Once-daily etravirine/raltegravir (400/800 mg q24h) dual therapy maintains viral suppression over 48 weeks in HIV-infected patients switching from a twice-daily etravirine/raltegravir (200/400 mg q12h) regimen

Abstract Background Etravirine/raltegravir dual therapy has been shown to be highly effective as a twice-daily (q12h) regimen in suppressed HIV-infected patients enrolled in the ANRS-163 study. Objectives As a once-daily (q24h) regimen is easier for daily life, we aimed to evaluate the capacity of e...

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Veröffentlicht in:Journal of antimicrobial chemotherapy 2021-01, Vol.76 (2), p.477-481
Hauptverfasser: Palich, Romain, Allavena, Clotilde, Peytavin, Gilles, Soulie, Cathia, Tubiana, Roland, Weiss, Laurence, Montoya Ferrer, Ana, Duvivier, Claudine, Bouchaud, Olivier, Bottero, Julie, Durand, Aurore, Lê, Minh-Patrick, Marcelin, Anne-Geneviève, Dudoit, Yasmine, Assoumou, Lambert, Katlama, Christine
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container_end_page 481
container_issue 2
container_start_page 477
container_title Journal of antimicrobial chemotherapy
container_volume 76
creator Palich, Romain
Allavena, Clotilde
Peytavin, Gilles
Soulie, Cathia
Tubiana, Roland
Weiss, Laurence
Montoya Ferrer, Ana
Duvivier, Claudine
Bouchaud, Olivier
Bottero, Julie
Durand, Aurore
Lê, Minh-Patrick
Marcelin, Anne-Geneviève
Dudoit, Yasmine
Assoumou, Lambert
Katlama, Christine
description Abstract Background Etravirine/raltegravir dual therapy has been shown to be highly effective as a twice-daily (q12h) regimen in suppressed HIV-infected patients enrolled in the ANRS-163 study. Objectives As a once-daily (q24h) regimen is easier for daily life, we aimed to evaluate the capacity of etravirine/raltegravir (400/800 mg) q24h to maintain viral suppression in patients on etravirine/raltegravir q12h. Methods Patients on a suppressive etravirine/raltegravir q12h regimen for at least 96 weeks were switched to etravirine/raltegravir q24h in this prospective, multicentre, open-label, single-arm study. Primary outcome was the rate of virological failure (VF: confirmed pVL >50 copies/mL, single pVL >400 copies/mL or single pVL >50 copies/mL with ART change) at Week 48 (W48). Secondary outcomes included treatment strategy success rate (no VF and no treatment discontinuation), regimen tolerability, plasma drug concentrations and resistance profile in the case of VF. Results A total of 111 patients were enrolled, with a median (IQR) age of 57 years (52–62), CD4 count of 710 cells/mm3 (501–919) and viral suppression for 7.9 years (5.9–10.7). Two patients experienced viral rebound at W24 and W48, leading to a VF rate of 2.0% (95% CI 0.5–7.8) at W48, associated with INSTI resistance in one case. Both had past NNRTI mutations. Ten patients discontinued treatment for adverse events (n = 2), investigator or patient decisions (n = 3), lost to follow-up (n = 3), death (n = 1) or pregnancy (n = 1). Overall, the strategy success rate was 89% (95% CI 81.5–93.6) at W48. In a subgroup of 64 patients, median (IQR) plasma C24h concentrations were 401 ng/mL (280–603) for etravirine and 62 ng/mL (31–140) for raltegravir. Conclusions Switching patients virally suppressed on etravirine/raltegravir q12h to the same regimen but given q24h was highly effective in maintaining virological suppression in HIV-infected patients.
