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

Pett, Sarah Lilian, Amin, Janaki, Horban, Andrejz, Andrade-Villanueva, Jaime, Losso, Marcelo, Porteiro, Norma, Sierra Madero, Juan, Belloso, Waldo, Tu, Elise, Silk, David, Kelleher, Anthony, Harrigan, Richard, Clark, Andrew, Sugiura, Wataru, Wolff, Marcelo, 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 (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. Clinical Infectious Diseases, 63 1: 122-132. doi:10.1093/cid/ciw207


Author Pett, Sarah Lilian
Amin, Janaki
Horban, Andrejz
Andrade-Villanueva, Jaime
Losso, Marcelo
Porteiro, Norma
Sierra Madero, Juan
Belloso, Waldo
Tu, Elise
Silk, David
Kelleher, Anthony
Harrigan, Richard
Clark, Andrew
Sugiura, Wataru
Wolff, Marcelo
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
Emery, Sean
Title 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
Journal name Clinical Infectious Diseases   Check publisher's open access policy
ISSN 1537-6591
1058-4838
Publication date 2016-07-01
Year available 2016
Sub-type Article (original research)
DOI 10.1093/cid/ciw207
Open Access Status Not yet assessed
Volume 63
Issue 1
Start page 122
End page 132
Total pages 11
Place of publication Cary, NC, United States
Publisher Oxford University Press
Collection year 2017
Language eng
Formatted 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) <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.

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.

Clinical Trials Registration. NCT01384682.
Keyword Antiretroviral
Comorbidity.
HIV-1
Maraviroc
Switch
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: HERDC Pre-Audit
School of Medicine Publications
 
Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 1 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 1 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Created: Sat, 18 Mar 2017, 01:00:47 EST by Web Cron on behalf of Learning and Research Services (UQ Library)