Efficacy, Safety, and Tolerability of Etravirine With and Without Darunavir/Ritonavir or Raltegravir in Treatment-Experienced Patients: Analysis of the Etravirine Early Access Program in the United States
Identifieur interne : 001049 ( Main/Exploration ); précédent : 001048; suivant : 001050Efficacy, Safety, and Tolerability of Etravirine With and Without Darunavir/Ritonavir or Raltegravir in Treatment-Experienced Patients: Analysis of the Etravirine Early Access Program in the United States
Auteurs : William Towner [États-Unis] ; Jacob Lalezari [États-Unis] ; Michael G. Sension [États-Unis] ; Michael Wohlfeiler [États-Unis] ; Joseph Gathe [États-Unis] ; Jonathan S. Appelbaum [États-Unis] ; Paul Bellman [États-Unis] ; Michael S. Gottlieb [États-Unis] ; Robert Ryan [États-Unis] ; Steven Nijs [Belgique] ; Annemie Hoogstoel [Belgique] ; Rodica Van Solingen-Ristea [Belgique] ; James Witek [États-Unis]Source :
- Journal of acquired immune deficiency syndromes : (1999) [ 1525-4135 ] ; 2010.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
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Abstract
Background: Etravirine, a nonnucleoside reverse transcriptase inhibitor, was provided through an international early access program (EAP) prior to regulatory approval. Methods: The Phase III, nonrandomized, open-label EAP investigated etravirine 200 mg twice daily plus a background regimen (BR) in patients who had failed multiple antiretroviral regimens. Efficacy and safety are reported for HIV-infected adults from the United States through week 48, including subgroups receiving etravirine ± darunavir/ritonavir and/or raltegravir. Results: The intent-to-treat population included 2578 patients; 62.4% and 56.7% of patients received darunavir/ritonavir and raltegravir, respectively, in their BR. At week 48, 62.3% of patients achieved viral loads <75 copies per milliliter; responses across subgroups were similar. Median CD4+ count increase from baseline was > 100 cells per cubic millimeter. No unexpected safety concerns emerged; serious AEs and deaths due to AEs, considered possibly related to etravirine, occurred in 2.0% and 0.3% of patients, respectively. Discontinuations due to AEs were low overall (4.4%) and comparable across subgroups. Conclusions: Etravirine combined with a BR, often including other new antiretrovirals, such as darunavir/ritonavir and/or raltegravir, provided an effective treatment option in treatment-experienced patients with HIV-1.
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Efficacy, Safety, and Tolerability of Etravirine With and Without Darunavir/Ritonavir or Raltegravir in Treatment-Experienced Patients: Analysis of the Etravirine Early Access Program in the United States</title><author><name sortKey="Towner, William" sort="Towner, William" uniqKey="Towner W" first="William" last="Towner">William Towner</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Kaiser Permanente-Infectious Diseases</s1><s2>Los Angeles, CA</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Lalezari, Jacob" sort="Lalezari, Jacob" uniqKey="Lalezari J" first="Jacob" last="Lalezari">Jacob Lalezari</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Quest Clinical Research</s1><s2>San Francisco, CA</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Sension, Michael G" sort="Sension, Michael G" uniqKey="Sension M" first="Michael G." last="Sension">Michael G. Sension</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>North Broward Hospital District</s1><s2>Fort Lauderdale, FL</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Wohlfeiler, Michael" sort="Wohlfeiler, Michael" uniqKey="Wohlfeiler M" first="Michael" last="Wohlfeiler">Michael Wohlfeiler</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Wohlfeiler, Piperato and Associates LLC</s1><s2>North Miami Beach, FL</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Gathe, Joseph" sort="Gathe, Joseph" uniqKey="Gathe