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Unaí Tupinambáshttp://lattes.cnpq.br/9944131333164201Cristiane Aparecida Menezes de Páduahttp://lattes.cnpq.br/0999148325656924Helena DuaniGustavo Machado Rochahttp://lattes.cnpq.br/7695058308479920Gabriella Jomara da Silva2021-08-31T15:56:02Z2021-08-31T15:56:02Z2020-02-14http://hdl.handle.net/1843/37853https://orcid.org/0000-0001-8836-5052Introdução: Recentes mudanças no guia terapêutico em pessoas vivendo com o HIV (PVHIV) requer a avaliação da efetividade da terapia antirretroviral (TARV) utilizada na primeira linha de tratamento no cenário do mundo real. Objetivo: Avaliar a supressão viral em até 12 meses do início do tratamento com dolutegravir (DTG) vs. efavirenz (EFV), e verificar os fatores associados. Metodologia: Coorte histórica de PVHIV, ≥18 anos, que iniciaram a TARV entre 2015 e 2017 em Minas Gerais. Informações sobre idade, sexo, residência, carga viral (CV), linfócitos T CD4+ (LT-CD4+) e dispensação da TARV foram extraídas de duas bases de dados do Sistema Único de Saúde. A supressão viral (CV <50 cópias/mL) foi analisada em intenção de tratar (ITT) comparados com a análise conforme protocolo e com CV <1.000 cópias/mL. O tempo até o primeiro registro de CV <50 cópias/mL foi estimado pelo método de Kaplan-Meier. Modelo de riscos proporcionais de Cox para determinar os preditores para supressão viral nos seis primeiros meses. Regressão Logística foi utilizada para estimativa do Odds Ratio Ajustado (ORa) em até 12 meses. Considerou-se o nível de significância de 5% e o intervalo de confiança de 95% (IC95%). Resultados: Selecionado 2.599 indivíduos, 34% iniciaram tratamento com DTG e 66% com EFV. A maioria era do sexo masculino (77,5%), com mediana de idade 34 anos, exames basais de LT-CD4+ 322 céls/mmᵌ e CV 4,7 (log) cópias/mL. As trocas ocorreram em 5% das PVHIV que iniciaram com esquemas estruturados com DTG e 9,2% com EFV (p<0,0001). Em ITT, maior proporção de supressão viral foi observada para DTG comparado ao EFV (76,7% vs. 58,1%), mesmo quando considerado CV <1.000 cópias/mL (p<0,0001). Esquemas com DTG apresentaram menor tempo para o primeiro registro de CV <50 cópias/mL em seis meses (HR=1,29; IC95% 1,15 – 1,43) e maior chance de supressão viral em 12 meses (ORa=2,44; IC95% 2,01 – 2,95). Outras variáveis associadas ao desfecho foram tempo de início da TARV <120 dias, LT-CD4+ ≥200 céls/mmᵌ e CV basal <100.000 cópias/mL. Em análise conforme o protocolo foi observado maiores proporções de supressão viral e o mesmo intervalo de tempo até o desfecho em ambos os grupos da TARV. Conclusão: Após a introdução do DTG, houve melhorias dos resultados de supressão viral, embora as proporções observadas estejam abaixo da expectativa da terceira meta global.Background: Changes in guidelines for peoples living with HIV (PLHIV) in recent years require an assessment of the first-line antiretroviral therapy (ART) effectiveness in the real-world scenario. Objective: to evaluate the viral suppression in the first year of antiretroviral treatment with dolutegravir (DTG) vs. efavirenz (EFV), and verify associated factors. Methods: This was a historical cohort study with PLHIV ≥18 years old, who started ART between 2015 and 2017 in Minas Gerais state (n=2.599). Information about age, gender, residence, viral load (VL), CD4⁺ cell count and antiretroviral dispensing were extracted from two Unified Health System databases. Viral suppression (VL <50 copies/mL) was analyzed in intention-to-treat (ITT) compared with per-protocol analysis and with VL <1.000 copies/mL. The time until the first recorded of VL <50 copies/mL was estimated by the Kaplan-Meier method. Cox proportional hazards model (HR) to determine predictors of viral suppression after six months initiating ART. Logistic regressions were used to estimate adjusted odds ratios (aORs) in the first 12 months of treatment. Statistical significance was defined a level of 5% and 95% confidence interval (95%CI). Results: Selected 2.599 individuals, 34% starting treatment with DTG and 66% with EFV. There was a predominance of men (77.5%), median age of 34 years old, baseline CD4⁺ 322 cell/mmᵌ and VL 4.7 (log) copies/mL. The changes in the ART occurred in 5% of PLHIV that began with DTG and 9.2% with EFV-based regimens (p<.0001). In ITT, higher proportion of viral suppression was observed for DTG compared to EFV (76.7% vs. 58.1%), even considering VL <1.000 copies (p<0.0001). DTG-based regime had less time until the first recorded of VL <50 copies/mL after six months initiating ART (HR=1.29; 95%CI 1.15 – 1.43) and higher odds in the first 12 months (aORs=2.44; 95%CI 2.01 – 2.95). ART initiation <120 days, CD4⁺ T-cell count ≥200 cell/μl and baseline VL <100,000 copies/mL also had higher odds of viral suppression. In protocol analysis was observed largest proportion of viral suppression and ART groups had the same time interval until the outcome. Conclusion: After the introduction of DTG, the viral suppression results were improved, though observed proportions was lower than the expected according to the third global target.porUniversidade Federal de Minas GeraisPrograma de Pós-Graduação em Ciências da Saúde - Infectologia e Medicina TropicalUFMGBrasilMEDICINA - FACULDADE DE MEDICINAHIV-1AntirretroviraisEfetividadeCarga ViralEstudos de CoortesHIV-1AntirretroviraisEfetividadeCarga ViralSupressão viral do HIV nos 12 primeiros meses de terapia antirretroviral: análise comparativa de esquemas estruturados com dolutegravir ou efavirenz, Minas Gerais 2015-2017info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMGORIGINALenvio_repositório.pdfenvio_repositório.pdfDissertação_Mestrado_Gabriella_Jomara_Silvaapplication/pdf1694119https://repositorio.ufmg.br/bitstream/1843/37853/1/envio_reposit%c3%b3rio.pdfaa1267fb975551cd14bf0a8a651880eeMD51LICENSElicense.txtlicense.txttext/plain; charset=utf-82118https://repositorio.ufmg.br/bitstream/1843/37853/2/license.txtcda590c95a0b51b4d15f60c9642ca272MD521843/378532021-08-31 12:56:03.084oai:repositorio.ufmg.br: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ório InstitucionalPUBhttps://repositorio.ufmg.br/oaiopendoar:2021-08-31T15:56:03Repositório Institucional da UFMG - Universidade Federal de Minas Gerais (UFMG)false
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