino, Giancarlo ; Francisci, Daniela ; Chinello, Pierangelo ; Madeddu, Giordano ; Rusconi, Stefano ; Del Pin, Barbara ; Focà, Emanuele ; Baldonero, E. ; Sidella, L. ; 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. ; 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. / Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial. In: Journal of Antimicrobial Chemotherapy. 2018 ; Vol. 73. pagg. 1955-1964.

@article{3ecb94b155f5414c83d4973f81258ef7,

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

abstract = "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/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. 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.",

keywords = "HIV, TRIAL, HIV, TRIAL",

author = "Nicoletta Ciccarelli and Roberto Cauda and {Di Giambenedetto}, Simona and Massimiliano Fabbiani and Roberta Gagliardini and Pierfrancesco Grima and Francesca Lombardi and Alessandro D'Avino and {De Luca}, Andrea and Roldan, {Eugenia Quiros} and Alessandra Latini and Gabriella D'Ettorre and Antonella Castagna and Giancarlo Orofino and Daniela Francisci and Pierangelo Chinello and Giordano Madeddu and Stefano Rusconi and {Del Pin}, Barbara and Emanuele Foc{\`a} and E. Baldonero and L. Sidella and A. Giacometti and F. Barchiesi and P. Castelli and O. Cirioni and S. Mazzocato and {Di Pietro}, M. and P. Blanc and {Degli Esposti}, A. and E. Mariabelli and S. Marini and A. Poggi and {Quiros Roldan}, E. and S. Amadasi and A. Apostoli and L. Biasi and A. Bonito and N. Brianese and S. Compostella and A. Ferraresi and D. Motta and Mughini, {M. T.} and Celesia, {B. M.} and M. Gussio and S. Sofia and M. Tana and P. Tundo and C. Viscoli and {De Hoffer}, L. and {Di Biagio}, A. and S. Grignolo and A. Parisini and E. Schenone and L. Taramasso and Manconi, {P. E.} and A. Boccone and F. Ortu and P. Piano and L. Serusi and M. Puoti and Moioli, {M. C.} and R. Rossotti and G. Travi and F. Ventura and M. Galli and {Di Nardo Stuppino}, S. and {Di Cristo}, V. and A. Giacomelli and V. Vimercati and P. Viale and A. Gori and G. Rizzardini and A. Capetti and L. Carenzi and F. Mazza and P. Meraviglia and S. Rosa and P. Zucchi and M. Mineo and M. Giuliani and A. Pacifici and F. Pimpinelli and F. Stivali and F. Angelici and R. Bellagamba and {Delle Rose}, D. and R. Fezza and R. Libertone and S. Mosti and P. Narciso and E. Nicastri and S. Ottou and C. Tomassi and C. Vlassi and M. Zaccarelli and F. Zopp{\`e} and V. Vullo and F. Altavilla and G. Ceccarelli and A. Fantauzzi and S. Gebremeskel and {Lo Menzo}, S. and I. Mezzaroma and F. Tierno and N. Petrosillo and E. Boumis and S. Cicalini and E. Grilli and M. Musso and C. Stella and Mura, {M. S.} and P. Bagella and M. Mannazzu and V. Soddu and P. Caramello and C. Carcieri and S. Carosella and M. Farenga and Scotton, {P. G.} and Rossi, {M. C.} and E. Concia and F. Corsini and C. Gricolo and M. Lanzafame and E. Lattuada and S. Leonardi and F. Rigo and A. Lazzarin and A. Bigoloni and E. Carini and S. Nozza and V. Spagnuolo and B. Belfiori and L. Malincarne and E. Schiaroli and C. Sfara and A. Tosti and D. Sacchini and A. Ruggieri and C. Valdatta",

year = "2018",

doi = "10.1093/jac/dky123",

language = "English",

volume = "73",

pages = "1955--1964",

journal = "Journal of Antimicrobial Chemotherapy",

issn = "0305-7453",

publisher = "Oxford University Press:Journals Department, Great Clarendon Street, Oxford OX2 6DP United Kingdom:011 44 1865 556767, EMAIL: jnlorders@oup.co.uk, INTERNET: http://www.oup.co.uk, Fax: 011 44 1865 267485",

}

Ciccarelli, N , Cauda, R , Di Giambenedetto, S, Fabbiani, M, Gagliardini, R, Grima, P, Lombardi, F, D'Avino, A, De Luca, A, Roldan, EQ, Latini, A, D'Ettorre, G, Castagna, A, Orofino, G, Francisci, D, Chinello, P, Madeddu, G, Rusconi, S, Del Pin, B, Focà, E, Baldonero, E, Sidella, L, 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, MT, Celesia, BM, 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, PE, Boccone, A, Ortu, F, Piano, P, Serusi, L, Puoti, M, Moioli, MC, 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, 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, MS, Bagella, P, Mannazzu, M, Soddu, V, Caramello, P, Carcieri, C, Carosella, S, Farenga, M, Scotton, PG, Rossi, MC, 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 2018, 'Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial', Journal of Antimicrobial Chemotherapy, vol. 73, pagg. 1955-1964. https://doi.org/10.1093/jac/dky123

Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial. / Ciccarelli, Nicoletta ; Cauda, Roberto ; Di Giambenedetto, Simona; Fabbiani, Massimiliano; Gagliardini, Roberta; Grima, Pierfrancesco; Lombardi, Francesca; D'Avino, Alessandro; De Luca, Andrea; Roldan, Eugenia Quiros; Latini, Alessandra; D'Ettorre, Gabriella; Castagna, Antonella; Orofino, Giancarlo; Francisci, Daniela; Chinello, Pierangelo; Madeddu, Giordano; Rusconi, Stefano; Del Pin, Barbara; Focà, Emanuele; Baldonero, E.; Sidella, L.; 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.; 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.

