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JAC Advance Access originally published online on April 18, 2009
Journal of Antimicrobial Chemotherapy 2009 63(6):1087-1096; doi:10.1093/jac/dkp113
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© The Author 2009. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Leading article

Maraviroc: perspectives for use in antiretroviral-naive HIV-1-infected patients

Linos Vandekerckhove1,2,*, Chris Verhofstede2 and Dirk Vogelaers1

1 AIDS Reference Centre, Gent University Hospital, De Pintelaan 185, 9000 Gent, Belgium 2 AIDS Reference Laboratory, Gent University, De Pintelaan 185, 9000 Gent, Belgium

* Corresponding author. Tel: +32-93323895; Fax: +32-93325690; E-mail: linos.vandekerckhove{at}ugent.be

Maraviroc (Pfizer's UK-427857, Selzentry or Celsentri outside the USA) is the first agent in the new class of oral HIV-1 entry inhibitors to acquire approval by the US Food and Drug Administration and the European Medicine Agency. Considering the mechanism of action, it is expected that this drug will be effective only in a subpopulation of HIV-1-infected people, namely those harbouring the R5 virus. The favourable toxicity profile of the drug has been demonstrated in Phase III clinical trials in treatment-naive (MERIT) and treatment-experienced (MOTIVATE) patients. In the latter population, maraviroc showed a superior antiviral efficacy and immunological activity compared with optimized backbone therapy + placebo. However, in MERIT, a prospective double-blind, randomized trial in treatment-naive patients, maraviroc + zidovudine/lamivudine failed to prove non-inferiority to efavirenz + zidovudine/lamivudine as standard of care regimen in the 48 week intention-to-treat analysis. Using an assay with higher sensitivity for minority CXCR4-using (X4) HIV variants (the enhanced TrofileTM assay—Monogram), non-inferiority was reached for the maraviroc- versus efavirenz-based combination. These data indicate the important impact of the sensitivity of tropism testing on treatment outcome of maraviroc-containing regimens. This paper discusses both the prospective and retrospective analyses of the MERIT data and highlights the impact of these results on daily practice in HIV care.

Keywords: antiretroviral-naive patients , chemokine receptor antagonist , MERIT


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