Etravirine plasma exposure is associated with virological efficacy in treatment-experienced HIV-positive patients
•Higher etravirine concentrations and weighted genetic inhibitory quotients are associated with virological success.•We propose here two possible targets associated with efficacy: 300ng/mL for etravirine Ctroughs and 276ng/mL for wgIQ.•These data confirm etravirine genetic barrier and they support d...
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| Veröffentlicht in: | Antiviral research 2014-08, Vol.108, p.44-47 |
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| creator | Calcagno, A. Marinaro, L. Nozza, S. Aldieri, C. Carbone, A. Ghisetti, V. Trentalange, A. D’Avolio, A. Castagna, A. Di Perri, G. Bonora, S. |
| description | •Higher etravirine concentrations and weighted genetic inhibitory quotients are associated with virological success.•We propose here two possible targets associated with efficacy: 300ng/mL for etravirine Ctroughs and 276ng/mL for wgIQ.•These data confirm etravirine genetic barrier and they support dose optimization in patients with limited options.
Etravirine is a non-nucleoside reverse transcriptase inhibitor used in combination with other antiretrovirals for the treatment of HIV infection. Given previous conflicting results aim of this study was to investigate whether etravirine plasma exposure was associated with virological outcome.
Adult HIV-positive patients starting etravirine with detectable HIV viral loads were included if highly adherent (276ng/mL/mutation (p=0.02) were associated with virological success; at multivariate Cox proportional analysis etravirine wgIQ |
| doi_str_mv | 10.1016/j.antiviral.2014.05.009 |
| format | Article |
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Etravirine is a non-nucleoside reverse transcriptase inhibitor used in combination with other antiretrovirals for the treatment of HIV infection. Given previous conflicting results aim of this study was to investigate whether etravirine plasma exposure was associated with virological outcome.
Adult HIV-positive patients starting etravirine with detectable HIV viral loads were included if highly adherent (<90% of the doses) and if steady-state plasma concentrations were available (measured through a validated HPLC–PDA method). Virological success was defined as reaching and maintaining viral suppression (HIV RNA <50copies/mL) during follow up.
Fifty-nine (84.7% male) patients were included: baseline CD4+ T-lymphocyte and HIV RNA were 276cells/μL (101–419) and 3.99Log10copies/mL (3.11–4.91), respectively. Darunavir/ritonavir (n=21, 35.6%) and raltegravir plus maraviroc (n=33, 55.9%) were the most common associated antiretrovirals. 240 trough samples were available (3–7 per patient); etravirine trough concentrations (Ctrough) and weighted genotypic inhibitory quotients (wgIQ) were 426ng/mL (266–763) and 408ng/mL/mutation (227–663), respectively. Virological success was observed in 49 patients (83.1%). Genotypic sensitivity of associated drugs (GSS) ⩾2 (p=0.03), etravirine Ctrough >300ng/mL (p=0.02) and etravirine wgIQ >276ng/mL/mutation (p=0.02) were associated with virological success; at multivariate Cox proportional analysis etravirine wgIQ <276ng/mL/mutation (p=0.012) and baseline CD4 <200cell/μL (p=0.043) were independently associated with virological failure.