In: Journal of Antimicrobial Chemotherapy, Vol. 73, 2018, pag. 1955-1964.

Risultato della ricerca: Contributo in rivista › Articolo in rivista

TY - JOUR

T1 - Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial

AU - Ciccarelli, Nicoletta

AU - Cauda, Roberto

AU - Di Giambenedetto, Simona

AU - Fabbiani, Massimiliano

AU - Gagliardini, Roberta

AU - Grima, Pierfrancesco

AU - Lombardi, Francesca

AU - D'Avino, Alessandro

AU - De Luca, Andrea

AU - Roldan, Eugenia Quiros

AU - Latini, Alessandra

AU - D'Ettorre, Gabriella

AU - Castagna, Antonella

AU - Orofino, Giancarlo

AU - Francisci, Daniela

AU - Chinello, Pierangelo

AU - Madeddu, Giordano

AU - Rusconi, Stefano

AU - Del Pin, Barbara

AU - Focà, Emanuele

AU - Baldonero, E.

AU - Sidella, L.

AU - Giacometti, A.

AU - Barchiesi, F.

AU - Castelli, P.

AU - Cirioni, O.

AU - Mazzocato, S.

AU - Di Pietro, M.

AU - Blanc, P.

AU - Degli Esposti, A.

AU - Mariabelli, E.

AU - Marini, S.

AU - Poggi, A.

AU - Quiros Roldan, E.

AU - Amadasi, S.

AU - Apostoli, A.

AU - Biasi, L.

AU - Bonito, A.

AU - Brianese, N.

AU - Compostella, S.

AU - Ferraresi, A.

AU - Motta, D.

AU - Mughini, M. T.

AU - Celesia, B. M.

AU - Gussio, M.

AU - Sofia, S.

AU - Tana, M.

AU - Tundo, P.

AU - Viscoli, C.

AU - De Hoffer, L.

AU - Di Biagio, A.

AU - Grignolo, S.

AU - Parisini, A.

AU - Schenone, E.

AU - Taramasso, L.

AU - Manconi, P. E.

AU - Boccone, A.

AU - Ortu, F.

AU - Piano, P.

AU - Serusi, L.

AU - Puoti, M.

AU - Moioli, M. C.

AU - Rossotti, R.

AU - Travi, G.

AU - Ventura, F.

AU - Galli, M.

AU - Di Nardo Stuppino, S.

AU - Di Cristo, V.

AU - Giacomelli, A.

AU - Vimercati, V.

AU - Viale, P.

AU - Gori, A.

AU - Rizzardini, G.

AU - Capetti, A.

AU - Carenzi, L.

AU - Mazza, F.

AU - Meraviglia, P.

AU - Rosa, S.

AU - Zucchi, P.

AU - Mineo, M.

AU - Giuliani, M.

AU - Pacifici, A.

AU - Pimpinelli, F.

AU - Stivali, F.

AU - Angelici, F.

AU - Bellagamba, R.

AU - Delle Rose, D.

AU - Fezza, R.

AU - Libertone, R.

AU - Mosti, S.

AU - Narciso, P.

AU - Nicastri, E.

AU - Ottou, S.

AU - Tomassi, C.

AU - Vlassi, C.

AU - Zaccarelli, M.

AU - Zoppè, F.

AU - Vullo, V.

AU - Altavilla, F.

AU - Ceccarelli, G.

AU - Fantauzzi, A.

AU - Gebremeskel, S.

AU - Lo Menzo, S.

AU - Mezzaroma, I.

AU - Tierno, F.

AU - Petrosillo, N.

AU - Boumis, E.

AU - Cicalini, S.

AU - Grilli, E.

AU - Musso, M.

AU - Stella, C.

AU - Mura, M. S.

AU - Bagella, P.

AU - Mannazzu, M.

AU - Soddu, V.

AU - Caramello, P.

AU - Carcieri, C.

AU - Carosella, S.

AU - Farenga, M.

AU - Scotton, P. G.

AU - Rossi, M. C.

AU - Concia, E.

AU - Corsini, F.

AU - Gricolo, C.

AU - Lanzafame, M.

AU - Lattuada, E.

AU - Leonardi, S.

AU - Rigo, F.

AU - Lazzarin, A.

AU - Bigoloni, A.

AU - Carini, E.

AU - Nozza, S.

AU - Spagnuolo, V.

AU - Belfiori, B.

AU - Malincarne, L.

AU - Schiaroli, E.

AU - Sfara, C.

AU - Tosti, A.

AU - Sacchini, D.

AU - Ruggieri, A.

AU - Valdatta, C.

PY - 2018

Y1 - 2018

N2 - 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/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. 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.

AB - 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/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. 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.

KW - HIV

KW - TRIAL

KW - HIV

KW - TRIAL

UR - http://hdl.handle.net/10807/124520

U2 - 10.1093/jac/dky123

DO - 10.1093/jac/dky123

M3 - Article

VL - 73

SP - 1955

EP - 1964

JO - Journal of Antimicrobial Chemotherapy

JF - Journal of Antimicrobial Chemotherapy

SN - 0305-7453

ER -