Efficacy and Safety Outcomes Among Treatment-Experienced Women and Men Treated with Etravirine in Gender, Race and Clinical Experience
The GRACE (Gender, Race and Clinical Experience) trial enrolled treatment-experienced, HIV-1-infected patients, mainly women, in North America, to assess outcomes with a darunavir/ritonavir-based regimen, which could include etravirine (ETR). We present outcomes at week 48 for men and women receivin...
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| Veröffentlicht in: | AIDS research and human retroviruses 2012-06, Vol.28 (6), p.544-551 |
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| creator | HODDER, Sally JAYAWEERA, Dushyantha MRUS, Joseph RYAN, Robert WITEK, James |
| description | The GRACE (Gender, Race and Clinical Experience) trial enrolled treatment-experienced, HIV-1-infected patients, mainly women, in North America, to assess outcomes with a darunavir/ritonavir-based regimen, which could include etravirine (ETR). We present outcomes at week 48 for men and women receiving ETR. Virologic response (HIV-1 RNA |
| doi_str_mv | 10.1089/aid.2011.0118 |
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We present outcomes at week 48 for men and women receiving ETR. Virologic response (HIV-1 RNA <50 copies/ml) and safety were assessed; descriptive statistics are reported. To evaluate the independent contribution of ETR treatment, a post hoc analysis including a multivariate model assessed factors predictive of virologic response for the entire GRACE population (429 patients). Of 207 patients who received ETR (women, 57.5%; black or Hispanic, 81.7%), 71.4% of women and 79.5% of men completed the study. Week 48 virologic response rates in women and men (intent-to-treat population) were 58.0% and 61.4%, respectively. After censoring patients who discontinued treatment for reasons other than virologic failure, response rates were 79.3% and 73.0%, respectively. Overall, ETR was well tolerated. Women experienced more nausea (24.4% vs. 11.4%) and rash-related events (21.0% vs. 15.9%), but less diarrhea (15.1% vs. 21.6%), compared with men. Grade 3-4 hypertriglyceridemia was more common in men (9.3%) than women (1.1%). In total, 11 (9.2%) women and 7 (8.0%) men discontinued ETR due to adverse events. In the multivariate model of the entire GRACE population, ETR use was independently associated with improved virologic response. ETR is effective and well tolerated in treatment-experienced patients with HIV-1, with similar outcomes among women and men.</description><identifier>ISSN: 0889-2229</identifier><identifier>EISSN: 1931-8405</identifier><identifier>DOI: 10.1089/aid.2011.0118</identifier><identifier>PMID: 22206504</identifier><identifier>CODEN: ARHRE7</identifier><language>eng</language><publisher>New Rochelle, NY: Liebert</publisher><subject>Acquired immune deficiency syndrome ; Acquired Immunodeficiency Syndrome - drug therapy ; Acquired Immunodeficiency Syndrome - epidemiology ; Acquired Immunodeficiency Syndrome - immunology ; Adult ; AIDS/HIV ; Anti-HIV Agents - therapeutic use ; Biological and medical sciences ; Clinical trials ; Darunavir ; Diarrhea ; Drug Resistance, Multiple, Viral - immunology ; Ethnic groups ; Female ; Females ; Fundamental and applied biological sciences. Psychology ; Gender ; HIV Protease Inhibitors - therapeutic use ; HIV-1 - immunology ; Human immunodeficiency virus 1 ; Human viral diseases ; Humans ; Hypertriglyceridemia ; Infectious diseases ; Male ; Males ; Medical sciences ; Microbiology ; Miscellaneous ; Nausea ; North America - epidemiology ; Pyridazines - therapeutic use ; Races ; Retrovirus ; Ritonavir - therapeutic use ; RNA ; RNA, Viral - drug effects ; Sex Distribution ; Sex Factors ; Side effects ; Statistical analysis ; Sulfonamides - therapeutic use ; Treatment Outcome ; Viral diseases ; Viral Load - drug effects ; Virology</subject><ispartof>AIDS research and human retroviruses, 2012-06, Vol.28 (6), p.544-551</ispartof><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-29ad8b7b65ed59135ee570279c4bc5552ec0ccb8a8ad0452e9a20e1126171a2a3</citedby><cites>FETCH-LOGICAL-c356t-29ad8b7b65ed59135ee570279c4bc5552ec0ccb8a8ad0452e9a20e1126171a2a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3029,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26259230$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22206504$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>HODDER, Sally</creatorcontrib><creatorcontrib>JAYAWEERA, Dushyantha</creatorcontrib><creatorcontrib>MRUS, Joseph</creatorcontrib><creatorcontrib>RYAN, Robert</creatorcontrib><creatorcontrib>WITEK, James</creatorcontrib><creatorcontrib>Grace Study Group</creatorcontrib><title>Efficacy and Safety Outcomes Among Treatment-Experienced Women and Men Treated with Etravirine in Gender, Race and Clinical Experience</title><title>AIDS research and human retroviruses</title><addtitle>AIDS Res Hum Retroviruses</addtitle><description>The GRACE (Gender, Race and Clinical Experience) trial enrolled treatment-experienced, HIV-1-infected patients, mainly women, in North America, to assess outcomes with a darunavir/ritonavir-based regimen, which could include etravirine (ETR). We present outcomes at week 48 for men and women receiving ETR. Virologic response (HIV-1 RNA <50 copies/ml) and safety were assessed; descriptive statistics are reported. To evaluate the independent contribution of ETR treatment, a post hoc analysis including a multivariate model assessed factors predictive of virologic response for the entire GRACE population (429 patients). Of 207 patients who received ETR (women, 57.5%; black or Hispanic, 81.7%), 71.4% of women and 79.5% of men completed the study. Week 48 virologic response rates in women and men (intent-to-treat population) were 58.0% and 61.4%, respectively. After censoring patients who discontinued treatment for reasons other than virologic failure, response rates were 79.3% and 73.0%, respectively. Overall, ETR was well tolerated. Women experienced more nausea (24.4% vs. 11.4%) and rash-related events (21.0% vs. 15.9%), but less diarrhea (15.1% vs. 21.6%), compared with men. Grade 3-4 hypertriglyceridemia was more common in men (9.3%) than women (1.1%). In total, 11 (9.2%) women and 7 (8.0%) men discontinued ETR due to adverse events. In the multivariate model of the entire GRACE population, ETR use was independently associated with improved virologic response. ETR is effective and well tolerated in treatment-experienced patients with HIV-1, with similar outcomes among women and men.</description><subject>Acquired immune deficiency syndrome</subject><subject>Acquired Immunodeficiency Syndrome - drug therapy</subject><subject>Acquired Immunodeficiency Syndrome - epidemiology</subject><subject>Acquired Immunodeficiency Syndrome - immunology</subject><subject>Adult</subject><subject>AIDS/HIV</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Clinical trials</subject><subject>Darunavir</subject><subject>Diarrhea</subject><subject>Drug Resistance, Multiple, Viral - immunology</subject><subject>Ethnic groups</subject><subject>Female</subject><subject>Females</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Gender</subject><subject>HIV Protease Inhibitors - therapeutic use</subject><subject>HIV-1 - immunology</subject><subject>Human immunodeficiency virus 1</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Hypertriglyceridemia</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Males</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Miscellaneous</subject><subject>Nausea</subject><subject>North America - epidemiology</subject><subject>Pyridazines - therapeutic