doi_str_mv 10.1093/jac/dkaa423
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Objectives As a once-daily (q24h) regimen is easier for daily life, we aimed to evaluate the capacity of etravirine/raltegravir (400/800 mg) q24h to maintain viral suppression in patients on etravirine/raltegravir q12h. Methods Patients on a suppressive etravirine/raltegravir q12h regimen for at least 96 weeks were switched to etravirine/raltegravir q24h in this prospective, multicentre, open-label, single-arm study. Primary outcome was the rate of virological failure (VF: confirmed pVL &gt;50 copies/mL, single pVL &gt;400 copies/mL or single pVL &gt;50 copies/mL with ART change) at Week 48 (W48). Secondary outcomes included treatment strategy success rate (no VF and no treatment discontinuation), regimen tolerability, plasma drug concentrations and resistance profile in the case of VF. Results A total of 111 patients were enrolled, with a median (IQR) age of 57 years (52–62), CD4 count of 710 cells/mm3 (501–919) and viral suppression for 7.9 years (5.9–10.7). Two patients experienced viral rebound at W24 and W48, leading to a VF rate of 2.0% (95% CI 0.5–7.8) at W48, associated with INSTI resistance in one case. Both had past NNRTI mutations. Ten patients discontinued treatment for adverse events (n = 2), investigator or patient decisions (n = 3), lost to follow-up (n = 3), death (n = 1) or pregnancy (n = 1). Overall, the strategy success rate was 89% (95% CI 81.5–93.6) at W48. In a subgroup of 64 patients, median (IQR) plasma C24h concentrations were 401 ng/mL (280–603) for etravirine and 62 ng/mL (31–140) for raltegravir. Conclusions Switching patients virally suppressed on etravirine/raltegravir q12h to the same regimen but given q24h was highly effective in maintaining virological suppression in HIV-infected patients.</description><identifier>ISSN: 0305-7453</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dkaa423</identifier><identifier>PMID: 33099638</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Anti-HIV Agents - therapeutic use ; HIV Infections - drug therapy ; HIV-1 ; Human health and pathology ; Humans ; Infectious diseases ; Life Sciences ; Middle Aged ; Nitriles ; Prospective Studies ; Pyrimidines ; Raltegravir Potassium - therapeutic use ; Treatment Outcome ; Viral Load</subject><ispartof>Journal of antimicrobial chemotherapy, 2021-01, Vol.76 (2), p.477-481</ispartof><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please email: journals.permissions@oup.com. 2021</rights><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please email: journals.permissions@oup.com.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c349t-10a87baed0d9c0cc8a92a373830a6fc1d62e54aad95da79cadc5d52c6ac508453</cites><orcidid>0000-0002-4670-8288 ; 0000-0002-4359-537X ; 0000-0003-1010-1270 ; 0000-0001-6949-3630 ; 0000-0003-0047-0101</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33099638$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.sorbonne-universite.fr/hal-03177872$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Palich, Romain</creatorcontrib><creatorcontrib>Allavena, Clotilde</creatorcontrib><creatorcontrib>Peytavin, Gilles</creatorcontrib><creatorcontrib>Soulie, Cathia</creatorcontrib><creatorcontrib>Tubiana, Roland</creatorcontrib><creatorcontrib>Weiss, Laurence</creatorcontrib><creatorcontrib>Montoya Ferrer, Ana</creatorcontrib><creatorcontrib>Duvivier, Claudine</creatorcontrib><creatorcontrib>Bouchaud, Olivier</creatorcontrib><creatorcontrib>Bottero, Julie</creatorcontrib><creatorcontrib>Durand, Aurore</creatorcontrib><creatorcontrib>Lê, Minh-Patrick</creatorcontrib><creatorcontrib>Marcelin, Anne-Geneviève</creatorcontrib><creatorcontrib>Dudoit, Yasmine</creatorcontrib><creatorcontrib>Assoumou, Lambert</creatorcontrib><creatorcontrib>Katlama, Christine</creatorcontrib><creatorcontrib>ETRAL