Abstract
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.
| Original language | English |
|---|---|
| Article number | e0187393 |
| Journal | PLoS One |
| Volume | 12 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - Nov 1 2017 |
Fingerprint
ASJC Scopus subject areas
- Biochemistry, Genetics and Molecular Biology(all)
- Agricultural and Biological Sciences(all)
Cite this
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. / Rossetti, Barbara; Gagliardini, Roberta; Meini, Genny; Sterrantino, Gaetana; Colangeli, Vincenzo; Re, Maria Carla; Latini, Alessandra; Colafigli, Manuela; Vignale, Francesca; Rusconi, Stefano; Micheli, Valeria; Biagio, Antonio Di; 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; Giambenedetto, Simona Di; De Luca, Andrea; GUSTA trial study group.
In: PLoS One, Vol. 12, No. 11, e0187393, 01.11.2017.Research output: Contribution to journal › Article
}
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
T2 - 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 - Giambenedetto, Simona Di
AU - De Luca, Andrea
AU - GUSTA trial study group
PY - 2017/11/1
Y1 - 2017/11/1
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.
UR - http://www.scopus.com/inward/record.url?scp=85034748224&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85034748224&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0187393
DO - 10.1371/journal.pone.0187393
M3 - Article
C2 - 29161288
AN - SCOPUS:85034748224
VL - 12
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 11
M1 - e0187393
ER -