In a cohort of experienced patients etravirine exposure as well as immune status were associated with virological success; two cut off values (300ng/mL and 276ng/mL) were proposed for etravirine Ctrough and wgIQ and need to be confirmed in prospective studies.</description><identifier>ISSN: 0166-3542</identifier><identifier>EISSN: 1872-9096</identifier><identifier>DOI: 10.1016/j.antiviral.2014.05.009</identifier><identifier>PMID: 24861522</identifier><identifier>CODEN: ARSRDR</identifier><language>eng</language><publisher>Kidlington: Elsevier B.V</publisher><subject>Adult ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Biological and medical sciences ; CD4 Lymphocyte Count ; Etravirine ; Experienced patients ; Female ; HIV - genetics ; HIV - isolation & purification ; HIV Infections - drug therapy ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunopathology ; Infectious diseases ; Inhibitory quotient ; Male ; Medical sciences ; Middle Aged ; Pharmacokinetics ; Pharmacology. Drug treatments ; Plasma - chemistry ; Pyridazines - pharmacokinetics ; Pyridazines - therapeutic use ; Resistance ; Retrospective Studies ; Reverse Transcriptase Inhibitors - pharmacokinetics ; Reverse Transcriptase Inhibitors - therapeutic use ; RNA, Viral - blood ; Treatment Outcome ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Viral Load</subject><ispartof>Antiviral research, 2014-08, Vol.108, p.44-47</ispartof><rights>2014 Elsevier B.V.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2014 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c483t-cf04c4787a590290079c50a5a84aa18ffc28dbeee7d6e1667352149dfdd6fc1e3</citedby><cites>FETCH-LOGICAL-c483t-cf04c4787a590290079c50a5a84aa18ffc28dbeee7d6e1667352149dfdd6fc1e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0166354214001387$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28640529$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24861522$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Calcagno, A.</creatorcontrib><creatorcontrib>Marinaro, L.</creatorcontrib><creatorcontrib>Nozza, S.</creatorcontrib><creatorcontrib>Aldieri, C.</creatorcontrib><creatorcontrib>Carbone, A.</creatorcontrib><creatorcontrib>Ghisetti, V.</creatorcontrib><creatorcontrib>Trentalange, A.</creatorcontrib><creatorcontrib>D’Avolio, A.</creatorcontrib><creatorcontrib>Castagna, A.</creatorcontrib><creatorcontrib>Di Perri, G.</creatorcontrib><creatorcontrib>Bonora, S.</creatorcontrib><title>Etravirine plasma exposure is associated with virological efficacy in treatment-experienced HIV-positive patients</title><title>Antiviral research</title><addtitle>Antiviral Res</addtitle><description>•Higher etravirine concentrations and weighted genetic inhibitory quotients are associated with virological success.•We propose here two possible targets associated with efficacy: 300ng/mL for etravirine Ctroughs and 276ng/mL for wgIQ.•These data confirm etravirine genetic barrier and they support dose optimization in patients with limited options.
Etravirine is a non-nucleoside reverse transcriptase inhibitor used in combination with other antiretrovirals for the treatment of HIV infection. Given previous conflicting results aim of this study was to investigate whether etravirine plasma exposure was associated with virological outcome.
Adult HIV-positive patients starting etravirine with detectable HIV viral loads were included if highly adherent (<90% of the doses) and if steady-state plasma concentrations were available (measured through a validated HPLC–PDA method). Virological success was defined as reaching and maintaining viral suppression (HIV RNA <50copies/mL) during follow up.
Fifty-nine (84.7% male) patients were included: baseline CD4+ T-lymphocyte and HIV RNA were 276cells/μL (101–419) and 3.99Log10copies/mL (3.11–4.91), respectively. Darunavir/ritonavir (n=21, 35.6%) and raltegravir plus maraviroc (n=33, 55.9%) were the most common associated antiretrovirals. 240 trough samples were available (3–7 per patient); etravirine trough concentrations (Ctrough) and weighted genotypic inhibitory quotients (wgIQ) were 426ng/mL (266–763) and 408ng/mL/mutation (227–663), respectively. Virological success was observed in 49 patients (83.1%). Genotypic sensitivity of associated drugs (GSS) ⩾2 (p=0.03), etravirine Ctrough >300ng/mL (p=0.02) and etravirine wgIQ >276ng/mL/mutation (p=0.02) were associated with virological success; at multivariate Cox proportional analysis etravirine wgIQ <276ng/mL/mutation (p=0.012) and baseline CD4 <200cell/μL (p=0.043) were independently associated with virological failure.
