Disease progression in HIV-infected patients treated with stavudine vs. zidovudine
This prospective, observational study compared disease progression and death in HIV-1 patients treated with stavudine vs. zidovudine in the Collaborations in HIV Outcomes Research/U.S. (CHORUS) cohort. Patients with a first occurrence of CD4 count
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| Veröffentlicht in: | Journal of clinical epidemiology 2004-01, Vol.57 (1), p.89-97 |
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| container_title | Journal of clinical epidemiology |
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| creator | Justice, Amy C Stein, Daniel S Fusco, Gregory P Sherrill, Beth H Fusco, Jennifer S Danehower, Susan C Becker, Stephen L Hansen, Nellie I Graham, Neil M.H the CHORUS Program Team |
| description | This prospective, observational study compared disease progression and death in HIV-1 patients treated with stavudine vs. zidovudine in the Collaborations in HIV Outcomes Research/U.S. (CHORUS) cohort.
Patients with a first occurrence of CD4 count |
| doi_str_mv | 10.1016/S0895-4356(03)00245-2 |
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Patients with a first occurrence of CD4 count <500 cells/μL (n=3301) were grouped as: no nucleoside reverse transcriptase inhibitor (NRTI) use; other NRTI without stavudine or zidovudine; stavudine with no zidovudine, with or without other NRTIs; and zidovudine with no stavudine, with or without other NRTIs. The risk for death or disease progression was evaluated in unadjusted analyses and using a Cox proportional hazards model, adjusting for: study site, age, gender, race, route of HIV infection, previous AIDS-defining conditions, number of previous antiretroviral regiments, CD4 count, HIV-1 RNA, and treatment variables. Sensitivity analyses were conducted to determine the sensitivity of the results to major modeling assumptions. A landmark analysis was conducted to determine the absolute difference in time to event.
During a median follow-up of 2.4 years, there were 57 deaths and 348 AIDS-defining conditions in 405 patients. Stavudine treatment compared with zidovudine resulted in a greater percentage of patients with AIDS-defining events (14.5 vs. 10.9%; P=.013), and an increased risk of disease progression (HR=1.30; 95% CI: 1.01,1.7; P=.04). This result was not sensitive to modeling assumptions. Landmark analysis demonstrated an absolute difference in time to 95% event-free survival of 2.7 months for those with a CD4⩽200 cells/μL and 11 months for those 6 months after model entry.
In unadjusted and adjusted analyses of 3301 HIV-1 infected patients, stavudine containing combination therapy was associated with an increased risk of disease progression or death compared to therapy containing zidovudine. Most of the difference was attributable to new cases of wasting.</description><identifier>ISSN: 0895-4356</identifier><identifier>EISSN: 1878-5921</identifier><identifier>DOI: 10.1016/S0895-4356(03)00245-2</identifier><identifier>PMID: 15019015</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Acquired immune deficiency syndrome ; Acquired Immunodeficiency Syndrome - diagnosis ; AIDS ; Anti-HIV Agents - therapeutic use ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiretroviral agents ; Antiretroviral Therapy, Highly Active ; Antiviral agents ; Biological and medical sciences ; Chi-square test ; CHORUS ; Clinical outcomes ; Data collection ; Databases, Factual ; Disease prevention ; Disease Progression ; Disease-Free Survival ; Drug therapy ; Epidemiology ; Ethnicity ; Follow-Up Studies ; Health risks ; HIV ; HIV Infections - drug therapy ; HIV Infections - mortality ; HIV wasting ; HIV Wasting Syndrome - diagnosis ; Human immunodeficiency virus ; Human immunodeficiency virus 1 ; Human viral diseases ; Humans ; Infectious diseases ; Longitudinal study ; Medical sciences ; Mitochondrial DNA ; Mortality ; Observational studies ; Patients ; Pharmacology. Drug treatments ; Proportional Hazards Models ; Prospective Studies ; Reverse Transcriptase Inhibitors - therapeutic use ; Sensitivity analysis ; Stavudine ; Stavudine - therapeutic use ; Toxicity ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Zidovudine ; Zidovudine - therapeutic use</subject><ispartof>Journal of clinical epidemiology, 2004-01, Vol.57 (1), p.89-97</ispartof><rights>2004 Elsevier Inc.