AustralieFrV1, PascalFrancis, Corpus, bibRecord, 003272

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

Identifieur interne : 003272 ( PascalFrancis/Corpus ); précédent : 003271; suivant : 003273

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

Auteurs : Gerd F Tkenheuer ; Mark Nelson ; Adriano Lazzarin ; Irina Konourina ; Andy I. M. Hoepelman ; Harry Lampiris ; Bernard Hirschel ; Pablo Tebas ; Francois Raffi ; Benoit Trottier ; Nicholaos Bellos ; Michael Saag ; David A. Cooper ; Mike Westby ; Margaret Tawadrous ; John F. Sullivan ; Caroline Ridgway ; Michael W. Dunne ; Steve Felstead ; Howard Mayer ; Elna Van Der Ryst

Source :

The New England journal of medicine [ 0028-4793 ] ; 2008.

RBID : Pascal:08-0478388

Descripteurs français

Pascal (Inist)
- Sous groupe, Maraviroc, Traitement, Virus HIV1, SIDA, Médecine, Antiviral, Antirétroviral.

English descriptors

KwdEn :
- AIDS, Antiretroviral agent, Antiviral, HIV-1 virus, Maraviroc, Medicine, Subgroup, Treatment.

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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C01	`01`		`ENG`	@0 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.
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Format Inist (serveur)

NO :	PASCAL 08-0478388 INIST
ET :	Subgroup Analyses of Maraviroc in Previously Treated R5 HIV-1 Infection
AU :	FÄTKENHEUER (Gerd); NELSON (Mark); LAZZARIN (Adriano); KONOURINA (Irina); HOEPELMAN (Andy I. M.); LAMPIRIS (Harry); HIRSCHEL (Bernard); TEBAS (Pablo); RAFFI (Francois); TROTTIER (Benoit); BELLOS (Nicholaos); SAAG (Michael); COOPER (David A.); WESTBY (Mike); TAWADROUS (Margaret); SULLIVAN (John F.); RIDGWAY (Caroline); DUNNE (Michael W.); FELSTEAD (Steve); MAYER (Howard); VAN DER RYST (Elna)
AF :	Universitätsklinik Köln/Cologne/Allemagne (1 aut.); Chelsea and Westminster Hospital/London/Royaume-Uni (2 aut.); Istituto di Ricerca e Cura a Carattere Scientifico San Raffaele/Milan/Italie (3 aut.); Pfizer Glob-al Research and Development/Sandwich/Royaume-Uni (4 aut., 14 aut., 16 aut., 17 aut., 19 aut., 21 aut.); University Medical Center Utrecht/Utrecht/Pays-Bas (5 aut.); University of California/San Francisco/Etats-Unis (6 aut.); San Francisco Veterans Affairs Medical Center/San Francisco/Etats-Unis (6 aut.); Geneva University Hospital/Geneva/Suisse (7 aut.); University of Pennsylvania/Philadelphia/Etats-Unis (8 aut.); University Hospital, Hôtel-Dieu, Medical University/Nantes/France (9 aut.); Clinique Médicale L'Actuel/Montreal/Canada (10 aut.); Southwest Infectious Disease Associates/Dallas/Etats-Unis (11 aut.); University of Alabama, Birmingham/Birmingham/Etats-Unis (12 aut.); National Centre in HIV Epidemiology and Clinical Research, University of New South Wales/Sydney/Australie (13 aut.); Pfizer Global Research and Development/New London, CT/Etats-Unis (15 aut., 18 aut., 20 aut.)
DT :	Publication en série; Niveau analytique
SO :	The New England journal of medicine; ISSN 0028-4793; Coden NEJMAG; Etats-Unis; Da. 2008; Vol. 359; No. 14; Pp. 1442-1455; Bibl. 35 ref.
LA :	Anglais
EA :	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.
CC :	002B01; 002B05C02D
FD :	Sous groupe; Maraviroc; Traitement; Virus HIV1; SIDA; Médecine; Antiviral; Antirétroviral
FG :	Virus immunodéficience humaine; Lentivirus; Retroviridae; Virus; Virose; Infection; Immunodéficit; Immunopathologie; Anti-CCR5; Inhibiteur d'entrée
ED :	Subgroup; Maraviroc; Treatment; HIV-1 virus; AIDS; Medicine; Antiviral; Antiretroviral agent
EG :	Human immunodeficiency virus; Lentivirus; Retroviridae; Virus; Viral disease; Infection; Immune deficiency; Immunopathology
SD :	Subgrupo; Maraviroc; Tratamiento; HIV-1 virus; SIDA; Medicina; Antiviral; Antiretroviral
LO :	INIST-6013.354000185657890040
ID :	08-0478388

