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Incidence of virological failure and major regimen change of initial combination antiretroviral therapy in the Latin America and the Caribbean: An observational cohort study

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dc.contributor.author Cesar, C.
dc.contributor.author Jenkins, C.A.
dc.contributor.author Shepherd, B.E.
dc.contributor.author Padgett, D.
dc.contributor.author Mejía, F.
dc.contributor.author Ribeiro, S.R.
dc.contributor.author Cortes, C.P.
dc.contributor.author Pape, J.W.
dc.contributor.author Sierra Madero, J.
dc.contributor.author Fink, V.
dc.contributor.author Sued, O.
dc.contributor.author McGowan, C.
dc.contributor.author Cahn, P.
dc.contributor.author Grinsztejn, B.
dc.contributor.author Reyes, M.W.
dc.contributor.author Gotuzzo, E.
dc.contributor.author CCASAnet
dc.date.accessioned 2019-04-24T18:23:55Z
dc.date.available 2019-04-24T18:23:55Z
dc.date.issued 2015
dc.identifier.uri https://hdl.handle.net/20.500.12866/6484
dc.description.abstract Background: Access to combination antiretroviral therapy (ART) is expanding in Latin America (Mexico, Central America, and South America) and the Caribbean. We assessed the incidence of and factors associated with regimen failure and regimen change of initial ART in this region. Methods: This observational cohort study included antiretroviral-naive adults starting ART from 2000 to 2014 at sites in seven countries throughout Latin America and the Caribbean. Primary outcomes were time from ART initiation until virological failure, major regimen modification, and a composite endpoint of the first of virological failure or major regimen modification. Cumulative incidence of the primary outcomes was estimated with death considered a competing event. Findings: 14 027 patients starting ART were followed up for a median of 3·9 years (2·0-6·5): 8374 (60%) men, median age 37 years (IQR 30-44), median CD4 count 156 cells per μL (61-253), median plasma HIV RNA 5·0 log10 copies per mL (4·4-5·4), and 3567 (28%) had clinical AIDS. 1719 (12%) patients had virological failure and 1955 (14%) had a major regimen change. Excluding the site in Haiti, which did not regularly measure HIV RNA, cumulative incidence of virological failure was 7·8% (95% CI 7·2-8·5) 1 year after ART initiation, 19·2% (18·2-20·2) at 3 years, and 25·8% (24·6-27·0) at 5 years; cumulative incidence of major regimen change was 5·9% (5·3-6·4) at 1 year, 12·7% (11·9-13·5) at 3 years, and 18·2% (17·2-19·2) at 5 years. Incidence of major regimen change at the site in Haiti was 10·7% (95% CI 9·7-11·6) at 5 years. Virological failure was associated with younger age (adjusted hazard ratio [HR] 2·03, 95% CI 1·68-2·44, for 20 years vs 40 years), infection through injection drug use (vs infection through heterosexual sex; 1·60, 1·02-2·52), and initiation in earlier calendar years (1·28, 1·13-1·46, for 2002 vs 2006), but was not significantly associated with boosted protease inhibitor-based regimens (vs non-nucleoside reverse transcriptase inhibitor; 1·17, 1·00-1·36). Interpretation: Incidence of virological failure in Latin America and the Caribbean was generally lower than that reported in North America or Europe. Our results suggest the need to design strategies to reduce failure and major regimen change in young patients and those with a history of injection drug use. en_US
dc.language.iso eng
dc.publisher Elsevier
dc.relation.ispartof urn:issn:2352-3018
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject stavudine en_US
dc.subject tenofovir en_US
dc.subject virus RNA en_US
dc.subject zidovudine en_US
dc.subject anti human immunodeficiency virus agent en_US
dc.subject acquired immune deficiency syndrome en_US
dc.subject adult en_US
dc.subject age distribution en_US
dc.subject Article en_US
dc.subject Caribbean en_US
dc.subject CD4 lymphocyte count en_US
dc.subject cohort analysis en_US
dc.subject drug dose regimen en_US
dc.subject female en_US
dc.subject gene dosage en_US
dc.subject heterosexuality en_US
dc.subject highly active antiretroviral therapy en_US
dc.subject human en_US
dc.subject Human immunodeficiency virus infection en_US
dc.subject intravenous drug abuse en_US
dc.subject major clinical study en_US
dc.subject male en_US
dc.subject mortality en_US
dc.subject priority journal en_US
dc.subject sensitivity analysis en_US
dc.subject South and Central America en_US
dc.subject treatment failure en_US
dc.subject treatment outcome en_US
dc.subject virological failure en_US
dc.subject virus load en_US
dc.subject clinical protocol en_US
dc.subject clinical trial en_US
dc.subject combination drug therapy en_US
dc.subject drug administration en_US
dc.subject drug effects en_US
dc.subject drug substitution en_US
dc.subject HIV Infections en_US
dc.subject immunology en_US
dc.subject incidence en_US
dc.subject multicenter study en_US
dc.subject statistics and numerical data en_US
dc.subject Adult en_US
dc.subject Anti-HIV Agents en_US
dc.subject Caribbean Region en_US
dc.subject CD4 Lymphocyte Count en_US
dc.subject Clinical Protocols en_US
dc.subject Drug Administration Schedule en_US
dc.subject Drug Substitution en_US
dc.subject Drug Therapy, Combination en_US
dc.subject Female en_US
dc.subject HIV Infections en_US
dc.subject Humans en_US
dc.subject Incidence en_US
dc.subject Latin America en_US
dc.subject Male en_US
dc.subject Treatment Outcome en_US
dc.subject Viral Load en_US
dc.title Incidence of virological failure and major regimen change of initial combination antiretroviral therapy in the Latin America and the Caribbean: An observational cohort study en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1016/S2352-3018(15)00183-6
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00 es_PE

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