J" first="Joseph" last="Gathe">Joseph Gathe</name><affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Therapeutic Concepts</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Appelbaum, Jonathan S" sort="Appelbaum, Jonathan S" uniqKey="Appelbaum J" first="Jonathan S." last="Appelbaum">Jonathan S. Appelbaum</name><affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Community Research Initiative of New England</s1><s2>Boston, MA</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Bellman, Paul" sort="Bellman, Paul" uniqKey="Bellman P" first="Paul" last="Bellman">Paul Bellman</name><affiliation wicri:level="2"><inist:fA14 i1="07"><s1>Office of Paul Bellman, MD</s1><s2>New York, NY</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Gottlieb, Michael S" sort="Gottlieb, Michael S" uniqKey="Gottlieb M" first="Michael S." last="Gottlieb">Michael S. Gottlieb</name><affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Synergy Hematology/Oncology</s1><s2>Los Angeles, CA</s2><s3>USA</s3><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Ryan, Robert" sort="Ryan, Robert" uniqKey="Ryan R" first="Robert" last="Ryan">Robert Ryan</name><affiliation wicri:level="2"><inist:fA14 i1="09"><s1>Tibotec, Inc</s1><s2>Titusville, NJ</s2><s3>USA</s3><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Nijs, Steven" sort="Nijs, Steven" uniqKey="Nijs S" first="Steven" last="Nijs">Steven Nijs</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Tibotec BVBA</s1><s2>Mechelen</s2><s3>BEL</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Tibotec BVBA</wicri:noRegion></affiliation></author><author><name sortKey="Hoogstoel, Annemie" sort="Hoogstoel, Annemie" uniqKey="Hoogstoel A" first="Annemie" last="Hoogstoel">Annemie Hoogstoel</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Tibotec BVBA</s1><s2>Mechelen</s2><s3>BEL</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Tibotec BVBA</wicri:noRegion></affiliation></author><author><name sortKey="Van Solingen Ristea, Rodica" sort="Van Solingen Ristea, Rodica" uniqKey="Van Solingen Ristea R" first="Rodica" last="Van Solingen-Ristea">Rodica Van Solingen-Ristea</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Tibotec BVBA</s1><s2>Mechelen</s2><s3>BEL</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Tibotec BVBA</wicri:noRegion></affiliation></author><author><name sortKey="Witek, James" sort="Witek, James" uniqKey="Witek J" first="James" last="Witek">James Witek</name><affiliation wicri:level="2"><inist:fA14 i1="11"><s1>Tibotec Therapeutics</s1><s2>Titusville, NJ</s2><s3>USA</s3><sZ>13 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">10-0196970</idno><date when="2010">2010</date><idno type="stanalyst">PASCAL 10-0196970 INIST</idno><idno type="RBID">Pascal:10-0196970</idno><idno type="wicri:Area/PascalFrancis/Corpus">000056</idno><idno type="wicri:Area/PascalFrancis/Curation">000090</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000042</idno><idno type="wicri:doubleKey">1525-4135:2010:Towner W:efficacy:safety:and</idno><idno type="wicri:Area/Main/Merge">001051</idno><idno type="wicri:Area/Main/Curation">001049</idno><idno type="wicri:Area/Main/Exploration">001049</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Efficacy, Safety, and Tolerability of Etravirine With and Without Darunavir/Ritonavir or Raltegravir in Treatment-Experienced Patients: Analysis of the Etravirine Early Access Program in the United States</title><author><name sortKey="Towner, William" sort="Towner, William" uniqKey="Towner W" first="William" last="Towner">William Towner</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Kaiser Permanente-Infectious Diseases</s1><s2>Los Angeles, CA</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Lalezari, Jacob" sort="Lalezari, Jacob" uniqKey="Lalezari J" first="Jacob" last="Lalezari">Jacob Lalezari</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Quest Clinical Research</s1><s2>San