Etravirine Has No Effect on QT and Corrected QT Interval in HIV-Negative Volunteers
Background: Etravirine (TMC125), a next-generation nonnucleoside reverse transcriptase inhibitor, has shown antiviral efficacy in 2 large Phase 3 trials. In vitro and in vivo studies have shown that etravirine is not associated with proarrhythmic potential. Electrocardiograms (ECGs) from healthy and...
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| Veröffentlicht in: | The Annals of pharmacotherapy 2008-06, Vol.42 (6), p.757-765 |
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| creator | Peeters, Monika Janssen, Katrien Kakuda, Thomas N Scholler-Gyure, Monika Lachaert, Ruth Hoetelmans, Richard MW Woodfall, Brian De Smedt, Goedele |
| description | Background:
Etravirine (TMC125), a next-generation nonnucleoside reverse transcriptase inhibitor, has shown antiviral efficacy in 2 large Phase 3 trials. In vitro and in vivo studies have shown that etravirine is not associated with proarrhythmic potential. Electrocardiograms (ECGs) from healthy and HIV 1–infected volunteers showed no clinically relevant changes.
Objective:
To evaluate the effect of 2 etravirine dosing regimens on QT/corrected QT interval (QTc) in HIV-negative volunteers and assess pharmacokinetic and additional safety parameters.
Methods:
A double-blind, double-dummy, randomized, placebo- and active-controlled, 4-period crossover trial was conducted in 41 HIV-negative volunteers. Participants received 4 regimens: etravirine 200 mg twice daily, etravirine 400 mg once daily, moxifloxacin 400 mg once daily (positive control), and placebo in separate 8-day sessions, with each followed by a washout period of 14 or more days. On days -1, 1, and 8 of each session, ECGs were recorded at 11 time points over 12 hours. Pharmacokinetic profiles of etravirine regimens were evaluated and safety was assessed.
Results:
Thirty-seven subjects completed the study. For etravirine, the upper limit of the 90% CIs of mean time-matched differences in QTc determined using Fridericia's formula (QTcF) was below 10 msec at all time points, the threshold for prolonged QT as defined by regulatory guidelines. The maximum mean (90% CI) difference of time-matched changes in QTcF versus placebo on day 1 was +0.1 msec (–2.6 to 2.9), -0.2 msec (-2.6 to 2.1), and +10.1 msec (7.3 to 12.8) for etravirine 200 mg twice daily, etravirine 400 mg once daily, and moxifloxacin, respectively. On day 8, these values were +0.6 msec (-2.1 to 3.3), -1.0 msec (-4.4 to 2.5), and +10.3 msec (6.8 to 13.9), respectively. Etravirine produced no clinically significant changes in other ECG parameters. No significant differences between males and females were observed. Both etravirine regimens had similar pharmacokinetic exposure and safety profiles.
Conclusions:
Etravirine does not prolong the QTc interval. No clinically relevant ECG changes were observed in HIV-negative volunteers. Short-term dosing of etravirine in HIV-negative volunteers was generally safe and well tolerated. |
| doi_str_mv | 10.1345/aph.1K681 |
| format | Article |