In a cohort of experienced patients etravirine exposure as well as immune status were associated with virological success; two cut off values (300ng/mL and 276ng/mL) were proposed for etravirine Ctrough and wgIQ and need to be confirmed in prospective studies.</description><subject>Adult</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiviral agents</subject><subject>Biological and medical sciences</subject><subject>CD4 Lymphocyte Count</subject><subject>Etravirine</subject><subject>Experienced patients</subject><subject>Female</subject><subject>HIV - genetics</subject><subject>HIV - isolation & purification</subject><subject>HIV Infections - drug therapy</subject><subject>Human immunodeficiency virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunodeficiencies</subject><subject>Immunodeficiencies. Immunoglobulinopathies</subject><subject>Immunopathology</subject><subject>Infectious diseases</subject><subject>Inhibitory quotient</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacokinetics</subject><subject>Pharmacology. Drug treatments</subject><subject>Plasma - chemistry</subject><subject>Pyridazines - pharmacokinetics</subject><subject>Pyridazines - therapeutic use</subject><subject>Resistance</subject><subject>Retrospective Studies</subject><subject>Reverse Transcriptase Inhibitors - pharmacokinetics</subject><subject>Reverse Transcriptase Inhibitors - therapeutic use</subject><subject>RNA, Viral - blood</subject><subject>Treatment Outcome</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Viral Load</subject><issn>0166-3542</issn><issn>1872-9096</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkUtvFDEQhC0EIpvAX4C5IHGZoe31Y3yMokAiReICXK2Opw1ezWNjexPy7_FqN-GYU0vWV-XuKsY-cug4cP1l0-Fc4n1MOHYCuOxAdQD2FVvx3ojWgtWv2aqSul0rKU7Yac4bANDG9m_ZiZC95kqIFbu7LAmrT5yp2Y6YJ2zo73bJu0RNzA3mvPiIhYbmIZY_TSWXcfkdPY4NhVCnf2zi3JREWCaaS1vVlCLNvkqurn-11SvWTas7lvpc8jv2JuCY6f1xnrGfXy9_XFy1N9-_XV-c37Re9uvS-gDSS9MbVBaEBTDWK0CFvUTkfQhe9MMtEZlBU73TrJXg0g5hGHTwnNZn7PPBd5uWux3l4qaYPY0jzrTssuNaGGuAW_EyqqSSe15X1BxQn5acEwW3TXHC9Og4uH01buOeq3H7ahwoV6upyg_HT3a3Ew3PuqcuKvDpCGCu-YaEs4_5P9drCUrsjc4PHNX07iMll_0h8JjIFzcs8cVl_gGES7OJ</recordid><startdate>20140801</startdate><enddate>20140801</enddate><creator>Calcagno, A.</creator><creator>Marinaro, L.</creator><creator>Nozza, S.</creator><creator>Aldieri, C.</creator><creator>Carbone, A.</creator><creator>Ghisetti, V.</creator><creator>Trentalange, A.</creator><creator>D’Avolio, A.</creator><creator>Castagna, A.</creator><creator>Di Perri, G.</creator><creator>Bonora, S.</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><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>7X8</scope><scope>7T7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope></search><sort><creationdate>20140801</creationdate><title>Etravirine plasma exposure is associated with virological efficacy in treatment-experienced HIV-positive patients</title><author>Calcagno, A. ; Marinaro, L. ; Nozza, S. ; Aldieri, C. ; Carbone, A. ; Ghisetti, V. ; Trentalange, A. ; D’Avolio, A. ; Castagna, A. ; Di Perri, G. ; Bonora, S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c483t-cf04c4787a590290079c50a5a84aa18ffc28dbeee7d6e1667352149dfdd6fc1e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiviral agents</topic><topic>Biological and medical sciences</topic><topic>CD4 Lymphocyte Count</topic><topic>Etravirine</topic><topic>Experienced patients</topic><topic>Female</topic><topic>HIV - genetics</topic><topic>HIV - isolation & purification</topic><topic>HIV Infections - drug therapy</topic><topic>Human immunodeficiency virus</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immunodeficiencies</topic><topic>Immunodeficiencies. Immunoglobulinopathies</topic><topic>Immunopathology</topic><topic>Infectious diseases</topic><topic>Inhibitory quotient</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacokinetics</topic><topic>Pharmacology. Drug treatments</topic><topic>Plasma - chemistry</topic><topic>Pyridazines - pharmacokinetics</topic><topic>Pyridazines - therapeutic use</topic><topic>Resistance</topic><topic>Retrospective Studies</topic><topic>Reverse Transcriptase Inhibitors - pharmacokinetics</topic><topic>Reverse Transcriptase Inhibitors - therapeutic use</topic><topic>RNA, Viral - blood</topic><topic>Treatment Outcome</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><topic>Viral Load</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Calcagno, A.</creatorcontrib><creatorcontrib>Marinaro, L.