TY - JOUR
T1 - 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
AU - Rossetti, Barbara
AU - Gagliardini, Roberta
AU - Meini, Genny
AU - Sterrantino, Gaetana
AU - Colangeli, Vincenzo
AU - Re, Maria Carla
AU - Latini, Alessandra
AU - Colafigli, Manuela
AU - Vignale, Francesca
AU - Rusconi, Stefano
AU - Micheli, Valeria
AU - Biagio, Antonio Di
AU - Orofino, Giancarlo
AU - Ghisetti, Valeria
AU - Fantauzzi, Alessandra
AU - Vullo, Vincenzo
AU - Grima, Pierfrancesco
AU - Francisci, Daniela
AU - Mastroianni, Claudio
AU - Antinori, Andrea
AU - Trezzi, Michele
AU - Lisi, Lucia
AU - Navarra, Pierluigi
AU - Canovari, Benedetta
AU - D’Arminio Monforte, Antonella
AU - Lamonica, Silvia
AU - D'Avino, Alessandro
AU - Zazzi, Maurizio
AU - Di Giambenedetto, Simona
AU - De Luca, Andrea
PY - 2017
Y1 - 2017
N2 - 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.
AB - 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.
KW - Adult
KW - Agricultural and Biological Sciences (all)
KW - Anti-HIV Agents
KW - Antiretroviral Therapy, Highly Active
KW - Biochemistry, Genetics and Molecular Biology (all)
KW - Cyclohexanes
KW - Darunavir
KW - Drug Therapy, Combination
KW - Female
KW - HIV Infections
KW - HIV-1
KW - Humans
KW - Male
KW - Middle Aged
KW - Ritonavir
KW - Treatment Outcome
KW - Triazoles
KW - Viral Load
KW - Adult
KW - Agricultural and Biological Sciences (all)
KW - Anti-HIV Agents
KW - Antiretroviral Therapy, Highly Active
KW - Biochemistry, Genetics and Molecular Biology (all)
KW - Cyclohexanes
KW - Darunavir
KW - Drug Therapy, Combination
KW - Female
KW - HIV Infections
KW - HIV-1
KW - Humans
KW - Male
KW - Middle Aged
KW - Ritonavir
KW - Treatment Outcome
KW - Triazoles
KW - Viral Load
UR - http://hdl.handle.net/10807/112984
UR - http://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0187393&type=printable
U2 - 10.1371/journal.pone.0187393
DO - 10.1371/journal.pone.0187393
M3 - Article
SN - 1932-6203
VL - 12
SP - e0187393-N/A
JO - PLoS One
JF - PLoS One
ER -