Francisco, CA</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Sension, Michael G" sort="Sension, Michael G" uniqKey="Sension M" first="Michael G." last="Sension">Michael G. Sension</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>North Broward Hospital District</s1><s2>Fort Lauderdale, FL</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Wohlfeiler, Michael" sort="Wohlfeiler, Michael" uniqKey="Wohlfeiler M" first="Michael" last="Wohlfeiler">Michael Wohlfeiler</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Wohlfeiler, Piperato and Associates LLC</s1><s2>North Miami Beach, FL</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Gathe, Joseph" sort="Gathe, Joseph" uniqKey="Gathe J" first="Joseph" last="Gathe">Joseph Gathe</name><affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Therapeutic Concepts</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Appelbaum, Jonathan S" sort="Appelbaum, Jonathan S" uniqKey="Appelbaum J" first="Jonathan S." last="Appelbaum">Jonathan S. Appelbaum</name><affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Community Research Initiative of New England</s1><s2>Boston, MA</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Bellman, Paul" sort="Bellman, Paul" uniqKey="Bellman P" first="Paul" last="Bellman">Paul Bellman</name><affiliation wicri:level="2"><inist:fA14 i1="07"><s1>Office of Paul Bellman, MD</s1><s2>New York, NY</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Gottlieb, Michael S" sort="Gottlieb, Michael S" uniqKey="Gottlieb M" first="Michael S." last="Gottlieb">Michael S. Gottlieb</name><affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Synergy Hematology/Oncology</s1><s2>Los Angeles, CA</s2><s3>USA</s3><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Ryan, Robert" sort="Ryan, Robert" uniqKey="Ryan R" first="Robert" last="Ryan">Robert Ryan</name><affiliation wicri:level="2"><inist:fA14 i1="09"><s1>Tibotec, Inc</s1><s2>Titusville, NJ</s2><s3>USA</s3><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Nijs, Steven" sort="Nijs, Steven" uniqKey="Nijs S" first="Steven" last="Nijs">Steven Nijs</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Tibotec BVBA</s1><s2>Mechelen</s2><s3>BEL</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Tibotec BVBA</wicri:noRegion></affiliation></author><author><name sortKey="Hoogstoel, Annemie" sort="Hoogstoel, Annemie" uniqKey="Hoogstoel A" first="Annemie" last="Hoogstoel">Annemie Hoogstoel</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Tibotec BVBA</s1><s2>Mechelen</s2><s3>BEL</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Tibotec BVBA</wicri:noRegion></affiliation></author><author><name sortKey="Van Solingen Ristea, Rodica" sort="Van Solingen Ristea, Rodica" uniqKey="Van Solingen Ristea R" first="Rodica" last="Van Solingen-Ristea">Rodica Van Solingen-Ristea</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Tibotec BVBA</s1><s2>Mechelen</s2><s3>BEL</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Tibotec BVBA</wicri:noRegion></affiliation></author><author><name sortKey="Witek, James" sort="Witek, James" uniqKey="Witek J" first="James" last="Witek">James Witek</name><affiliation wicri:level="2"><inist:fA14 i1="11"><s1>Tibotec Therapeutics</s1><s2>Titusville, NJ</s2><s3>USA</s3><sZ>13 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Journal of acquired immune deficiency syndromes : (1999)</title><title level="j" type="abbreviated">J. acquir. immune defic. syndr. : (1999)</title><idno type="ISSN">1525-4135</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of acquired immune deficiency syndromes : (1999)</title><title level="j" type="abbreviated">J. acquir. immune defic. syndr. : (1999)</title><idno type="ISSN">1525-4135</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral</term><term>Darunavir</term><term>Efficiency</term><term>Etravirine</term><term>Human</term><term>Raltegravir</term><term>Reverse transcriptase