| fullrecord | <record><control><sourceid>sage_cross</sourceid><recordid>TN_cdi_crossref_primary_10_1345_aph_1K681</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1345_aph.1K681</sage_id><sourcerecordid>10.1345_aph.1K681</sourcerecordid><originalsourceid>FETCH-LOGICAL-c374t-20877ddcd30237d29b57ebe45f294998b2774188ec9b529869e532d26046b5e33</originalsourceid><addsrcrecordid>eNptkE9PwkAQxTdGI4ge_AJmL5p4KO7f7vZoCArRYIzIdbNtp1BSWrJbIH57FyF68TSTeb-8l3kIXVPSp1zIB7te9OlLrOkJ6lIpWBQzRU7DTmISEaZJB114vySEJJQl56hDtRBSEdlFH8PW2W3pyhrwyHo8afCwKCBrcVPj9ym2dY4HjXPhAvn-MK5bcFtb4bLGo_EsmsDctuUW8KypNkED5y_RWWErD1fH2UOfT8PpYBS9vj2PB4-vUcaVaCNGtFJ5nuWcMK5ylqRSQQpCFiwRSaJTppSgWkMWFJboOAHJWc5iIuJUAuc9dH_wzVzjvYPCrF25su7LUGL2xZhQjPkpJrA3B3a9SVeQ_5HHJgJwewSsz2xVOFtnpf_lGOGKax4H7u7AeTsHs2w2rg4__pt4NFyU88WudGD8ylZVyKdmt9sJZmKjpOLf6XKCUA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Etravirine Has No Effect on QT and Corrected QT Interval in HIV-Negative Volunteers</title><source>MEDLINE</source><source>SAGE Complete A-Z List</source><creator>Peeters, Monika ; Janssen, Katrien ; Kakuda, Thomas N ; Scholler-Gyure, Monika ; Lachaert, Ruth ; Hoetelmans, Richard MW ; Woodfall, Brian ; De Smedt, Goedele</creator><creatorcontrib>Peeters, Monika ; Janssen, Katrien ; Kakuda, Thomas N ; Scholler-Gyure, Monika ; Lachaert, Ruth ; Hoetelmans, Richard MW ; Woodfall, Brian ; De Smedt, Goedele</creatorcontrib><description>Background:
Etravirine (TMC125), a next-generation nonnucleoside reverse transcriptase inhibitor, has shown antiviral efficacy in 2 large Phase 3 trials. In vitro and in vivo studies have shown that etravirine is not associated with proarrhythmic potential. Electrocardiograms (ECGs) from healthy and HIV 1–infected volunteers showed no clinically relevant changes.
Objective:
To evaluate the effect of 2 etravirine dosing regimens on QT/corrected QT interval (QTc) in HIV-negative volunteers and assess pharmacokinetic and additional safety parameters.
Methods:
A double-blind, double-dummy, randomized, placebo- and active-controlled, 4-period crossover trial was conducted in 41 HIV-negative volunteers. Participants received 4 regimens: etravirine 200 mg twice daily, etravirine 400 mg once daily, moxifloxacin 400 mg once daily (positive control), and placebo in separate 8-day sessions, with each followed by a washout period of 14 or more days. On days -1, 1, and 8 of each session, ECGs were recorded at 11 time points over 12 hours. Pharmacokinetic profiles of etravirine regimens were evaluated and safety was assessed.
Results:
Thirty-seven subjects completed the study. For etravirine, the upper limit of the 90% CIs of mean time-matched differences in QTc determined using Fridericia's formula (QTcF) was below 10 msec at all time points, the threshold for prolonged QT as defined by regulatory guidelines. The maximum mean (90% CI) difference of time-matched changes in QTcF versus placebo on day 1 was +0.1 msec (–2.6 to 2.9), -0.2 msec (-2.6 to 2.1), and +10.1 msec (7.3 to 12.8) for etravirine 200 mg twice daily, etravirine 400 mg once daily, and moxifloxacin, respectively. On day 8, these values were +0.6 msec (-2.1 to 3.3), -1.0 msec (-4.4 to 2.5), and +10.3 msec (6.8 to 13.9), respectively. Etravirine produced no clinically significant changes in other ECG parameters. No significant differences between males and females were observed. Both etravirine regimens had similar pharmacokinetic exposure and safety profiles.
