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

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

Research output: Contribution to journalArticle

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 languageEnglish
Article numbere0187393
JournalPLoS One
Volume12
Issue number11
DOIs
Publication statusPublished - Nov 1 2017

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Human immunodeficiency virus 1
HIV-1
Ritonavir
Switches
therapeutics
Pharmaceutical Preparations
Drug therapy
Tropics
Treatment Failure
Viruses
Minerals
Outcome Assessment (Health Care)
Bone
Therapeutics
drugs
tropisms
Tropism
RNA
bone density
Plasmas

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 journalArticle

Rossetti, B, Gagliardini, R, Meini, G, Sterrantino, G, Colangeli, V, Re, MC, Latini, A, Colafigli, M, Vignale, F, Rusconi, S, Micheli, V, Biagio, AD, Orofino, G, Ghisetti, V, Fantauzzi, A, Vullo, V, Grima, P, Francisci, D, Mastroianni, C, Antinori, A, Trezzi, M, Lisi, L, Navarra, P, Canovari, B, D’Arminio Monforte, A, Lamonica, S, D’Avino, A, Zazzi, M, Giambenedetto, SD, De Luca, A & GUSTA trial study group 2017, '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', PLoS One, vol. 12, no. 11, e0187393. https://doi.org/10.1371/journal.pone.0187393
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. / 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. In: PLoS One. 2017 ; Vol. 12, No. 11.
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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.",
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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.

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