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dc.contributor.authorRoutman, Justin S.
dc.contributor.authorWillig, James H.
dc.contributor.authorWestfall, Andrew O.
dc.contributor.authorAbroms, Sarah R.
dc.contributor.authorVarshney, Mohit
dc.contributor.authorAdusumilli, Sunil
dc.contributor.authorAllison, Jeroan J.
dc.contributor.authorSavage, Karen G.
dc.contributor.authorSaag, Michael S.
dc.contributor.authorMugavero, Michael J.
dc.date2022-08-11T08:10:44.000
dc.date.accessioned2022-08-23T17:18:16Z
dc.date.available2022-08-23T17:18:16Z
dc.date.issued2010-02-15
dc.date.submitted2011-01-27
dc.identifier.citationClin Infect Dis. 2010 Feb 15;50(4):574-84. <a href="http://dx.doi.org/10.1086/650004">Link to article on publisher's site</a>
dc.identifier.issn1058-4838 (Linking)
dc.identifier.doi10.1086/650004
dc.identifier.pmid20067423
dc.identifier.urihttp://hdl.handle.net/20.500.14038/47819
dc.description.abstractBACKGROUND: The applicability of clinical trial findings (efficacy) to the routine care setting (effectiveness) may be limited because of study eligibility criteria and volunteer bias. Although well-chronicled in many conditions, the efficacy versus effectiveness of antiretroviral therapy (ART) remains understudied. METHODS: A retrospective study of the University of Alabama at Birmingham 1917 Clinic Cohort evaluated ART-naive patients who started ART from 1 January 2000 through 31 December 2006. Patients received ART through clinical trials or routine care. Multivariable logistic and linear regression models were fit to evaluate factors associated with virological failure (virological failure was defined as a viral load >50 copies/mL) and change from baseline CD4+ cell count 6 and 12 months after ART initiation. Sensitivity analyses evaluated the impact of missing data on outcomes. RESULTS: Among 570 patients starting ART during the study period, 121 (21%) enrolled in clinical trials, and 449 (79%) received ART via routine care. ART receipt through routine care was not associated with viral failure at either 6 months (odds ratio [OR], 1.00; 95% confidence interval [CI], 0.54-1.86) or 12 months (OR, 1.56; 95% CI, 0.80-3.05) in primary analyses. No statistically significant differences in CD4+ cell count responses at 6 and 12 months were observed. CONCLUSIONS: Although marked differences in efficacy versus effectiveness have been observed in the therapeutic outcomes of other conditions, our analyses found no evidence of such divergence among our patients who initiated antiretroviral therapy for human immunodeficiency virus infection.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=20067423&dopt=Abstract">Link to Article in PubMed</a>
dc.subjectAdult
dc.subjectAnti-Retroviral Agents
dc.subjectCD4 Lymphocyte Count
dc.subjectFemale
dc.subjectHIV
dc.subjectHIV Infections
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectMultivariate Analysis
dc.subjectRNA, Viral
dc.subjectRegression Analysis
dc.subjectRetrospective Studies
dc.subjectRisk Factors
dc.subjectSensitivity and Specificity
dc.subjectTreatment Outcome
dc.subjectViral Load
dc.subjectBioinformatics
dc.subjectBiostatistics
dc.subjectEpidemiology
dc.subjectHealth Services Research
dc.titleComparative efficacy versus effectiveness of initial antiretroviral therapy in clinical trials versus routine care
dc.typeJournal Article
dc.source.journaltitleClinical infectious diseases : an official publication of the Infectious Diseases Society of America
dc.source.volume50
dc.source.issue4
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=1934&amp;context=qhs_pp&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/qhs_pp/934
dc.identifier.contextkey1749241
refterms.dateFOA2022-08-23T17:18:17Z
html.description.abstract<p>BACKGROUND: The applicability of clinical trial findings (efficacy) to the routine care setting (effectiveness) may be limited because of study eligibility criteria and volunteer bias. Although well-chronicled in many conditions, the efficacy versus effectiveness of antiretroviral therapy (ART) remains understudied.</p> <p>METHODS: A retrospective study of the University of Alabama at Birmingham 1917 Clinic Cohort evaluated ART-naive patients who started ART from 1 January 2000 through 31 December 2006. Patients received ART through clinical trials or routine care. Multivariable logistic and linear regression models were fit to evaluate factors associated with virological failure (virological failure was defined as a viral load >50 copies/mL) and change from baseline CD4+ cell count 6 and 12 months after ART initiation. Sensitivity analyses evaluated the impact of missing data on outcomes.</p> <p>RESULTS: Among 570 patients starting ART during the study period, 121 (21%) enrolled in clinical trials, and 449 (79%) received ART via routine care. ART receipt through routine care was not associated with viral failure at either 6 months (odds ratio [OR], 1.00; 95% confidence interval [CI], 0.54-1.86) or 12 months (OR, 1.56; 95% CI, 0.80-3.05) in primary analyses. No statistically significant differences in CD4+ cell count responses at 6 and 12 months were observed.</p> <p>CONCLUSIONS: Although marked differences in efficacy versus effectiveness have been observed in the therapeutic outcomes of other conditions, our analyses found no evidence of such divergence among our patients who initiated antiretroviral therapy for human immunodeficiency virus infection.</p>
dc.identifier.submissionpathqhs_pp/934
dc.contributor.departmentDepartment of Quantitative Health Sciences
dc.source.pages574-84


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