OpenAccessBelV2, PascalFrancis, Corpus, bibRecord, 000056

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 : 000056 ( PascalFrancis/Corpus ); précédent : 000055; suivant : 000057

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

Auteurs : William Towner ; Jacob Lalezari ; Michael G. Sension ; Michael Wohlfeiler ; Joseph Gathe ; Jonathan S. Appelbaum ; Paul Bellman ; Michael S. Gottlieb ; Robert Ryan ; Steven Nijs ; Annemie Hoogstoel ; Rodica Van Solingen-Ristea ; James Witek

Source :

Journal of acquired immune deficiency syndromes : (1999) [ 1525-4135 ] ; 2010.

RBID : Pascal:10-0196970

Descripteurs français

Pascal (Inist)
- Homme, Efficacité, Ritonavir, Raltégravir, Traitement, Etats-Unis, Inhibiteur reverse transcriptase, Etravirine, Darunavir, Antiviral.

English descriptors

KwdEn :
- Antiviral, Darunavir, Efficiency, Etravirine, Human, Raltegravir, Reverse transcriptase inhibitor, Ritonavir, Treatment, United States.

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

A01	`01`	`1`		`@0 1525-4135`
A03		`1`		`@0 J. acquir. immune defic. syndr. : (1999)`
A05				`@2 53`
A06				`@2 5`
A08	`01`	`1`	`ENG`	`@1 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`
A11	`01`	`1`		`@1 TOWNER (William)`
A11	`02`	`1`		`@1 LALEZARI (Jacob)`
A11	`03`	`1`		`@1 SENSION (Michael G.)`
A11	`04`	`1`		`@1 WOHLFEILER (Michael)`
A11	`05`	`1`		`@1 GATHE (Joseph)`
A11	`06`	`1`		`@1 APPELBAUM (Jonathan S.)`
A11	`07`	`1`		`@1 BELLMAN (Paul)`
A11	`08`	`1`		`@1 GOTTLIEB (Michael S.)`
A11	`09`	`1`		`@1 RYAN (Robert)`
A11	`10`	`1`		`@1 NIJS (Steven)`
A11	`11`	`1`		`@1 HOOGSTOEL (Annemie)`
A11	`12`	`1`		`@1 VAN SOLINGEN-RISTEA (Rodica)`
A11	`13`	`1`		`@1 WITEK (James)`
A14	`01`			`@1 Kaiser Permanente-Infectious Diseases @2 Los Angeles, CA @3 USA @Z 1 aut.`
A14	`02`			`@1 Quest Clinical Research @2 San Francisco, CA @3 USA @Z 2 aut.`
A14	`03`			`@1 North Broward Hospital District @2 Fort Lauderdale, FL @3 USA @Z 3 aut.`
A14	`04`			`@1 Wohlfeiler, Piperato and Associates LLC @2 North Miami Beach, FL @3 USA @Z 4 aut.`
A14	`05`			`@1 Therapeutic Concepts @2 Houston, TX @3 USA @Z 5 aut.`
A14	`06`			`@1 Community Research Initiative of New England @2 Boston, MA @3 USA @Z 6 aut.`
A14	`07`			`@1 Office of Paul Bellman, MD @2 New York, NY @3 USA @Z 7 aut.`
A14	`08`			`@1 Synergy Hematology/Oncology @2 Los Angeles, CA @3 USA @Z 8 aut.`
A14	`09`			`@1 Tibotec, Inc @2 Titusville, NJ @3 USA @Z 9 aut.`