QD study group</creatorcontrib><creatorcontrib>the ETRAL QD study group</creatorcontrib><title>Once-daily etravirine/raltegravir (400/800 mg q24h) dual therapy maintains viral suppression over 48 weeks in HIV-infected patients switching from a twice-daily etravirine/raltegravir (200/400 mg q12h) regimen</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>Abstract Background Etravirine/raltegravir dual therapy has been shown to be highly effective as a twice-daily (q12h) regimen in suppressed HIV-infected patients enrolled in the ANRS-163 study. Objectives As a once-daily (q24h) regimen is easier for daily life, we aimed to evaluate the capacity of etravirine/raltegravir (400/800 mg) q24h to maintain viral suppression in patients on etravirine/raltegravir q12h. Methods Patients on a suppressive etravirine/raltegravir q12h regimen for at least 96 weeks were switched to etravirine/raltegravir q24h in this prospective, multicentre, open-label, single-arm study. Primary outcome was the rate of virological failure (VF: confirmed pVL &gt;50 copies/mL, single pVL &gt;400 copies/mL or single pVL &gt;50 copies/mL with ART change) at Week 48 (W48). Secondary outcomes included treatment strategy success rate (no VF and no treatment discontinuation), regimen tolerability, plasma drug concentrations and resistance profile in the case of VF. Results A total of 111 patients were enrolled, with a median (IQR) age of 57 years (52–62), CD4 count of 710 cells/mm3 (501–919) and viral suppression for 7.9 years (5.9–10.7). Two patients experienced viral rebound at W24 and W48, leading to a VF rate of 2.0% (95% CI 0.5–7.8) at W48, associated with INSTI resistance in one case. Both had past NNRTI mutations. Ten patients discontinued treatment for adverse events (n = 2), investigator or patient decisions (n = 3), lost to follow-up (n = 3), death (n = 1) or pregnancy (n = 1). Overall, the strategy success rate was 89% (95% CI 81.5–93.6) at W48. In a subgroup of 64 patients, median (IQR) plasma C24h concentrations were 401 ng/mL (280–603) for etravirine and 62 ng/mL (31–140) for raltegravir. Conclusions Switching patients virally suppressed on etravirine/raltegravir q12h to the same regimen but given q24h was highly effective in maintaining virological suppression in HIV-infected patients.</description><subject>Anti-HIV Agents - therapeutic use</subject><subject>HIV Infections - drug therapy</subject><subject>HIV-1</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Life Sciences</subject><subject>Middle Aged</subject><subject>Nitriles</subject><subject>Prospective Studies</subject><subject>Pyrimidines</subject><subject>Raltegravir Potassium - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Viral Load</subject><issn>0305-7453</issn><issn>1460-2091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU9rGzEQxUVpaZy0p96LTqWhbDxaaXe1xxCaOmDIJel1mUiztpL9V0m28cfsN6oSuzm2h2GYx2-GxzzGPgm4EFDL-SOauX1CVLl8w2ZClZDlUIu3bAYSiqxShTxhpyE8AkBZlPo9O5ES6rqUesZ-3w6GMouu23OKHrfOu4HmHrtIq5eRf1UAcw3A-xX_lav1Obcb7Hhck8dpz3t0Q0wVeIKTHjbT5CkENw583JLnSvMd0VPgbuCLm5-ZG1oykSyfMDoaYuBh56JZu2HFWz_2HHncuf-6ypMrdXQl8uTK08r1NHxg71rsAn089jN2f_397mqRLW9_3FxdLjMjVR0zAairByQLtjZgjMY6R1lJLQHL1ghb5lQoRFsXFqvaoDWFLXJToilAp5-esfPD3TV2zeRdj37fjOiaxeWyedZAiqrSVb4Vif12YI0fQ_DUvi4IaJ5DbFKIzTHERH8-0NPmoSf7yv5NLQFfDsC4mf556Q9sQ6dW</recordid><startdate>20210119</startdate><enddate>20210119</enddate><creator>Palich, Romain</creator><creator>Allavena, Clotilde</creator><creator>Peytavin, Gilles</creator><creator>Soulie, Cathia</creator><creator>Tubiana, Roland</creator><creator>Weiss, Laurence</creator><creator>Montoya