</rights><rights>2004 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c450t-98875e80b8fe87ca18ecf2417a8a35a48f8e1d72380ecc921e204c706d4e9f93</citedby><cites>FETCH-LOGICAL-c450t-98875e80b8fe87ca18ecf2417a8a35a48f8e1d72380ecc921e204c706d4e9f93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0895435603002452$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,4010,27900,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15511260$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15019015$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Justice, Amy C</creatorcontrib><creatorcontrib>Stein, Daniel S</creatorcontrib><creatorcontrib>Fusco, Gregory P</creatorcontrib><creatorcontrib>Sherrill, Beth H</creatorcontrib><creatorcontrib>Fusco, Jennifer S</creatorcontrib><creatorcontrib>Danehower, Susan C</creatorcontrib><creatorcontrib>Becker, Stephen L</creatorcontrib><creatorcontrib>Hansen, Nellie I</creatorcontrib><creatorcontrib>Graham, Neil M.H</creatorcontrib><creatorcontrib>the CHORUS Program Team</creatorcontrib><creatorcontrib>CHORUS Program Team</creatorcontrib><title>Disease progression in HIV-infected patients treated with stavudine vs. zidovudine</title><title>Journal of clinical epidemiology</title><addtitle>J Clin Epidemiol</addtitle><description>This prospective, observational study compared disease progression and death in HIV-1 patients treated with stavudine vs. zidovudine in the Collaborations in HIV Outcomes Research/U.S. (CHORUS) cohort.
Patients with a first occurrence of CD4 count <500 cells/μL (n=3301) were grouped as: no nucleoside reverse transcriptase inhibitor (NRTI) use; other NRTI without stavudine or zidovudine; stavudine with no zidovudine, with or without other NRTIs; and zidovudine with no stavudine, with or without other NRTIs. The risk for death or disease progression was evaluated in unadjusted analyses and using a Cox proportional hazards model, adjusting for: study site, age, gender, race, route of HIV infection, previous AIDS-defining conditions, number of previous antiretroviral regiments, CD4 count, HIV-1 RNA, and treatment variables. Sensitivity analyses were conducted to determine the sensitivity of the results to major modeling assumptions. A landmark analysis was conducted to determine the absolute difference in time to event.
During a median follow-up of 2.4 years, there were 57 deaths and 348 AIDS-defining conditions in 405 patients. Stavudine treatment compared with zidovudine resulted in a greater percentage of patients with AIDS-defining events (14.5 vs. 10.9%; P=.013), and an increased risk of disease progression (HR=1.30; 95% CI: 1.01,1.7; P=.04). This result was not sensitive to modeling assumptions. Landmark analysis demonstrated an absolute difference in time to 95% event-free survival of 2.7 months for those with a CD4⩽200 cells/μL and 11 months for those 6 months after model entry.
In unadjusted and adjusted analyses of 3301 HIV-1 infected patients, stavudine containing combination therapy was associated with an increased risk of disease progression or death compared to therapy containing zidovudine. Most of the difference was attributable to new cases of wasting.</description><subject>Acquired immune deficiency syndrome</subject><subject>Acquired Immunodeficiency Syndrome - diagnosis</subject><subject>AIDS</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiretroviral agents</subject><subject>Antiretroviral Therapy, Highly Active</subject><subject>Antiviral agents</subject><subject>Biological and medical sciences</subject><subject>Chi-square test</subject><subject>CHORUS</subject><subject>Clinical outcomes</subject><subject>Data collection</subject><subject>Databases, Factual</subject><subject>Disease prevention</subject><subject>Disease Progression</subject><subject>Disease-Free Survival</subject><subject>Drug therapy</subject><subject>Epidemiology</subject><subject>Ethnicity</subject><subject>Follow-Up Studies</subject><subject>Health risks</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - mortality</subject><subject>HIV wasting</subject><subject>HIV Wasting Syndrome - diagnosis</subject><subject>Human immunodeficiency virus</subject><subject>Human immunodeficiency virus 1</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Longitudinal study</subject><subject>Medical sciences</subject><subject>Mitochondrial