Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study

S. L. Pett, J. Amin, A. Horban, J. Andrade-Villanueva, M. Losso, N. Porteiro, J. S. Madero, W. Belloso, E. Tu, D. Silk, A. Kelleher, R. Harrigan, A. Clark, W. Sugiura, M. Wolff, J. Gill, J. Gatell, A. Clarke, K. Ruxrungtham, T. Prazuck & 8 others R. Kaiser, I. Woolley, J. Alberto Arnaiz, D. Cooper, J. K. Rockstroh, P. Mallon, S. Emery, MARCH Study Group

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objectives: The Maraviroc Switch (MARCH) study week 48 data demonstrated that maraviroc, a chemokine receptor-5 (CCR5) inhibitor, was a safe and effective switch for the ritonavir-boosted protease inhibitor (PI/r) component of a two nucleos(t)ide reverse transcriptase inhibitor [N(t)RTI] plus PI/r-based antiretroviral regimen in patients with R5-tropic virus. Here we report the durability of this finding. Methods: MARCH, an international, multicentre, randomized, 96-week open-label switch study, enrolled HIV-1-infected adults with R5-tropic virus who were stable (> 24 weeks) and virologically suppressed [plasma viral load (pVL) < 50 HIV-1 RNA copies/mL]. Participants were randomized to continue their current PI/r-based regimen (PI/r) or to switch to MVC plus two N(t)RTIs (MVC) (1:2 randomization). The primary endpoint was the difference in the proportion with pVL < 200 copies/mL at 96 weeks. The switch arm was defined as noninferior if the lower limit of the 95% confidence interval (CI) for the difference was < -12% in the intention-to-treat (ITT) population. Safety endpoints (the difference in the mean change from baseline or a comparison of proportions) were analysed as key secondary endpoints. Results: Eighty-two (PI/r) and 156 (MVC) participants were randomized and included in the ITT analysis; 71 (87%) and 130 (83%) were in follow-up and on therapy at week 96. At week 96, 89.0% and 90.4% in the PI/r and MVC arms, respectively, had pVL < 50 copies/mL (95% CI -6.6, 10.2). Moreover, in those switching away from PI/r, there were significant reductions in mean total cholesterol (differences 0.31 mmol/L; P = 0.02) and triglycerides (difference 0.44 mmol/L; P < 0.001). Changes in CD4 T-cell count, renal function, and serious and nonserious adverse events were similar in the two arms. Conclusions: MVC as a switch for a PI/r is safe and effective at maintaining virological suppression while having significant lipid benefits over 96 weeks.

Original languageEnglish
Pages (from-to)65-71
Number of pages7
JournalHIV Medicine
Volume19
Issue number1
Early online date2017
DOIs
Publication statusPublished - Jan 2018
Externally publishedYes

Keywords

  • HIV-1
  • maraviroc
  • protease inhibitor
  • switch

Fingerprint Dive into the research topics of 'Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study'. Together they form a unique fingerprint.

  • Cite this

    Pett, S. L., Amin, J., Horban, A., Andrade-Villanueva, J., Losso, M., Porteiro, N., ... MARCH Study Group (2018). Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study. HIV Medicine, 19(1), 65-71. https://doi.org/10.1111/hiv.12532