Pett, Sarah Lilian, Amin, Janaki ORCID: 0000-0003-2161-9366, Horban, Andrejz, Andrade-Villanueva, Jaime, Losso, Marcelo, Porteiro, Norma, Sierra Madero, Juan, Belloso, Waldo, Tu, Elise, Silk, David, Kelleher, Anthony ORCID: 0000-0002-0009-3337, Harrigan, Richard, Clark, Andrew, Sugiura, Wataru, Wolff, Marcelo ORCID: 0000-0002-9956-8872, Gill, John, Gatell, Jose, Fisher, Martin, Clarke, Amanda, Ruxrungtham, Kiat, Prazuck, Thierry, Kaiser, Rolf, Woolley, Ian, Alberto Arnaiz, Juan, Cooper, David, Rockstroh, Jurgen K., Mallon, Patrick and Emery, Sean ORCID: 0000-0001-6072-8309 (2016). 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. Clin. Infect. Dis., 63 (1). S. 122 - 133. CARY: OXFORD UNIV PRESS INC. ISSN 1537-6591

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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. 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) <200copies/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. 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. 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Pett, Sarah LilianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Amin, JanakiUNSPECIFIEDorcid.org/0000-0003-2161-9366UNSPECIFIED
Horban, AndrejzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Andrade-Villanueva, JaimeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Losso, MarceloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Porteiro, NormaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sierra Madero, JuanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Belloso, WaldoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tu, EliseUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Silk, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kelleher, AnthonyUNSPECIFIEDorcid.org/0000-0002-0009-3337UNSPECIFIED
Harrigan, RichardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Clark, AndrewUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sugiura, WataruUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wolff, MarceloUNSPECIFIEDorcid.org/0000-0002-9956-8872UNSPECIFIED
Gill, JohnUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gatell, JoseUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fisher, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Clarke, AmandaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ruxrungtham, KiatUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Prazuck, ThierryUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaiser, RolfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Woolley, IanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alberto Arnaiz, JuanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cooper, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rockstroh, Jurgen K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mallon, PatrickUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Emery, SeanUNSPECIFIEDorcid.org/0000-0001-6072-8309UNSPECIFIED
URN: urn:nbn:de:hbz:38-271344
DOI: 10.1093/cid/ciw207
Journal or Publication Title: Clin. Infect. Dis.
Volume: 63
Number: 1
Page Range: S. 122 - 133
Date: 2016
Publisher: OXFORD UNIV PRESS INC
Place of Publication: CARY
ISSN: 1537-6591
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
INFECTED PATIENTS; ANTIRETROVIRAL THERAPY; VIROLOGICAL SUPPRESSION; CLINICAL-TRIALS; PROVIRAL DNA; TROPISM; RALTEGRAVIR; COMBINATION; EFFICACY; SAFETYMultiple languages
Immunology; Infectious Diseases; MicrobiologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/27134

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