Universität zu Köln

Pett, S. L., Amin, J., Horban, A., Andrade-Villanueva, J., Losso, M., Porteiro, N., Madero, J. S., Belloso, W., Tu, E., Silk, D., Kelleher, A., Harrigan, R., Clark, A., Sugiura, W., Wolff, M., Gill, J., Gatell, J., Clarke, A., Ruxrungtham, K., Prazuck, T., Kaiser, R., Woolley, I., Alberto Arnaiz, J., Cooper, D., Rockstroh, J. K., Mallon, P. and Emery, S. (2018). Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study. HIV Med., 19 (1). S. 65 - 72. HOBOKEN: WILEY. ISSN 1468-1293

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Abstract

ObjectivesThe 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. MethodsMARCH, 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. ResultsEighty-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. ConclusionsMVC as a switch for a PI/r is safe and effective at maintaining virological suppression while having significant lipid benefits over 96 weeks.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Pett, S. L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Amin, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Horban, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Andrade-Villanueva, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Losso, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Porteiro, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Madero, J. S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Belloso, W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Tu, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Silk, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kelleher, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Harrigan, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Clark, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sugiura, W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wolff, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gill, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gatell, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Clarke, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruxrungtham, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Prazuck, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaiser, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Woolley, I. UNSPECIFIED UNSPECIFIED UNSPECIFIED Alberto Arnaiz, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cooper, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rockstroh, J. K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mallon, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Emery, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-205165
DOI:	10.1111/hiv.12532
Journal or Publication Title:	HIV Med.
Volume:	19
Number:	1
Page Range:	S. 65 - 72
Date:	2018
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1468-1293
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language THERAPY; STATE Multiple languages Infectious Diseases Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/20516