DNA</subject><subject>Mortality</subject><subject>Observational studies</subject><subject>Patients</subject><subject>Pharmacology. Drug treatments</subject><subject>Proportional Hazards Models</subject><subject>Prospective Studies</subject><subject>Reverse Transcriptase Inhibitors - therapeutic use</subject><subject>Sensitivity analysis</subject><subject>Stavudine</subject><subject>Stavudine - therapeutic use</subject><subject>Toxicity</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Zidovudine</subject><subject>Zidovudine - therapeutic use</subject><issn>0895-4356</issn><issn>1878-5921</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkVFrFDEQx4NY2rP2IygLUrEP285kk032SUrVtlAQ2tLXkGZnNeVu98zsnuinb653qPjSpzDhN8N_5ifEG4RjBKxPbsA2ulSVrj9AdQQglS7lCzFDa2ypG4kvxewPsideMT8AoAGjd8UeasAGUM_E9afI5JmKZRq-JWKOQ1_Evri4vCtj31EYqS2WfozUj1yMifz642ccvxc8-tXUxp6KFR8Xv2M7bMrXYqfzc6aD7bsvbr98vj27KK--nl-enV6VQWkYy8Zao8nCve3ImuDRUuikQuOtr7RXtrOErZGVBQohL0QSVDBQt4qarqn2xfvN2Jz8x0Q8ukXkQPO572mY2Bk0sjaqfhZEY4yWDWTw3X_gwzClPu_gECqlsDKNyZTeUCENzIk6t0xx4dOvDLm1Gvekxq3v7qByT2qczH1vt9On-wW1f7u2LjJwuAU8Bz_vku9D5H84jSjrdcyPG47ycVeRkuOQ9QRqY8q-XDvEZ6I8AhC-qcg</recordid><startdate>200401</startdate><enddate>200401</enddate><creator>Justice, Amy C</creator><creator>Stein, Daniel S</creator><creator>Fusco, Gregory P</creator><creator>Sherrill, Beth H</creator><creator>Fusco, Jennifer S</creator><creator>Danehower, Susan C</creator><creator>Becker, Stephen L</creator><creator>Hansen, Nellie I</creator><creator>Graham, Neil M.H</creator><creator>the CHORUS Program Team</creator><general>Elsevier Inc</general><general>Elsevier</general><general>Elsevier Limited</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>3V.</scope><scope>7QL</scope><scope>7QP</scope><scope>7RV</scope><scope>7T2</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>200401</creationdate><title>Disease progression in HIV-infected patients treated with stavudine vs. zidovudine</title><author>Justice, Amy C ; Stein, Daniel S ; Fusco, Gregory P ; Sherrill, Beth H ; Fusco, Jennifer S ; Danehower, Susan C ; Becker, Stephen L ; Hansen, Nellie I ; Graham, Neil M.H ; the CHORUS Program Team</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c450t-98875e80b8fe87ca18ecf2417a8a35a48f8e1d72380ecc921e204c706d4e9f93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>Acquired Immunodeficiency Syndrome - diagnosis</topic><topic>AIDS</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiretroviral agents</topic><topic>Antiretroviral Therapy, Highly Active</topic><topic>Antiviral agents</topic><topic>Biological and medical sciences</topic><topic>Chi-square test</topic><topic>CHORUS</topic><topic>Clinical outcomes</topic><topic>Data collection</topic><topic>Databases, Factual</topic><topic>Disease prevention</topic><topic>Disease Progression</topic><topic>Disease-Free Survival</topic><topic>Drug therapy</topic><topic>Epidemiology</topic><topic>Ethnicity</topic><topic>Follow-Up Studies</topic><topic>Health risks</topic><topic>HIV</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - mortality</topic><topic>HIV wasting</topic><topic>HIV Wasting Syndrome - diagnosis</topic><topic>Human immunodeficiency virus</topic><topic>Human immunodeficiency virus 1</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Longitudinal study</topic><topic>Medical sciences</topic><topic>Mitochondrial DNA</topic><topic>Mortality</topic><topic>Observational studies</topic><topic>Patients</topic><topic>Pharmacology. Drug treatments</topic><topic>Proportional Hazards Models</topic><topic>Prospective Studies</topic><topic>Reverse Transcriptase Inhibitors - therapeutic use</topic><topic>Sensitivity analysis</topic><topic>Stavudine</topic><topic>Stavudine - therapeutic use</topic><topic>Toxicity</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><topic>Zidovudine</topic><topic>Zidovudine - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Justice, Amy C</creatorcontrib><creatorcontrib>Stein, Daniel S</creatorcontrib><creatorcontrib>Fusco, Gregory P</creatorcontrib><creatorcontrib>Sherrill, Beth H</creatorcontrib><creatorcontrib>Fusco, Jennifer S</creatorcontrib><creatorcontrib>Danehower, Susan C</creatorcontrib><creatorcontrib>Becker, Stephen L</creatorcontrib><creatorcontrib>Hansen, Nellie I</creatorcontrib><creatorcontrib>Graham, Neil M.H</creatorcontrib><creatorcontrib>the CHORUS Program