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Maraviroc, as a Switch Option, in HIV-1-infected Individuals With Stable, Well-controlled HIV Replication and R5-tropic Virus on Their First Nucleoside/Nucleotide Reverse Transcriptase Inhibitor Plus Ritonavir-boosted Protease Inhibitor Regimen: Week 48 Results of the Randomized, Multicenter MARCH Study.

Authors :
Pett SL
Amin J
Horban A
Andrade-Villanueva J
Losso M
Porteiro N
Sierra Madero J
Belloso W
Tu E
Silk D
Kelleher A
Harrigan R
Clark A
Sugiura W
Wolff M
Gill J
Gatell J
Fisher M
Clarke A
Ruxrungtham K
Prazuck T
Kaiser R
Woolley I
Arnaiz JA
Cooper D
Rockstroh JK
Mallon P
Emery S
Source :
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2016 Jul 01; Vol. 63 (1), pp. 122-32. Date of Electronic Publication: 2016 Apr 05.
Publication Year :
2016

Abstract

Background: Alternative combination antiretroviral therapies in virologically suppressed human immunodeficiency virus (HIV)-infected patients experiencing side effects and/or at ongoing risk of important comorbidities from current therapy are needed. Maraviroc (MVC), a chemokine receptor 5 antagonist, is a potential alternative component of therapy in those with R5-tropic virus.<br />Methods: The Maraviroc Switch Study is a randomized, multicenter, 96-week, open-label switch study in HIV type 1-infected adults with R5-tropic virus, virologically suppressed on a ritonavir-boosted protease inhibitor (PI/r) plus double nucleoside/nucleotide reverse transcriptase inhibitor (2 N(t)RTI) backbone. Participants were randomized 1:2:2 to current combination antiretroviral therapy (control), or replacing the protease inhibitor (MVC + 2 N(t)RTI arm) or the nucleoside reverse transcriptase inhibitor backbone (MVC + PI/r arm) with twice-daily MVC. The primary endpoint was the difference (switch minus control) in proportion with plasma viral load (VL) <200 copies/mL at 48 weeks. The switch arms were judged noninferior if the lower limit of the 95% confidence interval (CI) for the difference in the primary endpoint was < -12% in the intention-to-treat (ITT) population.<br />Results: The ITT population comprised 395 participants (control, n = 82; MVC + 2 N(t)RTI, n = 156; MVC + PI/r, n = 157). Baseline characteristics were well matched. At week 48, noninferior rates of virological suppression were observed in those switching away from a PI/r (93.6% [95% CI, -9.0% to 2.2%] and 91.7% [95% CI, -9.6% to 3.8%] with VL <200 and <50 copies/mL, respectively) compared to the control arm (97.6% and 95.1% with VL <200 and <50 copies/mL, respectively). In contrast, MVC + PI/r did not meet noninferiority bounds and was significantly inferior (84.1% [95% CI, -19.8% to -5.8%] and 77.7% [95% CI, -24.9% to -8.4%] with VL <200 and <50 copies/mL, respectively) to the control arm in the ITT analysis.<br />Conclusions: These data support MVC as a switch option for ritonavir-boosted PIs when partnered with a 2-N(t)RTI backbone, but not as part of N(t)RTI-sparing regimens comprising MVC with PI/r.<br />Clinical Trials Registration: NCT01384682.<br /> (© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.)

Details

Language :
English
ISSN :
1537-6591
Volume :
63
Issue :
1
Database :
MEDLINE
Journal :
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Publication Type :
Academic Journal
Accession number :
27048747
Full Text :
https://doi.org/10.1093/cid/ciw207