Conclusions:
Etravirine does not prolong the QTc interval. No clinically relevant ECG changes were observed in HIV-negative volunteers. Short-term dosing of etravirine in HIV-negative volunteers was generally safe and well tolerated.</description><identifier>ISSN: 1060-0280</identifier><identifier>EISSN: 1542-6270</identifier><identifier>DOI: 10.1345/aph.1K681</identifier><identifier>PMID: 18445705</identifier><identifier>CODEN: APHRER</identifier><language>eng</language><publisher>Los Angeles, CA: Harvey Whitney Books</publisher><subject>Adolescent ; Adult ; Anti-HIV Agents - administration & dosage ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - pharmacokinetics ; Anti-Infective Agents - adverse effects ; Aza Compounds - adverse effects ; Biological and medical sciences ; Confidence Intervals ; Cross-Over Studies ; Dose-Response Relationship, Drug ; Double-Blind Method ; Electrocardiography ; Female ; Fluoroquinolones ; Follow-Up Studies ; Human viral diseases ; Humans ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunopathology ; Infectious diseases ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Pyridazines - administration & dosage ; Pyridazines - adverse effects ; Pyridazines - pharmacokinetics ; Quinolines - adverse effects ; Sex Factors ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids</subject><ispartof>The Annals of pharmacotherapy, 2008-06, Vol.42 (6), p.757-765</ispartof><rights>Copyright © 2008 Harvey Whitney Books Company</rights><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c374t-20877ddcd30237d29b57ebe45f294998b2774188ec9b529869e532d26046b5e33</citedby><cites>FETCH-LOGICAL-c374t-20877ddcd30237d29b57ebe45f294998b2774188ec9b529869e532d26046b5e33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1345/aph.1K681$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1345/aph.1K681$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,780,784,21819,27924,27925,43621,43622</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20373836$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18445705$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Peeters, Monika</creatorcontrib><creatorcontrib>Janssen, Katrien</creatorcontrib><creatorcontrib>Kakuda, Thomas N</creatorcontrib><creatorcontrib>Scholler-Gyure, Monika</creatorcontrib><creatorcontrib>Lachaert, Ruth</creatorcontrib><creatorcontrib>Hoetelmans, Richard MW</creatorcontrib><creatorcontrib>Woodfall, Brian</creatorcontrib><creatorcontrib>De Smedt, Goedele</creatorcontrib><title>Etravirine Has No Effect on QT and Corrected QT Interval in HIV-Negative Volunteers</title><title>The Annals of pharmacotherapy</title><addtitle>Ann Pharmacother</addtitle><description>Background:
Etravirine (TMC125), a next-generation nonnucleoside reverse transcriptase inhibitor, has shown antiviral efficacy in 2 large Phase 3 trials. In vitro and in vivo studies have shown that etravirine is not associated with proarrhythmic potential. Electrocardiograms (ECGs) from healthy and HIV 1–infected volunteers showed no clinically relevant changes.
Objective:
To evaluate the effect of 2 etravirine dosing regimens on QT/corrected QT interval (QTc) in HIV-negative volunteers and assess pharmacokinetic and additional safety parameters.
Methods:
A double-blind, double-dummy, randomized, placebo- and active-controlled, 4-period crossover trial was conducted in 41 HIV-negative volunteers. Participants received 4 regimens: etravirine 200 mg twice daily, etravirine 400 mg once daily, moxifloxacin 400 mg once daily (positive control), and placebo in separate 8-day sessions, with each followed by a washout period of 14 or more days. On days -1, 1, and 8 of each session, ECGs were recorded at 11 time points over 12 hours. Pharmacokinetic profiles of etravirine regimens were evaluated and safety was assessed.
Results:
Thirty-seven subjects completed the study. For etravirine, the upper limit of the 90% CIs of mean time-matched differences in QTc determined using Fridericia's formula (QTcF) was below 10 msec at all time points, the threshold for prolonged QT as defined by regulatory guidelines. The maximum mean (90% CI) difference of time-matched changes in QTcF versus placebo on day 1 was +0.1 msec (–2.6 to 2.9), -0.2 msec (-2.6 to 2.1), and +10.1 msec (7.3 to 12.8) for etravirine 200 mg twice daily, etravirine 400 mg once daily, and moxifloxacin, respectively. On day 8, these values were +0.6 msec (-2.1 to 3.3), -1.0 msec (-4.4 to 2.5), and +10.3 msec (6.8 to 13.9), respectively. Etravirine produced no clinically significant changes in other ECG parameters. No significant differences between males and females were observed. Both etravirine regimens had similar pharmacokinetic exposure and safety profiles.