Ferrer, Ana</creator><creator>Duvivier, Claudine</creator><creator>Bouchaud, Olivier</creator><creator>Bottero, Julie</creator><creator>Durand, Aurore</creator><creator>Lê, Minh-Patrick</creator><creator>Marcelin, Anne-Geneviève</creator><creator>Dudoit, Yasmine</creator><creator>Assoumou, Lambert</creator><creator>Katlama, Christine</creator><general>Oxford University Press</general><general>Oxford University Press (OUP)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>1XC</scope><scope>VOOES</scope><orcidid>https://orcid.org/0000-0002-4670-8288</orcidid><orcidid>https://orcid.org/0000-0002-4359-537X</orcidid><orcidid>https://orcid.org/0000-0003-1010-1270</orcidid><orcidid>https://orcid.org/0000-0001-6949-3630</orcidid><orcidid>https://orcid.org/0000-0003-0047-0101</orcidid></search><sort><creationdate>20210119</creationdate><title>Once-daily etravirine/raltegravir (400/800 mg q24h) dual therapy maintains viral suppression over 48 weeks in HIV-infected patients switching from a twice-daily etravirine/raltegravir (200/400 mg q12h) regimen</title><author>Palich, Romain ; Allavena, Clotilde ; Peytavin, Gilles ; Soulie, Cathia ; Tubiana, Roland ; Weiss, Laurence ; Montoya Ferrer, Ana ; Duvivier, Claudine ; Bouchaud, Olivier ; Bottero, Julie ; Durand, Aurore ; Lê, Minh-Patrick ; Marcelin, Anne-Geneviève ; Dudoit, Yasmine ; Assoumou, Lambert ; Katlama, Christine</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c349t-10a87baed0d9c0cc8a92a373830a6fc1d62e54aad95da79cadc5d52c6ac508453</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Anti-HIV Agents - therapeutic use</topic><topic>HIV Infections - drug therapy</topic><topic>HIV-1</topic><topic>Human health and pathology</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Life Sciences</topic><topic>Middle Aged</topic><topic>Nitriles</topic><topic>Prospective Studies</topic><topic>Pyrimidines</topic><topic>Raltegravir Potassium - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Viral Load</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Palich, Romain</creatorcontrib><creatorcontrib>Allavena, Clotilde</creatorcontrib><creatorcontrib>Peytavin, Gilles</creatorcontrib><creatorcontrib>Soulie, Cathia</creatorcontrib><creatorcontrib>Tubiana, Roland</creatorcontrib><creatorcontrib>Weiss, Laurence</creatorcontrib><creatorcontrib>Montoya Ferrer, Ana</creatorcontrib><creatorcontrib>Duvivier, Claudine</creatorcontrib><creatorcontrib>Bouchaud, Olivier</creatorcontrib><creatorcontrib>Bottero, Julie</creatorcontrib><creatorcontrib>Durand, Aurore</creatorcontrib><creatorcontrib>Lê, Minh-Patrick</creatorcontrib><creatorcontrib>Marcelin, Anne-Geneviève</creatorcontrib><creatorcontrib>Dudoit, Yasmine</creatorcontrib><creatorcontrib>Assoumou, Lambert</creatorcontrib><creatorcontrib>Katlama, Christine</creatorcontrib><creatorcontrib>ETRAL QD study group</creatorcontrib><creatorcontrib>the ETRAL QD study group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><jtitle>Journal of antimicrobial chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Palich, Romain</au><au>Allavena, Clotilde</au><au>Peytavin, Gilles</au><au>Soulie, Cathia</au><au>Tubiana, Roland</au><au>Weiss, Laurence</au><au>Montoya Ferrer, Ana</au><au>Duvivier, Claudine</au><au>Bouchaud, Olivier</au><au>Bottero, Julie</au><au>Durand, Aurore</au><au>Lê, Minh-Patrick</au><au>Marcelin, Anne-Geneviève</au><au>Dudoit, Yasmine</au><au>Assoumou, Lambert</au><au>Katlama, Christine</au><aucorp>ETRAL