Links to Exploration step

Pascal:08-0478388

Le document en format XML

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<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>16 aut.</sZ>
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<sZ>19 aut.</sZ>
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<s2>New London, CT</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
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</affiliation>
</author>
<author><name sortKey="Felstead, Steve" sort="Felstead, Steve" uniqKey="Felstead S" first="Steve" last="Felstead">Steve Felstead</name>
<affiliation><inist:fA14 i1="04"><s1>Pfizer Glob-al Research and Development</s1>
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<s3>GBR</s3>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>21 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Mayer, Howard" sort="Mayer, Howard" uniqKey="Mayer H" first="Howard" last="Mayer">Howard Mayer</name>
<affiliation><inist:fA14 i1="15"><s1>Pfizer Global Research and Development</s1>
<s2>New London, CT</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Van Der Ryst, Elna" sort="Van Der Ryst, Elna" uniqKey="Van Der Ryst E" first="Elna" last="Van Der Ryst">Elna Van Der Ryst</name>
<affiliation><inist:fA14 i1="04"><s1>Pfizer Glob-al Research and Development</s1>
<s2>Sandwich</s2>
<s3>GBR</s3>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>21 aut.</sZ>
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</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">08-0478388</idno>
<date when="2008">2008</date>
<idno type="stanalyst">PASCAL 08-0478388 INIST</idno>
<idno type="RBID">Pascal:08-0478388</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">003272</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Subgroup Analyses of Maraviroc in Previously Treated R5 HIV-1 Infection</title>
<author><name sortKey="F Tkenheuer, Gerd" sort="F Tkenheuer, Gerd" uniqKey="F Tkenheuer G" first="Gerd" last="F Tkenheuer">Gerd F Tkenheuer</name>
<affiliation><inist:fA14 i1="01"><s1>Universitätsklinik Köln</s1>
<s2>Cologne</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Nelson, Mark" sort="Nelson, Mark" uniqKey="Nelson M" first="Mark" last="Nelson">Mark Nelson</name>
<affiliation><inist:fA14 i1="02"><s1>Chelsea and Westminster Hospital</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Lazzarin, Adriano" sort="Lazzarin, Adriano" uniqKey="Lazzarin A" first="Adriano" last="Lazzarin">Adriano Lazzarin</name>
<affiliation><inist:fA14 i1="03"><s1>Istituto di Ricerca e Cura a Carattere Scientifico San Raffaele</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Konourina, Irina" sort="Konourina, Irina" uniqKey="Konourina I" first="Irina" last="Konourina">Irina Konourina</name>
<affiliation><inist:fA14 i1="04"><s1>Pfizer Glob-al Research and Development</s1>
<s2>Sandwich</s2>
<s3>GBR</s3>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>21 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Hoepelman, Andy I M" sort="Hoepelman, Andy I M" uniqKey="Hoepelman A" first="Andy I. M." last="Hoepelman">Andy I. M. Hoepelman</name>
<affiliation><inist:fA14 i1="05"><s1>University Medical Center Utrecht</s1>
<s2>Utrecht</s2>
<s3>NLD</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Lampiris, Harry" sort="Lampiris, Harry" uniqKey="Lampiris H" first="Harry" last="Lampiris">Harry Lampiris</name>
<affiliation><inist:fA14 i1="06"><s1>University of California</s1>
<s2>San Francisco</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="07"><s1>San Francisco Veterans Affairs Medical Center</s1>
<s2>San Francisco</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Hirschel, Bernard" sort="Hirschel, Bernard" uniqKey="Hirschel B" first="Bernard" last="Hirschel">Bernard Hirschel</name>
<affiliation><inist:fA14 i1="08"><s1>Geneva University Hospital</s1>
<s2>Geneva</s2>