A14	`10`			`@1 Tibotec BVBA @2 Mechelen @3 BEL @Z 10 aut. @Z 11 aut. @Z 12 aut.`
A14	`11`			`@1 Tibotec Therapeutics @2 Titusville, NJ @3 USA @Z 13 aut.`
A20				`@1 614-618`
A21				`@1 2010`
A23	`01`			`@0 ENG`
A43	`01`			`@1 INIST @2 21576 @5 354000181928160080`
A44				`@0 0000 @1 © 2010 INIST-CNRS. All rights reserved.`
A45				`@0 8 ref.`
A47	`01`	`1`		`@0 10-0196970`
A60				`@1 P`
A61				`@0 A`
A64	`01`	`1`		`@0 Journal of acquired immune deficiency syndromes : (1999)`
A66	`01`			`@0 USA`
C01	`01`		`ENG`	@0 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.
C02	`01`	`X`		`@0 002A05C10`
C02	`02`	`X`		`@0 002B05C02J`
C03	`01`	`X`	`FRE`	`@0 Homme @5 01`
C03	`01`	`X`	`ENG`	`@0 Human @5 01`
C03	`01`	`X`	`SPA`	`@0 Hombre @5 01`
C03	`02`	`X`	`FRE`	`@0 Efficacité @5 05`
C03	`02`	`X`	`ENG`	`@0 Efficiency @5 05`
C03	`02`	`X`	`SPA`	`@0 Eficacia @5 05`
C03	`03`	`X`	`FRE`	`@0 Ritonavir @2 NK @2 FR @5 06`
C03	`03`	`X`	`ENG`	`@0 Ritonavir @2 NK @2 FR @5 06`
C03	`03`	`X`	`SPA`	`@0 Ritonavir @2 NK @2 FR @5 06`
C03	`04`	`X`	`FRE`	`@0 Raltégravir @2 FR @5 07`
C03	`04`	`X`	`ENG`	`@0 Raltegravir @2 FR @5 07`
C03	`04`	`X`	`SPA`	`@0 Raltegravir @2 FR @5 07`
C03	`05`	`X`	`FRE`	`@0 Traitement @5 08`
C03	`05`	`X`	`ENG`	`@0 Treatment @5 08`
C03	`05`	`X`	`SPA`	`@0 Tratamiento @5 08`
C03	`06`	`X`	`FRE`	`@0 Etats-Unis @2 NG @5 09`
C03	`06`	`X`	`ENG`	`@0 United States @2 NG @5 09`
C03	`06`	`X`	`SPA`	`@0 Estados Unidos @2 NG @5 09`
C03	`07`	`X`	`FRE`	`@0 Inhibiteur reverse transcriptase @2 NK @2 FR @5 10`
C03	`07`	`X`	`ENG`	`@0 Reverse transcriptase inhibitor @2 NK @2 FR @5 10`
C03	`07`	`X`	`SPA`	`@0 Inhibitor reverse transcriptase @2 NK @2 FR @5 10`
C03	`08`	`X`	`FRE`	`@0 Etravirine @2 FR @5 14`
C03	`08`	`X`	`ENG`	`@0 Etravirine @2 FR @5 14`
C03	`08`	`X`	`SPA`	`@0 Etravirina @2 FR @5 14`
C03	`09`	`X`	`FRE`	`@0 Darunavir @2 FR @5 15`
C03	`09`	`X`	`ENG`	`@0 Darunavir @2 FR @5 15`
C03	`09`	`X`	`SPA`	`@0 Darunavir @2 FR @5 15`
C03	`10`	`X`	`FRE`	`@0 Antiviral @5 45`
C03	`10`	`X`	`ENG`	`@0 Antiviral @5 45`
C03	`10`	`X`	`SPA`	`@0 Antiviral @5 45`
C07	`01`	`X`	`FRE`	`@0 Amérique du Nord @2 NG`
C07	`01`	`X`	`ENG`	`@0 North America @2 NG`
C07	`01`	`X`	`SPA`	`@0 America del norte @2 NG`
C07	`02`	`X`	`FRE`	`@0 Amérique @2 NG`
C07	`02`	`X`	`ENG`	`@0 America @2 NG`
C07	`02`	`X`	`SPA`	`@0 America @2 NG`
N21				`@1 130`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

Format Inist (serveur)

