Objectives: Primary study outcome was absence of treatment failure (virological failure, VF, or treatment interruption) per protocol at week 48. Methods: Patients on 3-drug ART with stable HIV-1 RNA <50 copies/mL and CCR5-tropic virus were randomized 1:1 to maraviroc with darunavir/ritonavir qd (study arm) or continue current ART (continuation arm). Results: In June 2015, 115 patients were evaluable for the primary outcome (56 study, 59 continuation arm). The study was discontinued due to excess of VF in the study arm (7 cases, 12.5%, vs 0 in the continuation arm, p = 0.005). The proportion free of treatment failure was 73.2% in the study and 59.3% in the continuation arm. Two participants in the study and 10 in the continuation arm discontinued therapy due to adverse events (p = 0.030). At VF, no emergent drug resistance was detected. Co-receptor tropism switched to non-R5 in one patient. Patients with VF reported lower adherence and had lower plasma drug levels. Femoral bone mineral density was significantly improved in the study arm. Conclusion: Switching to maraviroc with darunavir/ritonavir qd in virologically suppressed patients was associated with improved tolerability but was virologically inferior to 3-drug therapy.
Switch to maraviroc with darunavir/r, both QD, in patients with suppressed HIV-1 was well tolerated but virologically inferior to standard antiretroviral therapy : 48-Week results of a randomized trial / B. Rossetti, R. Gagliardini, G. Meini, G. Sterrantino, V. Colangeli, R. Maria Carla, A. Latini, M. Colafigli, F. Vignale, S. Rusconi, V. Micheli, A.D. Biagio, G. Orofino, V. Ghisetti, A. Fantauzzi, V. Vullo, P. Grima, D. Francisci, C. Mastroianni, A. Antinori, M. Trezzi, L. Lisi, P. Navarra, B. Canovari, A. D'Arminio Monforte, S. Lamonica, A. D'Avino, M. Zazzi, S.D. Giambenedetto, A. De Luca. - In: PLOS ONE. - ISSN 1932-6203. - 12:11(2017 Nov 21), pp. e0187393.1-e0187393.18.
|Titolo:||Switch to maraviroc with darunavir/r, both QD, in patients with suppressed HIV-1 was well tolerated but virologically inferior to standard antiretroviral therapy : 48-Week results of a randomized trial|
|Parole Chiave:||Biochemistry, Genetics and Molecular Biology (all); Agricultural and Biological Sciences (all)|
|Settore Scientifico Disciplinare:||Settore MED/17 - Malattie Infettive|
|Data di pubblicazione:||21-nov-2017|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1371/journal.pone.0187393|
|Appare nelle tipologie:||01 - Articolo su periodico|