Conclusions:
Etravirine does not prolong the QTc interval. No clinically relevant ECG changes were observed in HIV-negative volunteers. Short-term dosing of etravirine in HIV-negative volunteers was generally safe and well tolerated.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Anti-HIV Agents - administration & dosage</subject><subject>Anti-HIV Agents - adverse effects</subject><subject>Anti-HIV Agents - pharmacokinetics</subject><subject>Anti-Infective Agents - adverse effects</subject><subject>Aza Compounds - adverse effects</subject><subject>Biological and medical sciences</subject><subject>Confidence Intervals</subject><subject>Cross-Over Studies</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Electrocardiography</subject><subject>Female</subject><subject>Fluoroquinolones</subject><subject>Follow-Up Studies</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunodeficiencies</subject><subject>Immunodeficiencies. Immunoglobulinopathies</subject><subject>Immunopathology</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Pyridazines - administration & dosage</subject><subject>Pyridazines - adverse effects</subject><subject>Pyridazines - pharmacokinetics</subject><subject>Quinolines - adverse effects</subject><subject>Sex Factors</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><issn>1060-0280</issn><issn>1542-6270</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptkE9PwkAQxTdGI4ge_AJmL5p4KO7f7vZoCArRYIzIdbNtp1BSWrJbIH57FyF68TSTeb-8l3kIXVPSp1zIB7te9OlLrOkJ6lIpWBQzRU7DTmISEaZJB114vySEJJQl56hDtRBSEdlFH8PW2W3pyhrwyHo8afCwKCBrcVPj9ym2dY4HjXPhAvn-MK5bcFtb4bLGo_EsmsDctuUW8KypNkED5y_RWWErD1fH2UOfT8PpYBS9vj2PB4-vUcaVaCNGtFJ5nuWcMK5ylqRSQQpCFiwRSaJTppSgWkMWFJboOAHJWc5iIuJUAuc9dH_wzVzjvYPCrF25su7LUGL2xZhQjPkpJrA3B3a9SVeQ_5HHJgJwewSsz2xVOFtnpf_lGOGKax4H7u7AeTsHs2w2rg4__pt4NFyU88WudGD8ylZVyKdmt9sJZmKjpOLf6XKCUA</recordid><startdate>20080601</startdate><enddate>20080601</enddate><creator>Peeters, Monika</creator><creator>Janssen, Katrien</creator><creator>Kakuda, Thomas N</creator><creator>Scholler-Gyure, Monika</creator><creator>Lachaert, Ruth</creator><creator>Hoetelmans, Richard MW</creator><creator>Woodfall, Brian</creator><creator>De Smedt, Goedele</creator><general>Harvey Whitney Books</general><general>SAGE Publications</general><general>Whitney</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></search><sort><creationdate>20080601</creationdate><title>Etravirine Has No Effect on QT and Corrected QT Interval in HIV-Negative Volunteers</title><author>Peeters, Monika ; Janssen, Katrien ; Kakuda, Thomas N ; Scholler-Gyure, Monika ; Lachaert, Ruth ; Hoetelmans, Richard MW ; Woodfall, Brian ; De Smedt, Goedele</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c374t-20877ddcd30237d29b57ebe45f294998b2774188ec9b529869e532d26046b5e33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Anti-HIV Agents - administration & dosage</topic><topic>Anti-HIV Agents - adverse effects</topic><topic>Anti-HIV Agents - pharmacokinetics</topic><topic>Anti-Infective Agents - adverse effects</topic><topic>Aza Compounds - adverse effects</topic><topic>Biological and medical sciences</topic><topic>Confidence Intervals</topic><topic>Cross-Over Studies</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Electrocardiography</topic><topic>Female</topic><topic>Fluoroquinolones</topic><topic>Follow-Up Studies</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immunodeficiencies</topic><topic>Immunodeficiencies. Immunoglobulinopathies</topic><topic>Immunopathology</topic><topic>Infectious diseases</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Pyridazines - administration & dosage</topic><topic>Pyridazines - adverse effects</topic><topic>Pyridazines - pharmacokinetics</topic><topic>Quinolines - adverse effects</topic><topic>Sex Factors</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Peeters, Monika</creatorcontrib><creatorcontrib>Janssen, Katrien</creatorcontrib><creatorcontrib>Kakuda, Thomas N</creatorcontrib><creatorcontrib>Scholler-Gyure, Monika</creatorcontrib><creatorcontrib>Lachaert, Ruth</creatorcontrib><creatorcontrib>Hoetelmans, Richard MW</creatorcontrib><creatorcontrib>Woodfall, Brian</creatorcontrib><creatorcontrib>De Smedt, Goedele</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><jtitle>The Annals of pharmacotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Peeters, Monika</au><au>Janssen, Katrien</au><au>Kakuda, Thomas N</au><au>Scholler-Gyure, Monika</au><au>Lachaert, Ruth</au><au>Hoetelmans, Richard MW</au><au>Woodfall, Brian</au><au>De Smedt, Goedele</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Etravirine Has No Effect on QT and Corrected QT Interval in HIV-Negative Volunteers</atitle><jtitle>The Annals of pharmacotherapy</jtitle><addtitle>Ann Pharmacother</addtitle><date>2008-06-01</date><risdate>2008</risdate><volume>42</volume><issue>6</issue><spage>757</spage><epage>765</epage><pages>757-765</pages><issn>1060-0280</issn><eissn>1542-6270</eissn><coden>APHRER</coden><abstract>Background:
Etravirine (TMC125), a next-generation nonnucleoside reverse transcriptase inhibitor, has shown antiviral efficacy in 2 large Phase 3 trials. In vitro and in vivo studies have shown that etravirine is not associated with proarrhythmic potential. Electrocardiograms (ECGs) from healthy and HIV 1–infected volunteers showed no clinically relevant changes.