QD study group</aucorp><aucorp>the ETRAL QD study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Once-daily etravirine/raltegravir (400/800 mg q24h) dual therapy maintains viral suppression over 48 weeks in HIV-infected patients switching from a twice-daily etravirine/raltegravir (200/400 mg q12h) regimen</atitle><jtitle>Journal of antimicrobial chemotherapy</jtitle><addtitle>J Antimicrob Chemother</addtitle><date>2021-01-19</date><risdate>2021</risdate><volume>76</volume><issue>2</issue><spage>477</spage><epage>481</epage><pages>477-481</pages><issn>0305-7453</issn><eissn>1460-2091</eissn><abstract>Abstract Background Etravirine/raltegravir dual therapy has been shown to be highly effective as a twice-daily (q12h) regimen in suppressed HIV-infected patients enrolled in the ANRS-163 study. Objectives As a once-daily (q24h) regimen is easier for daily life, we aimed to evaluate the capacity of etravirine/raltegravir (400/800 mg) q24h to maintain viral suppression in patients on etravirine/raltegravir q12h. Methods Patients on a suppressive etravirine/raltegravir q12h regimen for at least 96 weeks were switched to etravirine/raltegravir q24h in this prospective, multicentre, open-label, single-arm study. Primary outcome was the rate of virological failure (VF: confirmed pVL &gt;50 copies/mL, single pVL &gt;400 copies/mL or single pVL &gt;50 copies/mL with ART change) at Week 48 (W48). Secondary outcomes included treatment strategy success rate (no VF and no treatment discontinuation), regimen tolerability, plasma drug concentrations and resistance profile in the case of VF. Results A total of 111 patients were enrolled, with a median (IQR) age of 57 years (52–62), CD4 count of 710 cells/mm3 (501–919) and viral suppression for 7.9 years (5.9–10.7). Two patients experienced viral rebound at W24 and W48, leading to a VF rate of 2.0% (95% CI 0.5–7.8) at W48, associated with INSTI resistance in one case. Both had past NNRTI mutations. Ten patients discontinued treatment for adverse events (n = 2), investigator or patient decisions (n = 3), lost to follow-up (n = 3), death (n = 1) or pregnancy (n = 1). Overall, the strategy success rate was 89% (95% CI 81.5–93.6) at W48. In a subgroup of 64 patients, median (IQR) plasma C24h concentrations were 401 ng/mL (280–603) for etravirine and 62 ng/mL (31–140) for raltegravir. Conclusions Switching patients virally suppressed on etravirine/raltegravir q12h to the same regimen but given q24h was highly effective in maintaining virological suppression in HIV-infected patients.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>33099638</pmid><doi>10.1093/jac/dkaa423</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0002-4670-8288</orcidid><orcidid>https://orcid.org/0000-0002-4359-537X</orcidid><orcidid>https://orcid.org/0000-0003-1010-1270</orcidid><orcidid>https://orcid.org/0000-0001-6949-3630</orcidid><orcidid>https://orcid.org/0000-0003-0047-0101</orcidid><oa>free_for_read</oa></addata></record>
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subjects Anti-HIV Agents - therapeutic use
HIV Infections - drug therapy
HIV-1
Human health and pathology
Humans
Infectious diseases
Life Sciences
Middle Aged
Nitriles
Prospective Studies
Pyrimidines
Raltegravir Potassium - therapeutic use
Treatment Outcome
Viral Load
title Once-daily etravirine/raltegravir (400/800 mg q24h) dual therapy maintains viral suppression over 48 weeks in HIV-infected patients switching from a twice-daily etravirine/raltegravir (200/400 mg q12h) regimen
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