</creatorcontrib><creatorcontrib>Nozza, S.</creatorcontrib><creatorcontrib>Aldieri, C.</creatorcontrib><creatorcontrib>Carbone, A.</creatorcontrib><creatorcontrib>Ghisetti, V.</creatorcontrib><creatorcontrib>Trentalange, A.</creatorcontrib><creatorcontrib>D’Avolio, A.</creatorcontrib><creatorcontrib>Castagna, A.</creatorcontrib><creatorcontrib>Di Perri, G.</creatorcontrib><creatorcontrib>Bonora, S.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Antiviral research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Calcagno, A.</au><au>Marinaro, L.</au><au>Nozza, S.</au><au>Aldieri, C.</au><au>Carbone, A.</au><au>Ghisetti, V.</au><au>Trentalange, A.</au><au>D’Avolio, A.</au><au>Castagna, A.</au><au>Di Perri, G.</au><au>Bonora, S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Etravirine plasma exposure is associated with virological efficacy in treatment-experienced HIV-positive patients</atitle><jtitle>Antiviral research</jtitle><addtitle>Antiviral Res</addtitle><date>2014-08-01</date><risdate>2014</risdate><volume>108</volume><spage>44</spage><epage>47</epage><pages>44-47</pages><issn>0166-3542</issn><eissn>1872-9096</eissn><coden>ARSRDR</coden><abstract>•Higher etravirine concentrations and weighted genetic inhibitory quotients are associated with virological success.•We propose here two possible targets associated with efficacy: 300ng/mL for etravirine Ctroughs and 276ng/mL for wgIQ.•These data confirm etravirine genetic barrier and they support dose optimization in patients with limited options.
Etravirine is a non-nucleoside reverse transcriptase inhibitor used in combination with other antiretrovirals for the treatment of HIV infection. Given previous conflicting results aim of this study was to investigate whether etravirine plasma exposure was associated with virological outcome.
Adult HIV-positive patients starting etravirine with detectable HIV viral loads were included if highly adherent (<90% of the doses) and if steady-state plasma concentrations were available (measured through a validated HPLC–PDA method). Virological success was defined as reaching and maintaining viral suppression (HIV RNA <50copies/mL) during follow up.
Fifty-nine (84.7% male) patients were included: baseline CD4+ T-lymphocyte and HIV RNA were 276cells/μL (101–419) and 3.99Log10copies/mL (3.11–4.91), respectively. Darunavir/ritonavir (n=21, 35.6%) and raltegravir plus maraviroc (n=33, 55.9%) were the most common associated antiretrovirals. 240 trough samples were available (3–7 per patient); etravirine trough concentrations (Ctrough) and weighted genotypic inhibitory quotients (wgIQ) were 426ng/mL (266–763) and 408ng/mL/mutation (227–663), respectively. Virological success was observed in 49 patients (83.1%). Genotypic sensitivity of associated drugs (GSS) ⩾2 (p=0.03), etravirine Ctrough >300ng/mL (p=0.02) and etravirine wgIQ >276ng/mL/mutation (p=0.02) were associated with virological success; at multivariate Cox proportional analysis etravirine wgIQ <276ng/mL/mutation (p=0.012) and baseline CD4 <200cell/μL (p=0.043) were independently associated with virological failure.
In a cohort of experienced patients etravirine exposure as well as immune status were associated with virological success; two cut off values (300ng/mL and 276ng/mL) were proposed for etravirine Ctrough and wgIQ and need to be confirmed in prospective studies.</abstract><cop>Kidlington</cop><pub>Elsevier B.V</pub><pmid>24861522</pmid><doi>10.1016/j.antiviral.2014.05.009</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Biological and medical sciences CD4 Lymphocyte Count Etravirine Experienced patients Female HIV - genetics HIV - isolation & purification HIV Infections - drug therapy Human immunodeficiency virus Human viral diseases Humans Immunodeficiencies Immunodeficiencies. Immunoglobulinopathies Immunopathology Infectious diseases Inhibitory quotient Male Medical sciences Middle Aged Pharmacokinetics Pharmacology. Drug treatments Plasma - chemistry Pyridazines - pharmacokinetics Pyridazines - therapeutic use Resistance Retrospective Studies Reverse Transcriptase Inhibitors - pharmacokinetics Reverse Transcriptase Inhibitors - therapeutic use RNA, Viral - blood Treatment Outcome Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Viral Load |
| title | Etravirine plasma exposure is associated with virological efficacy in treatment-experienced HIV-positive patients |
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