Objective:
To evaluate the effect of 2 etravirine dosing regimens on QT/corrected QT interval (QTc) in HIV-negative volunteers and assess pharmacokinetic and additional safety parameters.
Methods:
A double-blind, double-dummy, randomized, placebo- and active-controlled, 4-period crossover trial was conducted in 41 HIV-negative volunteers. Participants received 4 regimens: etravirine 200 mg twice daily, etravirine 400 mg once daily, moxifloxacin 400 mg once daily (positive control), and placebo in separate 8-day sessions, with each followed by a washout period of 14 or more days. On days -1, 1, and 8 of each session, ECGs were recorded at 11 time points over 12 hours. Pharmacokinetic profiles of etravirine regimens were evaluated and safety was assessed.
Results:
Thirty-seven subjects completed the study. For etravirine, the upper limit of the 90% CIs of mean time-matched differences in QTc determined using Fridericia's formula (QTcF) was below 10 msec at all time points, the threshold for prolonged QT as defined by regulatory guidelines. The maximum mean (90% CI) difference of time-matched changes in QTcF versus placebo on day 1 was +0.1 msec (–2.6 to 2.9), -0.2 msec (-2.6 to 2.1), and +10.1 msec (7.3 to 12.8) for etravirine 200 mg twice daily, etravirine 400 mg once daily, and moxifloxacin, respectively. On day 8, these values were +0.6 msec (-2.1 to 3.3), -1.0 msec (-4.4 to 2.5), and +10.3 msec (6.8 to 13.9), respectively. Etravirine produced no clinically significant changes in other ECG parameters. No significant differences between males and females were observed. Both etravirine regimens had similar pharmacokinetic exposure and safety profiles.
Conclusions:
Etravirine does not prolong the QTc interval. No clinically relevant ECG changes were observed in HIV-negative volunteers. Short-term dosing of etravirine in HIV-negative volunteers was generally safe and well tolerated.</abstract><cop>Los Angeles, CA</cop><pub>Harvey Whitney Books</pub><pmid>18445705</pmid><doi>10.1345/aph.1K681</doi><tpages>9</tpages></addata></record> |
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| ispartof | The Annals of pharmacotherapy, 2008-06, Vol.42 (6), p.757-765 |
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| source | MEDLINE; SAGE Complete A-Z List |
| subjects | Adolescent Adult Anti-HIV Agents - administration & dosage Anti-HIV Agents - adverse effects Anti-HIV Agents - pharmacokinetics Anti-Infective Agents - adverse effects Aza Compounds - adverse effects Biological and medical sciences Confidence Intervals Cross-Over Studies Dose-Response Relationship, Drug Double-Blind Method Electrocardiography Female Fluoroquinolones Follow-Up Studies Human viral diseases Humans Immunodeficiencies Immunodeficiencies. Immunoglobulinopathies Immunopathology Infectious diseases Male Medical sciences Middle Aged Pharmacology. Drug treatments Pyridazines - administration & dosage Pyridazines - adverse effects Pyridazines - pharmacokinetics Quinolines - adverse effects Sex Factors Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids |
| title | Etravirine Has No Effect on QT and Corrected QT Interval in HIV-Negative Volunteers |
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