use</subject><subject>Races</subject><subject>Retrovirus</subject><subject>Ritonavir - therapeutic use</subject><subject>RNA</subject><subject>RNA, Viral - drug effects</subject><subject>Sex Distribution</subject><subject>Sex Factors</subject><subject>Side effects</subject><subject>Statistical analysis</subject><subject>Sulfonamides - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Viral diseases</subject><subject>Viral Load - drug effects</subject><subject>Virology</subject><issn>0889-2229</issn><issn>1931-8405</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkU1PGzEQhq2KqoS0x14rX5A4sMEf6419RFEakEBIQNXjatY727ra9ab2Bpo_wO-u8wG5crBHHj1-R5qHkK-cTTjT5gJcPRGM80k6-gMZcSN5pnOmjsiIaW0yIYQ5Jicx_mGMGSHUJ3KceqxQLB-Rl3nTOAt2TcHX9AEaHNb0bjXYvsNIL7ve_6KPAWHo0A_Z_N8Sg0NvsaY_E-G3v25T3TKp--yG33Q-BHhywXmkztMF-hrDOb0Hi1t-1jqfZrb0EPeZfGygjfhlX8fkx_f54-wqu7lbXM8ubzIrVTFkwkCtq2lVKKyV4VIhqikTU2PzyiqlBFpmbaVBQ83y9DQgGHIuCj7lIECOydkudxn6vyuMQ9m5aLFtwWO_iiVnaUGFkSZ_B8p1IeXmGpNsh9rQxxiwKZfBdRDWCSo3lspkqdxYKjeWEv9tH72qOqzf6FctCTjdAxDTopoA3rp44AqhjJBM_geLc5oZ</recordid><startdate>20120601</startdate><enddate>20120601</enddate><creator>HODDER, Sally</creator><creator>JAYAWEERA, Dushyantha</creator><creator>MRUS, Joseph</creator><creator>RYAN, Robert</creator><creator>WITEK, James</creator><general>Liebert</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>7T2</scope><scope>7U2</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope></search><sort><creationdate>20120601</creationdate><title>Efficacy and Safety Outcomes Among Treatment-Experienced Women and Men Treated with Etravirine in Gender, Race and Clinical Experience</title><author>HODDER, Sally ; JAYAWEERA, Dushyantha ; MRUS, Joseph ; RYAN, Robert ; WITEK, James</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-29ad8b7b65ed59135ee570279c4bc5552ec0ccb8a8ad0452e9a20e1126171a2a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>Acquired Immunodeficiency Syndrome - drug therapy</topic><topic>Acquired Immunodeficiency Syndrome - epidemiology</topic><topic>Acquired Immunodeficiency Syndrome - immunology</topic><topic>Adult</topic><topic>AIDS/HIV</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Clinical trials</topic><topic>Darunavir</topic><topic>Diarrhea</topic><topic>Drug Resistance, Multiple, Viral - immunology</topic><topic>Ethnic groups</topic><topic>Female</topic><topic>Females</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Gender</topic><topic>HIV Protease Inhibitors - therapeutic use</topic><topic>HIV-1 - immunology</topic><topic>Human immunodeficiency virus 1</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Hypertriglyceridemia</topic><topic>Infectious diseases</topic><topic>Male</topic><topic>Males</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Miscellaneous</topic><topic>Nausea</topic><topic>North America - epidemiology</topic><topic>Pyridazines - therapeutic use</topic><topic>Races</topic><topic>Retrovirus</topic><topic>Ritonavir - therapeutic use</topic><topic>RNA</topic><topic>RNA, Viral - drug effects</topic><topic>Sex Distribution</topic><topic>Sex Factors</topic><topic>Side effects</topic><topic>Statistical analysis</topic><topic>Sulfonamides - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Viral diseases</topic><topic>Viral Load - drug effects</topic><topic>Virology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>HODDER, Sally</creatorcontrib><creatorcontrib>JAYAWEERA, Dushyantha</creatorcontrib><creatorcontrib>MRUS, Joseph</creatorcontrib><creatorcontrib>RYAN, Robert</creatorcontrib><creatorcontrib>WITEK, James</creatorcontrib><creatorcontrib>Grace Study Group</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>Health and Safety Science Abstracts (Full archive)</collection><collection>Safety Science and Risk</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>AIDS research and human