Team</creatorcontrib><creatorcontrib>CHORUS Program Team</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>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical epidemiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Justice, Amy C</au><au>Stein, Daniel S</au><au>Fusco, Gregory P</au><au>Sherrill, Beth H</au><au>Fusco, Jennifer S</au><au>Danehower, Susan C</au><au>Becker, Stephen L</au><au>Hansen, Nellie I</au><au>Graham, Neil M.H</au><au>the CHORUS Program Team</au><aucorp>CHORUS Program Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Disease progression in HIV-infected patients treated with stavudine vs. zidovudine</atitle><jtitle>Journal of clinical epidemiology</jtitle><addtitle>J Clin Epidemiol</addtitle><date>2004-01</date><risdate>2004</risdate><volume>57</volume><issue>1</issue><spage>89</spage><epage>97</epage><pages>89-97</pages><issn>0895-4356</issn><eissn>1878-5921</eissn><abstract>This prospective, observational study compared disease progression and death in HIV-1 patients treated with stavudine vs. zidovudine in the Collaborations in HIV Outcomes Research/U.S. (CHORUS) cohort.
Patients with a first occurrence of CD4 count <500 cells/μL (n=3301) were grouped as: no nucleoside reverse transcriptase inhibitor (NRTI) use; other NRTI without stavudine or zidovudine; stavudine with no zidovudine, with or without other NRTIs; and zidovudine with no stavudine, with or without other NRTIs. The risk for death or disease progression was evaluated in unadjusted analyses and using a Cox proportional hazards model, adjusting for: study site, age, gender, race, route of HIV infection, previous AIDS-defining conditions, number of previous antiretroviral regiments, CD4 count, HIV-1 RNA, and treatment variables. Sensitivity analyses were conducted to determine the sensitivity of the results to major modeling assumptions. A landmark analysis was conducted to determine the absolute difference in time to event.
During a median follow-up of 2.4 years, there were 57 deaths and 348 AIDS-defining conditions in 405 patients. Stavudine treatment compared with zidovudine resulted in a greater percentage of patients with AIDS-defining events (14.5 vs. 10.9%; P=.013), and an increased risk of disease progression (HR=1.30; 95% CI: 1.01,1.7; P=.04). This result was not sensitive to modeling assumptions. Landmark analysis demonstrated an absolute difference in time to 95% event-free survival of 2.7 months for those with a CD4⩽200 cells/μL and 11 months for those 6 months after model entry.
In unadjusted and adjusted analyses of 3301 HIV-1 infected patients, stavudine containing combination therapy was associated with an increased risk of disease progression or death compared to therapy containing zidovudine. Most of the difference was attributable to new cases of wasting.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>15019015</pmid><doi>10.1016/S0895-4356(03)00245-2</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0895-4356 |
| ispartof | Journal of clinical epidemiology, 2004-01, Vol.57 (1), p.89-97 |
| issn | 0895-4356 1878-5921 |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Acquired immune deficiency syndrome Acquired Immunodeficiency Syndrome - diagnosis AIDS Anti-HIV Agents - therapeutic use Antibiotics. Antiinfectious agents. Antiparasitic agents Antiretroviral agents Antiretroviral Therapy, Highly Active Antiviral agents Biological and medical sciences Chi-square test CHORUS Clinical outcomes Data collection Databases, Factual Disease prevention Disease Progression Disease-Free Survival Drug therapy Epidemiology Ethnicity Follow-Up Studies Health risks HIV HIV Infections - drug therapy HIV Infections - mortality HIV wasting HIV Wasting Syndrome - diagnosis Human immunodeficiency virus Human immunodeficiency virus 1 Human viral diseases Humans Infectious diseases Longitudinal study Medical sciences Mitochondrial DNA Mortality Observational studies Patients Pharmacology. Drug treatments Proportional Hazards Models Prospective Studies Reverse Transcriptase Inhibitors - therapeutic use Sensitivity analysis Stavudine Stavudine - therapeutic use Toxicity Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Zidovudine Zidovudine - therapeutic use |
| title | Disease progression in HIV-infected patients treated with stavudine vs. zidovudine |
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