inhibitor</term><term>Ritonavir</term><term>Treatment</term><term>United States</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Homme</term><term>Efficacité</term><term>Ritonavir</term><term>Raltégravir</term><term>Traitement</term><term>Etats-Unis</term><term>Inhibiteur reverse transcriptase</term><term>Etravirine</term><term>Darunavir</term><term>Antiviral</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: Etravirine, a nonnucleoside reverse transcriptase inhibitor, was provided through an international early access program (EAP) prior to regulatory approval. Methods: The Phase III, nonrandomized, open-label EAP investigated etravirine 200 mg twice daily plus a background regimen (BR) in patients who had failed multiple antiretroviral regimens. Efficacy and safety are reported for HIV-infected adults from the United States through week 48, including subgroups receiving etravirine ± darunavir/ritonavir and/or raltegravir. Results: The intent-to-treat population included 2578 patients; 62.4% and 56.7% of patients received darunavir/ritonavir and raltegravir, respectively, in their BR. At week 48, 62.3% of patients achieved viral loads <75 copies per milliliter; responses across subgroups were similar. Median CD4<sup>+</sup> count increase from baseline was > 100 cells per cubic millimeter. No unexpected safety concerns emerged; serious AEs and deaths due to AEs, considered possibly related to etravirine, occurred in 2.0% and 0.3% of patients, respectively. Discontinuations due to AEs were low overall (4.4%) and comparable across subgroups. Conclusions: Etravirine combined with a BR, often including other new antiretrovirals, such as darunavir/ritonavir and/or raltegravir, provided an effective treatment option in treatment-experienced patients with HIV-1.</div></front></TEI><affiliations><list><country><li>Belgique</li><li>États-Unis</li></country><region><li>Californie</li><li>Floride</li><li>Massachusetts</li><li>New Jersey</li><li>Texas</li><li>État de New York</li></region></list><tree><country name="États-Unis"><region name="Californie"><name sortKey="Towner, William" sort="Towner, William" uniqKey="Towner W" first="William" last="Towner">William Towner</name></region><name sortKey="Appelbaum, Jonathan S" sort="Appelbaum, Jonathan S" uniqKey="Appelbaum J" first="Jonathan S." last="Appelbaum">Jonathan S. Appelbaum</name><name sortKey="Bellman, Paul" sort="Bellman, Paul" uniqKey="Bellman P" first="Paul" last="Bellman">Paul Bellman</name><name sortKey="Gathe, Joseph" sort="Gathe, Joseph" uniqKey="Gathe J" first="Joseph" last="Gathe">Joseph Gathe</name><name sortKey="Gottlieb, Michael S" sort="Gottlieb, Michael S" uniqKey="Gottlieb M" first="Michael S." last="Gottlieb">Michael S. Gottlieb</name><name sortKey="Lalezari, Jacob" sort="Lalezari, Jacob" uniqKey="Lalezari J" first="Jacob" last="Lalezari">Jacob Lalezari</name><name sortKey="Ryan, Robert" sort="Ryan, Robert" uniqKey="Ryan R" first="Robert" last="Ryan">Robert Ryan</name><name sortKey="Sension, Michael G" sort="Sension, Michael G" uniqKey="Sension M" first="Michael G." last="Sension">Michael G. Sension</name><name sortKey="Witek, James" sort="Witek, James" uniqKey="Witek J" first="James" last="Witek">James Witek</name><name sortKey="Wohlfeiler, Michael" sort="Wohlfeiler, Michael" uniqKey="Wohlfeiler M" first="Michael" last="Wohlfeiler">Michael Wohlfeiler</name></country><country name="Belgique"><noRegion><name sortKey="Nijs, Steven" sort="Nijs, Steven" uniqKey="Nijs S" first="Steven" last="Nijs">Steven Nijs</name></noRegion><name sortKey="Hoogstoel, Annemie" sort="Hoogstoel, Annemie" uniqKey="Hoogstoel A" first="Annemie" last="Hoogstoel">Annemie Hoogstoel</name><name sortKey="Van Solingen Ristea, Rodica" sort="Van Solingen Ristea, Rodica" uniqKey="Van Solingen Ristea R" first="Rodica" last="Van Solingen-Ristea">Rodica Van Solingen-Ristea</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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