<s3>CHE</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Tebas, Pablo" sort="Tebas, Pablo" uniqKey="Tebas P" first="Pablo" last="Tebas">Pablo Tebas</name>
<affiliation><inist:fA14 i1="09"><s1>University of Pennsylvania</s1>
<s2>Philadelphia</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Raffi, Francois" sort="Raffi, Francois" uniqKey="Raffi F" first="Francois" last="Raffi">Francois Raffi</name>
<affiliation><inist:fA14 i1="10"><s1>University Hospital, Hôtel-Dieu, Medical University</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Trottier, Benoit" sort="Trottier, Benoit" uniqKey="Trottier B" first="Benoit" last="Trottier">Benoit Trottier</name>
<affiliation><inist:fA14 i1="11"><s1>Clinique Médicale L'Actuel</s1>
<s2>Montreal</s2>
<s3>CAN</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Bellos, Nicholaos" sort="Bellos, Nicholaos" uniqKey="Bellos N" first="Nicholaos" last="Bellos">Nicholaos Bellos</name>
<affiliation><inist:fA14 i1="12"><s1>Southwest Infectious Disease Associates</s1>
<s2>Dallas</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Saag, Michael" sort="Saag, Michael" uniqKey="Saag M" first="Michael" last="Saag">Michael Saag</name>
<affiliation><inist:fA14 i1="13"><s1>University of Alabama, Birmingham</s1>
<s2>Birmingham</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Cooper, David A" sort="Cooper, David A" uniqKey="Cooper D" first="David A." last="Cooper">David A. Cooper</name>
<affiliation><inist:fA14 i1="14"><s1>National Centre in HIV Epidemiology and Clinical Research, University of New South Wales</s1>
<s2>Sydney</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Westby, Mike" sort="Westby, Mike" uniqKey="Westby M" first="Mike" last="Westby">Mike Westby</name>
<affiliation><inist:fA14 i1="04"><s1>Pfizer Glob-al Research and Development</s1>
<s2>Sandwich</s2>
<s3>GBR</s3>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>21 aut.</sZ>
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</author>
<author><name sortKey="Tawadrous, Margaret" sort="Tawadrous, Margaret" uniqKey="Tawadrous M" first="Margaret" last="Tawadrous">Margaret Tawadrous</name>
<affiliation><inist:fA14 i1="15"><s1>Pfizer Global Research and Development</s1>
<s2>New London, CT</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Sullivan, John F" sort="Sullivan, John F" uniqKey="Sullivan J" first="John F." last="Sullivan">John F. Sullivan</name>
<affiliation><inist:fA14 i1="04"><s1>Pfizer Glob-al Research and Development</s1>
<s2>Sandwich</s2>
<s3>GBR</s3>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>21 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Ridgway, Caroline" sort="Ridgway, Caroline" uniqKey="Ridgway C" first="Caroline" last="Ridgway">Caroline Ridgway</name>
<affiliation><inist:fA14 i1="04"><s1>Pfizer Glob-al Research and Development</s1>
<s2>Sandwich</s2>
<s3>GBR</s3>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>21 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Dunne, Michael W" sort="Dunne, Michael W" uniqKey="Dunne M" first="Michael W." last="Dunne">Michael W. Dunne</name>
<affiliation><inist:fA14 i1="15"><s1>Pfizer Global Research and Development</s1>
<s2>New London, CT</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Felstead, Steve" sort="Felstead, Steve" uniqKey="Felstead S" first="Steve" last="Felstead">Steve Felstead</name>
<affiliation><inist:fA14 i1="04"><s1>Pfizer Glob-al Research and Development</s1>
<s2>Sandwich</s2>
<s3>GBR</s3>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>21 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Mayer, Howard" sort="Mayer, Howard" uniqKey="Mayer H" first="Howard" last="Mayer">Howard Mayer</name>
<affiliation><inist:fA14 i1="15"><s1>Pfizer Global Research and Development</s1>
<s2>New London, CT</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Van Der Ryst, Elna" sort="Van Der Ryst, Elna" uniqKey="Van Der Ryst E" first="Elna" last="Van Der Ryst">Elna Van Der Ryst</name>