retroviruses</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>HODDER, Sally</au><au>JAYAWEERA, Dushyantha</au><au>MRUS, Joseph</au><au>RYAN, Robert</au><au>WITEK, James</au><aucorp>Grace Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety Outcomes Among Treatment-Experienced Women and Men Treated with Etravirine in Gender, Race and Clinical Experience</atitle><jtitle>AIDS research and human retroviruses</jtitle><addtitle>AIDS Res Hum Retroviruses</addtitle><date>2012-06-01</date><risdate>2012</risdate><volume>28</volume><issue>6</issue><spage>544</spage><epage>551</epage><pages>544-551</pages><issn>0889-2229</issn><eissn>1931-8405</eissn><coden>ARHRE7</coden><abstract>The GRACE (Gender, Race and Clinical Experience) trial enrolled treatment-experienced, HIV-1-infected patients, mainly women, in North America, to assess outcomes with a darunavir/ritonavir-based regimen, which could include etravirine (ETR). We present outcomes at week 48 for men and women receiving ETR. Virologic response (HIV-1 RNA <50 copies/ml) and safety were assessed; descriptive statistics are reported. To evaluate the independent contribution of ETR treatment, a post hoc analysis including a multivariate model assessed factors predictive of virologic response for the entire GRACE population (429 patients). Of 207 patients who received ETR (women, 57.5%; black or Hispanic, 81.7%), 71.4% of women and 79.5% of men completed the study. Week 48 virologic response rates in women and men (intent-to-treat population) were 58.0% and 61.4%, respectively. After censoring patients who discontinued treatment for reasons other than virologic failure, response rates were 79.3% and 73.0%, respectively. Overall, ETR was well tolerated. Women experienced more nausea (24.4% vs. 11.4%) and rash-related events (21.0% vs. 15.9%), but less diarrhea (15.1% vs. 21.6%), compared with men. Grade 3-4 hypertriglyceridemia was more common in men (9.3%) than women (1.1%). In total, 11 (9.2%) women and 7 (8.0%) men discontinued ETR due to adverse events. In the multivariate model of the entire GRACE population, ETR use was independently associated with improved virologic response. ETR is effective and well tolerated in treatment-experienced patients with HIV-1, with similar outcomes among women and men.</abstract><cop>New Rochelle, NY</cop><pub>Liebert</pub><pmid>22206504</pmid><doi>10.1089/aid.2011.0118</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0889-2229 |
| ispartof | AIDS research and human retroviruses, 2012-06, Vol.28 (6), p.544-551 |
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| source | Mary Ann Liebert Online Subscription; MEDLINE; Alma/SFX Local Collection |
| subjects | Acquired immune deficiency syndrome Acquired Immunodeficiency Syndrome - drug therapy Acquired Immunodeficiency Syndrome - epidemiology Acquired Immunodeficiency Syndrome - immunology Adult AIDS/HIV Anti-HIV Agents - therapeutic use Biological and medical sciences Clinical trials Darunavir Diarrhea Drug Resistance, Multiple, Viral - immunology Ethnic groups Female Females Fundamental and applied biological sciences. Psychology Gender HIV Protease Inhibitors - therapeutic use HIV-1 - immunology Human immunodeficiency virus 1 Human viral diseases Humans Hypertriglyceridemia Infectious diseases Male Males Medical sciences Microbiology Miscellaneous Nausea North America - epidemiology Pyridazines - therapeutic use Races Retrovirus Ritonavir - therapeutic use RNA RNA, Viral - drug effects Sex Distribution Sex Factors Side effects Statistical analysis Sulfonamides - therapeutic use Treatment Outcome Viral diseases Viral Load - drug effects Virology |
| title | Efficacy and Safety Outcomes Among Treatment-Experienced Women and Men Treated with Etravirine in Gender, Race and Clinical Experience |
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