AustralieFrV1, Main, Exploration, bibRecord, 008A14

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

Identifieur interne : 008A14 ( Main/Exploration ); précédent : 008A13; suivant : 008A15

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

Auteurs : Gerd F Tkenheuer [Allemagne] ; Mark Nelson [Royaume-Uni] ; Adriano Lazzarin [Italie] ; Irina Konourina [Royaume-Uni] ; Andy I. M. Hoepelman [Pays-Bas] ; Harry Lampiris [États-Unis] ; Bernard Hirschel [Suisse] ; Pablo Tebas [États-Unis] ; Francois Raffi [France] ; Benoit Trottier [Canada] ; Nicholaos Bellos [États-Unis] ; Michael Saag [États-Unis] ; David A. Cooper [Australie] ; Mike Westby [Royaume-Uni] ; Margaret Tawadrous [États-Unis] ; John F. Sullivan [Royaume-Uni] ; Caroline Ridgway [Royaume-Uni] ; Michael W. Dunne [États-Unis] ; Steve Felstead [Royaume-Uni] ; Howard Mayer [États-Unis] ; Elna Van Der Ryst [Royaume-Uni]

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.
Wicri :
- topic : Médecine.

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.

Affiliations:

Allemagne, Australie, Canada, France, Italie, Pays-Bas, Royaume-Uni, Suisse, États-Unis
Angleterre, Californie, Grand Londres, Lombardie, Midlands de l'Ouest, Nouvelle-Galles du Sud, Pays de la Loire, Pennsylvanie, Québec, Texas, Utrecht (province)
Birmingham, Dallas, Londres, Milan, Montréal, Nantes, Philadelphie, San Francisco, Sydney, Utrecht

Links toward previous steps (curation, corpus...)

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to stream PascalFrancis, to step Curation: 002D81
to stream PascalFrancis, to step Checkpoint: 002E80
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Le document en format XML