<affiliation><inist:fA14 i1="04"><s1>Pfizer Glob-al Research and Development</s1>
<s2>Sandwich</s2>
<s3>GBR</s3>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>16 aut.</sZ>
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</author>
</analytic>
<series><title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
<imprint><date when="2008">2008</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>AIDS</term>
<term>Antiretroviral agent</term>
<term>Antiviral</term>
<term>HIV-1 virus</term>
<term>Maraviroc</term>
<term>Medicine</term>
<term>Subgroup</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Sous groupe</term>
<term>Maraviroc</term>
<term>Traitement</term>
<term>Virus HIV1</term>
<term>SIDA</term>
<term>Médecine</term>
<term>Antiviral</term>
<term>Antirétroviral</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">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.</div>
</front>
</TEI>
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<fA05><s2>359</s2>
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<fA06><s2>14</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>Subgroup Analyses of Maraviroc in Previously Treated R5 HIV-1 Infection</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>FÄTKENHEUER (Gerd)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>NELSON (Mark)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>LAZZARIN (Adriano)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>KONOURINA (Irina)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>HOEPELMAN (Andy I. M.)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>LAMPIRIS (Harry)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>HIRSCHEL (Bernard)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>TEBAS (Pablo)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>RAFFI (Francois)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>TROTTIER (Benoit)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>BELLOS (Nicholaos)</s1>
</fA11>
<fA11 i1="12" i2="1"><s1>SAAG (Michael)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>COOPER (David A.)</s1>
</fA11>
<fA11 i1="14" i2="1"><s1>WESTBY (Mike)</s1>
</fA11>
<fA11 i1="15" i2="1"><s1>TAWADROUS (Margaret)</s1>
</fA11>
<fA11 i1="16" i2="1"><s1>SULLIVAN (John F.)</s1>
</fA11>
<fA11 i1="17" i2="1"><s1>RIDGWAY (Caroline)</s1>
</fA11>
<fA11 i1="18" i2="1"><s1>DUNNE (Michael W.)</s1>
</fA11>
<fA11 i1="19" i2="1"><s1>FELSTEAD (Steve)</s1>
</fA11>
<fA11 i1="20" i2="1"><s1>MAYER (Howard)</s1>
</fA11>
<fA11 i1="21" i2="1"><s1>VAN DER RYST (Elna)</s1>
</fA11>
<fA14 i1="01"><s1>Universitätsklinik Köln</s1>
<s2>Cologne</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Chelsea and Westminster Hospital</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Istituto di Ricerca e Cura a Carattere Scientifico San Raffaele</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Pfizer Glob-al Research and Development</s1>
<s2>Sandwich</s2>
<s3>GBR</s3>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>21 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>University Medical Center Utrecht</s1>
<s2>Utrecht</s2>
<s3>NLD</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>University of California</s1>
<s2>San Francisco</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>San Francisco Veterans Affairs Medical Center</s1>
<s2>San Francisco</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Geneva University Hospital</s1>
<s2>Geneva</s2>
<s3>CHE</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>University of Pennsylvania</s1>
<s2>Philadelphia</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>University Hospital, Hôtel-Dieu, Medical University</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>Clinique Médicale L'Actuel</s1>