NO :	PASCAL 10-0196970 INIST
ET :	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
AU :	TOWNER (William); LALEZARI (Jacob); SENSION (Michael G.); WOHLFEILER (Michael); GATHE (Joseph); APPELBAUM (Jonathan S.); BELLMAN (Paul); GOTTLIEB (Michael S.); RYAN (Robert); NIJS (Steven); HOOGSTOEL (Annemie); VAN SOLINGEN-RISTEA (Rodica); WITEK (James)
AF :	Kaiser Permanente-Infectious Diseases/Los Angeles, CA/Etats-Unis (1 aut.); Quest Clinical Research/San Francisco, CA/Etats-Unis (2 aut.); North Broward Hospital District/Fort Lauderdale, FL/Etats-Unis (3 aut.); Wohlfeiler, Piperato and Associates LLC/North Miami Beach, FL/Etats-Unis (4 aut.); Therapeutic Concepts/Houston, TX/Etats-Unis (5 aut.); Community Research Initiative of New England/Boston, MA/Etats-Unis (6 aut.); Office of Paul Bellman, MD/New York, NY/Etats-Unis (7 aut.); Synergy Hematology/Oncology/Los Angeles, CA/Etats-Unis (8 aut.); Tibotec, Inc/Titusville, NJ/Etats-Unis (9 aut.); Tibotec BVBA/Mechelen/Belgique (10 aut., 11 aut., 12 aut.); Tibotec Therapeutics/Titusville, NJ/Etats-Unis (13 aut.)
DT :	Publication en série; Niveau analytique
SO :	Journal of acquired immune deficiency syndromes : (1999); ISSN 1525-4135; Etats-Unis; Da. 2010; Vol. 53; No. 5; Pp. 614-618; Bibl. 8 ref.
LA :	Anglais
EA :	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.
CC :	002A05C10; 002B05C02J
FD :	Homme; Efficacité; Ritonavir; Raltégravir; Traitement; Etats-Unis; Inhibiteur reverse transcriptase; Etravirine; Darunavir; Antiviral
FG :	Amérique du Nord; Amérique
ED :	Human; Efficiency; Ritonavir; Raltegravir; Treatment; United States; Reverse transcriptase inhibitor; Etravirine; Darunavir; Antiviral
EG :	North America; America
SD :	Hombre; Eficacia; Ritonavir; Raltegravir; Tratamiento; Estados Unidos; Inhibitor reverse transcriptase; Etravirina; Darunavir; Antiviral
LO :	INIST-21576.354000181928160080
ID :	10-0196970

