Subgroup Analyses of Maraviroc in Previously Treated R5 HIV-1 Infection

Gerd FÄTKENHEUER; Mark NELSON; Nicholaos BELLOS; Michael SAAG; David A COOPER; Mike WESTBY; Margaret TAWADROUS; John F SULLIVAN; Caroline RIDGWAY; Michael W DUNNE; Steve FELSTEAD; Howard MAYER; Adriano LAZZARIN; Elna VAN DER RYST; Irina KONOURINA; Andy I. M HOEPELMAN; Harry LAMPIRIS; Bernard HIRSCHEL; Pablo TEBAS; Francois RAFFI; Benoit TROTTIER; MOTIVATE 2 Study Team

doi:10.1056/NEJMoa0803154

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Subgroup Analyses of Maraviroc in Previously Treated R5 HIV-1 Infection

Journal article

Peer reviewed

Subgroup Analyses of Maraviroc in Previously Treated R5 HIV-1 Infection

Gerd FÄTKENHEUER, Mark NELSON, Nicholaos BELLOS, Michael SAAG, David A COOPER, Mike WESTBY, Margaret TAWADROUS, John F SULLIVAN, Caroline RIDGWAY, Michael W DUNNE, …

The New England journal of medicine, Vol.359(14), pp.1442-1455

2008

DOI: 10.1056/NEJMoa0803154

PMID: 18832245

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Abstract

BACKGROUND We conducted subanalyses of the combined results of the Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients (MOTIVATE) 1 and MOTIVATE 2 studies to better characterize the efficacy and safety of maraviroc in key subgroups of patients. METHODS We analyzed pooled data from week 48 from the two studies according to sex, race or ethnic group, clade, CC chemokine receptor 5 (CCR5) delta32 genotype, viral load at the time of screening, the use or nonuse of enfuvirtide in optimized background therapy (OBT), the baseline CD4 cell count, the number of active antiretroviral drugs coadministered, the first use of selected background agents, and tropism at baseline. Changes in viral tropism and the CD4 count at treatment failure were evaluated. Data on aminotransferase levels in patients coinfected with hepatitis B virus (HBV) or hepatitis C virus (HCV) were also analyzed. RESULTS A treatment benefit of maraviroc plus OBT over placebo plus OBT was shown in all subgroups, including patients with a low CD4 cell count at baseline, those with a high viral load at screening, and those who had not received active agents in OBT. Analyses of the virologic response according to the first use of selected background drugs showed the additional benefit of adding a potent new drug to maraviroc at the initiation of maraviroc therapy. More patients in whom maraviroc failed had a virus binding to the CXC chemokine receptor 4 (CXCR4) at failure, but there was no evidence of a decrease in the CD4 cell count at failure in such patients as compared with those in whom placebo failed. Subanalyses involving patients coinfected with HBV or HCV revealed no evidence of excess hepatotoxic effects as compared with baseline. CONCLUSIONS Subanalyses of pooled data from week 48 indicate that maraviroc provides a valuable treatment option for a wide spectrum of patients with R5 HIV-1 infection who have been treated previously.

Infectious Diseases

General aspects

Viral diseases

Viral diseases of the lymphoid tissue and the blood. Aids

Biological and medical sciences

Medical sciences

Human viral diseases

Details

Title: Subtitle: Subgroup Analyses of Maraviroc in Previously Treated R5 HIV-1 Infection
Creators: Gerd FÄTKENHEUER - Universitätsklinik Köln, Cologne, Germany
Mark NELSON - Chelsea and Westminster Hospital, London, United Kingdom
Nicholaos BELLOS - Southwest Infectious Disease Associates, Dallas, United States
Michael SAAG - University of Alabama, Birmingham, Birmingham, United States
David A COOPER - National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia
Mike WESTBY - Pfizer Glob-al Research and Development, Sandwich, United Kingdom
Margaret TAWADROUS - Pfizer Global Research and Development, New London, CT, United States
John F SULLIVAN - Pfizer Glob-al Research and Development, Sandwich, United Kingdom
Caroline RIDGWAY - Pfizer Glob-al Research and Development, Sandwich, United Kingdom
Michael W DUNNE - Pfizer Global Research and Development, New London, CT, United States
Steve FELSTEAD - Pfizer Glob-al Research and Development, Sandwich, United Kingdom
Howard MAYER - Pfizer Global Research and Development, New London, CT, United States
Adriano LAZZARIN - Istituto di Ricerca e Cura a Carattere Scientifico San Raffaele, Milan, Italy
Elna VAN DER RYST - Pfizer Glob-al Research and Development, Sandwich, United Kingdom
Irina KONOURINA - Pfizer Glob-al Research and Development, Sandwich, United Kingdom
Andy I. M HOEPELMAN - University Medical Center Utrecht, Utrecht, Netherlands
Harry LAMPIRIS - University of California, San Francisco, United States
Bernard HIRSCHEL - Geneva University Hospital, Geneva, Switzerland
Pablo TEBAS - University of Pennsylvania, Philadelphia, United States
Francois RAFFI - University Hospital, Hôtel-Dieu, Medical University, Nantes, France
Benoit TROTTIER - Clinique Médicale L'Actuel, Montreal, Canada
MOTIVATE 2 Study Team
Contributors: Jack Thomas Stapleton (Contributor) - University of Iowa, Internal Medicine
Resource Type: Journal article
Publication Details: The New England journal of medicine, Vol.359(14), pp.1442-1455
Publisher: Massachusetts Medical Society
DOI: 10.1056/NEJMoa0803154
PMID: 18832245
ISSN: 0028-4793
eISSN: 1533-4406
Language: English
Date published: 2008
Academic Unit: Microbiology and Immunology; Infectious Diseases; Internal Medicine
Record Identifier: 9984094709502771

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