<s2>Montreal</s2>
<s3>CAN</s3>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="12"><s1>Southwest Infectious Disease Associates</s1>
<s2>Dallas</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="13"><s1>University of Alabama, Birmingham</s1>
<s2>Birmingham</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="14"><s1>National Centre in HIV Epidemiology and Clinical Research, University of New South Wales</s1>
<s2>Sydney</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="15"><s1>Pfizer Global Research and Development</s1>
<s2>New London, CT</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>20 aut.</sZ>
</fA14>
<fA17 i1="01" i2="1"><s1>MOTIVATE 1 and MOTIVATE 2 Study Teams</s1>
<s3>INC</s3>
</fA17>
<fA20><s1>1442-1455</s1>
</fA20>
<fA21><s1>2008</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>6013</s2>
<s5>354000185657890040</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2008 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>35 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>08-0478388</s0>
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<server><NO>PASCAL 08-0478388 INIST</NO>
<ET>Subgroup Analyses of Maraviroc in Previously Treated R5 HIV-1 Infection</ET>
<AU>FÄTKENHEUER (Gerd); NELSON (Mark); LAZZARIN (Adriano); KONOURINA (Irina); HOEPELMAN (Andy I. M.); LAMPIRIS (Harry); HIRSCHEL (Bernard); TEBAS (Pablo); RAFFI (Francois); TROTTIER (Benoit); BELLOS (Nicholaos); SAAG (Michael); COOPER (David A.); WESTBY (Mike); TAWADROUS (Margaret); SULLIVAN (John F.); RIDGWAY (Caroline); DUNNE (Michael W.); FELSTEAD (Steve); MAYER (Howard); VAN DER RYST (Elna)</AU>
<AF>Universitätsklinik Köln/Cologne/Allemagne (1 aut.); Chelsea and Westminster Hospital/London/Royaume-Uni (2 aut.); Istituto di Ricerca e Cura a Carattere Scientifico San Raffaele/Milan/Italie (3 aut.); Pfizer Glob-al Research and Development/Sandwich/Royaume-Uni (4 aut., 14 aut., 16 aut., 17 aut., 19 aut., 21 aut.); University Medical Center Utrecht/Utrecht/Pays-Bas (5 aut.); University of California/San Francisco/Etats-Unis (6 aut.); San Francisco Veterans Affairs Medical Center/San Francisco/Etats-Unis (6 aut.); Geneva University Hospital/Geneva/Suisse (7 aut.); University of Pennsylvania/Philadelphia/Etats-Unis (8 aut.); University Hospital, Hôtel-Dieu, Medical University/Nantes/France (9 aut.); Clinique Médicale L'Actuel/Montreal/Canada (10 aut.); Southwest Infectious Disease Associates/Dallas/Etats-Unis (11 aut.); University of Alabama, Birmingham/Birmingham/Etats-Unis (12 aut.); National Centre in HIV Epidemiology and Clinical Research, University of New South Wales/Sydney/Australie (13 aut.); Pfizer Global Research and Development/New London, CT/Etats-Unis (15 aut., 18 aut., 20 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>The New England journal of medicine; ISSN 0028-4793; Coden NEJMAG; Etats-Unis; Da. 2008; Vol. 359; No. 14; Pp. 1442-1455; Bibl. 35 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B01; 002B05C02D</CC>
<FD>Sous groupe; Maraviroc; Traitement; Virus HIV1; SIDA; Médecine; Antiviral; Antirétroviral</FD>
<FG>Virus immunodéficience humaine; Lentivirus; Retroviridae; Virus; Virose; Infection; Immunodéficit; Immunopathologie; Anti-CCR5; Inhibiteur d'entrée</FG>
<ED>Subgroup; Maraviroc; Treatment; HIV-1 virus; AIDS; Medicine; Antiviral; Antiretroviral agent</ED>
<EG>Human immunodeficiency virus; Lentivirus; Retroviridae; Virus; Viral disease; Infection; Immune deficiency; Immunopathology</EG>
<SD>Subgrupo; Maraviroc; Tratamiento; HIV-1 virus; SIDA; Medicina; Antiviral; Antiretroviral</SD>
<LO>INIST-6013.354000185657890040</LO>
<ID>08-0478388</ID>
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Subgroup Analyses of Maraviroc in Previously Treated R5 HIV-1 Infection

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

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