Links to Exploration step

Pascal:10-0196970

Le document en format XML

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<author><name sortKey="Hoogstoel, Annemie" sort="Hoogstoel, Annemie" uniqKey="Hoogstoel A" first="Annemie" last="Hoogstoel">Annemie Hoogstoel</name>
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<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>
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<author><name sortKey="Witek, James" sort="Witek, James" uniqKey="Witek J" first="James" last="Witek">James Witek</name>
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<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>
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<author><name sortKey="Sension, Michael G" sort="Sension, Michael G" uniqKey="Sension M" first="Michael G." last="Sension">Michael G. Sension</name>
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<author><name sortKey="Wohlfeiler, Michael" sort="Wohlfeiler, Michael" uniqKey="Wohlfeiler M" first="Michael" last="Wohlfeiler">Michael Wohlfeiler</name>
<affiliation><inist:fA14 i1="04"><s1>Wohlfeiler, Piperato and Associates LLC</s1>
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<author><name sortKey="Gathe, Joseph" sort="Gathe, Joseph" uniqKey="Gathe J" first="Joseph" last="Gathe">Joseph Gathe</name>
<affiliation><inist:fA14 i1="05"><s1>Therapeutic Concepts</s1>
<s2>Houston, TX</s2>
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</inist:fA14>
</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><inist:fA14 i1="06"><s1>Community Research Initiative of New England</s1>
<s2>Boston, MA</s2>
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</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Bellman, Paul" sort="Bellman, Paul" uniqKey="Bellman P" first="Paul" last="Bellman">Paul Bellman</name>
<affiliation><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>
</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><inist:fA14 i1="08"><s1>Synergy Hematology/Oncology</s1>
<s2>Los Angeles, CA</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Ryan, Robert" sort="Ryan, Robert" uniqKey="Ryan R" first="Robert" last="Ryan">Robert Ryan</name>
<affiliation><inist:fA14 i1="09"><s1>Tibotec, Inc</s1>
<s2>Titusville, NJ</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Nijs, Steven" sort="Nijs, Steven" uniqKey="Nijs S" first="Steven" last="Nijs">Steven Nijs</name>
<affiliation><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>
</affiliation>
</author>
<author><name sortKey="Hoogstoel, Annemie" sort="Hoogstoel, Annemie" uniqKey="Hoogstoel A" first="Annemie" last="Hoogstoel">Annemie Hoogstoel</name>
<affiliation><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>
</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><inist:fA14 i1="10"><s1>Tibotec BVBA</s1>
<s2>Mechelen</s2>
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<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
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<author><name sortKey="Witek, James" sort="Witek, James" uniqKey="Witek J" first="James" last="Witek">James Witek</name>
<affiliation><inist:fA14 i1="11"><s1>Tibotec Therapeutics</s1>
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<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>
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<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>
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<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>
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<keywords scheme="Pascal" xml:lang="fr"><term>Homme</term>
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<term>Raltégravir</term>
<term>Traitement</term>
<term>Etats-Unis</term>
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<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>
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<fA08 i1="01" i2="1" l="ENG"><s1>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</s1>
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<fA11 i1="06" i2="1"><s1>APPELBAUM (Jonathan S.)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>BELLMAN (Paul)</s1>
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<fA11 i1="08" i2="1"><s1>GOTTLIEB (Michael S.)</s1>
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<fA11 i1="09" i2="1"><s1>RYAN (Robert)</s1>
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<fA11 i1="10" i2="1"><s1>NIJS (Steven)</s1>
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<fA11 i1="11" i2="1"><s1>HOOGSTOEL (Annemie)</s1>
</fA11>
<fA11 i1="12" i2="1"><s1>VAN SOLINGEN-RISTEA (Rodica)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>WITEK (James)</s1>
</fA11>
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<s2>Los Angeles, CA</s2>
<s3>USA</s3>
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<s3>USA</s3>
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</fA14>
<fA14 i1="03"><s1>North Broward Hospital District</s1>
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<sZ>3 aut.</sZ>
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<fA14 i1="04"><s1>Wohlfeiler, Piperato and Associates LLC</s1>
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<fA14 i1="05"><s1>Therapeutic Concepts</s1>
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<sZ>6 aut.</sZ>
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</fA14>
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<sZ>8 aut.</sZ>
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<sZ>12 aut.</sZ>
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<fC01 i1="01" l="ENG"><s0>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.</s0>
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<s5>09</s5>
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<ET>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</ET>
<AU>TOWNER (William); LALEZARI (Jacob); SENSION (Michael G.); WOHLFEILER (Michael); GATHE (Joseph); APPELBAUM (Jonathan S.); BELLMAN (Paul); GOTTLIEB (Michael S.); RYAN (Robert); NIJS (Steven); HOOGSTOEL (Annemie); VAN SOLINGEN-RISTEA (Rodica); WITEK (James)</AU>
<AF>Kaiser Permanente-Infectious Diseases/Los Angeles, CA/Etats-Unis (1 aut.); Quest Clinical Research/San Francisco, CA/Etats-Unis (2 aut.); North Broward Hospital District/Fort Lauderdale, FL/Etats-Unis (3 aut.); Wohlfeiler, Piperato and Associates LLC/North Miami Beach, FL/Etats-Unis (4 aut.); Therapeutic Concepts/Houston, TX/Etats-Unis (5 aut.); Community Research Initiative of New England/Boston, MA/Etats-Unis (6 aut.); Office of Paul Bellman, MD/New York, NY/Etats-Unis (7 aut.); Synergy Hematology/Oncology/Los Angeles, CA/Etats-Unis (8 aut.); Tibotec, Inc/Titusville, NJ/Etats-Unis (9 aut.); Tibotec BVBA/Mechelen/Belgique (10 aut., 11 aut., 12 aut.); Tibotec Therapeutics/Titusville, NJ/Etats-Unis (13 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Journal of acquired immune deficiency syndromes : (1999); ISSN 1525-4135; Etats-Unis; Da. 2010; Vol. 53; No. 5; Pp. 614-618; Bibl. 8 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
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<SD>Hombre; Eficacia; Ritonavir; Raltegravir; Tratamiento; Estados Unidos; Inhibitor reverse transcriptase; Etravirina; Darunavir; Antiviral</SD>
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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

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

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