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<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>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Subgroup Analyses of Maraviroc in Previously Treated R5 HIV-1 Infection</title>
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<author><name sortKey="Nelson, Mark" sort="Nelson, Mark" uniqKey="Nelson M" first="Mark" last="Nelson">Mark Nelson</name>
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<author><name sortKey="Lampiris, Harry" sort="Lampiris, Harry" uniqKey="Lampiris H" first="Harry" last="Lampiris">Harry Lampiris</name>
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<affiliation wicri:level="3"><inist:fA14 i1="09"><s1>University of Pennsylvania</s1>
<s2>Philadelphia</s2>
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<region type="state">Pennsylvanie</region>
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</affiliation>
</author>
<author><name sortKey="Raffi, Francois" sort="Raffi, Francois" uniqKey="Raffi F" first="Francois" last="Raffi">Francois Raffi</name>
<affiliation wicri:level="3"><inist:fA14 i1="10"><s1>University Hospital, Hôtel-Dieu, Medical University</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Pays de la Loire</region>
<region type="old region">Pays de la Loire</region>
<settlement type="city">Nantes</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Trottier, Benoit" sort="Trottier, Benoit" uniqKey="Trottier B" first="Benoit" last="Trottier">Benoit Trottier</name>
<affiliation wicri:level="3"><inist:fA14 i1="11"><s1>Clinique Médicale L'Actuel</s1>
<s2>Montreal</s2>
<s3>CAN</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<placeName><settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bellos, Nicholaos" sort="Bellos, Nicholaos" uniqKey="Bellos N" first="Nicholaos" last="Bellos">Nicholaos Bellos</name>
<affiliation wicri:level="3"><inist:fA14 i1="12"><s1>Southwest Infectious Disease Associates</s1>
<s2>Dallas</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Dallas</settlement>
<region type="state">Texas</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Saag, Michael" sort="Saag, Michael" uniqKey="Saag M" first="Michael" last="Saag">Michael Saag</name>
<affiliation wicri:level="3"><inist:fA14 i1="13"><s1>University of Alabama, Birmingham</s1>
<s2>Birmingham</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Birmingham</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Midlands de l'Ouest</region>
</placeName>
</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 wicri:level="3"><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>
<country>Australie</country>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Westby, Mike" sort="Westby, Mike" uniqKey="Westby M" first="Mike" last="Westby">Mike Westby</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Pfizer Glob-al Research and Development</s1>
<s2>Sandwich</s2>
<s3>GBR</s3>
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<country>Royaume-Uni</country>
<wicri:noRegion>Pfizer Glob-al Research and Development</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Tawadrous, Margaret" sort="Tawadrous, Margaret" uniqKey="Tawadrous M" first="Margaret" last="Tawadrous">Margaret Tawadrous</name>
<affiliation wicri:level="1"><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>
<country>États-Unis</country>
<wicri:noRegion>Pfizer Global Research and Development</wicri:noRegion>
</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 wicri:level="1"><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>
<country>Royaume-Uni</country>
<wicri:noRegion>Pfizer Glob-al Research and Development</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ridgway, Caroline" sort="Ridgway, Caroline" uniqKey="Ridgway C" first="Caroline" last="Ridgway">Caroline Ridgway</name>
<affiliation wicri:level="1"><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>
<country>Royaume-Uni</country>
<wicri:noRegion>Pfizer Glob-al Research and Development</wicri:noRegion>
</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 wicri:level="1"><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>
<country>États-Unis</country>
<wicri:noRegion>Pfizer Global Research and Development</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Felstead, Steve" sort="Felstead, Steve" uniqKey="Felstead S" first="Steve" last="Felstead">Steve Felstead</name>
<affiliation wicri:level="1"><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>
<country>Royaume-Uni</country>
<wicri:noRegion>Pfizer Glob-al Research and Development</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mayer, Howard" sort="Mayer, Howard" uniqKey="Mayer H" first="Howard" last="Mayer">Howard Mayer</name>
<affiliation wicri:level="1"><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>
<country>États-Unis</country>
<wicri:noRegion>Pfizer Global Research and Development</wicri:noRegion>
</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 wicri:level="1"><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>
<country>Royaume-Uni</country>
<wicri:noRegion>Pfizer Glob-al Research and Development</wicri:noRegion>
</affiliation>
</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>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</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>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Californie</li>
<li>Grand Londres</li>
<li>Lombardie</li>
<li>Midlands de l'Ouest</li>
<li>Nouvelle-Galles du Sud</li>
<li>Pays de la Loire</li>
<li>Pennsylvanie</li>
<li>Québec</li>
<li>Texas</li>
<li>Utrecht (province)</li>
</region>
<settlement><li>Birmingham</li>
<li>Dallas</li>
<li>Londres</li>
<li>Milan</li>
<li>Montréal</li>
<li>Nantes</li>
<li>Philadelphie</li>
<li>San Francisco</li>
<li>Sydney</li>
<li>Utrecht</li>
</settlement>
</list>
<tree><country name="Allemagne"><noRegion><name sortKey="F Tkenheuer, Gerd" sort="F Tkenheuer, Gerd" uniqKey="F Tkenheuer G" first="Gerd" last="F Tkenheuer">Gerd F Tkenheuer</name>
</noRegion>
</country>
<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Nelson, Mark" sort="Nelson, Mark" uniqKey="Nelson M" first="Mark" last="Nelson">Mark Nelson</name>
</region>
<name sortKey="Felstead, Steve" sort="Felstead, Steve" uniqKey="Felstead S" first="Steve" last="Felstead">Steve Felstead</name>
<name sortKey="Konourina, Irina" sort="Konourina, Irina" uniqKey="Konourina I" first="Irina" last="Konourina">Irina Konourina</name>
<name sortKey="Ridgway, Caroline" sort="Ridgway, Caroline" uniqKey="Ridgway C" first="Caroline" last="Ridgway">Caroline Ridgway</name>
<name sortKey="Sullivan, John F" sort="Sullivan, John F" uniqKey="Sullivan J" first="John F." last="Sullivan">John F. Sullivan</name>
<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>
<name sortKey="Westby, Mike" sort="Westby, Mike" uniqKey="Westby M" first="Mike" last="Westby">Mike Westby</name>
</country>
<country name="Italie"><region name="Lombardie"><name sortKey="Lazzarin, Adriano" sort="Lazzarin, Adriano" uniqKey="Lazzarin A" first="Adriano" last="Lazzarin">Adriano Lazzarin</name>
</region>
</country>
<country name="Pays-Bas"><region name="Utrecht (province)"><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>
</region>
</country>
<country name="États-Unis"><region name="Californie"><name sortKey="Lampiris, Harry" sort="Lampiris, Harry" uniqKey="Lampiris H" first="Harry" last="Lampiris">Harry Lampiris</name>
</region>
<name sortKey="Bellos, Nicholaos" sort="Bellos, Nicholaos" uniqKey="Bellos N" first="Nicholaos" last="Bellos">Nicholaos Bellos</name>
<name sortKey="Dunne, Michael W" sort="Dunne, Michael W" uniqKey="Dunne M" first="Michael W." last="Dunne">Michael W. Dunne</name>
<name sortKey="Lampiris, Harry" sort="Lampiris, Harry" uniqKey="Lampiris H" first="Harry" last="Lampiris">Harry Lampiris</name>
<name sortKey="Mayer, Howard" sort="Mayer, Howard" uniqKey="Mayer H" first="Howard" last="Mayer">Howard Mayer</name>
<name sortKey="Saag, Michael" sort="Saag, Michael" uniqKey="Saag M" first="Michael" last="Saag">Michael Saag</name>
<name sortKey="Tawadrous, Margaret" sort="Tawadrous, Margaret" uniqKey="Tawadrous M" first="Margaret" last="Tawadrous">Margaret Tawadrous</name>
<name sortKey="Tebas, Pablo" sort="Tebas, Pablo" uniqKey="Tebas P" first="Pablo" last="Tebas">Pablo Tebas</name>
</country>
<country name="Suisse"><noRegion><name sortKey="Hirschel, Bernard" sort="Hirschel, Bernard" uniqKey="Hirschel B" first="Bernard" last="Hirschel">Bernard Hirschel</name>
</noRegion>
</country>
<country name="France"><region name="Pays de la Loire"><name sortKey="Raffi, Francois" sort="Raffi, Francois" uniqKey="Raffi F" first="Francois" last="Raffi">Francois Raffi</name>
</region>
</country>
<country name="Canada"><region name="Québec"><name sortKey="Trottier, Benoit" sort="Trottier, Benoit" uniqKey="Trottier B" first="Benoit" last="Trottier">Benoit Trottier</name>
</region>
</country>
<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Cooper, David A" sort="Cooper, David A" uniqKey="Cooper D" first="David A." last="Cooper">David A. Cooper</name>
</region>
</country>
</tree>
</affiliations>
</record>

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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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