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.
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Rossetti Barbara, Gagliardini Roberta, Meini Genny, Sterrantino Gaetana, Colangeli Vincenzo, Re Maria Carla, Latini Alessandra, Colafigli Manuela, Vignale Francesca, Rusconi Stefano, Micheli Valeria, Di Biagio Antonio, Orofino Giancarlo, Ghisetti Valeria, Fantauzzi Alessandra, Vullo Vincenzo, Grima Pierfrancesco, Francisci Daniela, Mastroianni Claudio, Antinori Andrea, Trezzi Michele, Lisi Lucia, Navarra Pierluigi, Canovari Benedetta, D'Arminio Monforte Antonella, Lamonica Silvia, D'Avino Alessandro, Zazzi Maurizio, Di Giambenedetto Simona, De Luca Andrea, for GUSTA trial study group
Аннотация
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.