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https://www.arca.fiocruz.br/handle/icict/59349
SEX DIFFERENCES AND ADVERSE EVENTS OF ANTIRETROVIRALS IN PEOPLE LIVING WITH HIV/AIDS: A SYSTEMATIC REVIEW AND META-ANALYSIS PROTOCOL
HIV infections
Adverse events
Clinical pharmacology
Health policy
Antirretrovirais / efeitos adversos
Viés
Infecções por HIV / tratamento farmacológico
Metanálise como Assunto
Caracteres Sexuais
Revisões Sistemáticas como Assunto
Author
Oliveira, Jardel Corrêa de
Alves, Maíra Ramos
Lopes, Luis Phillipe Nagem
Iwami, Rodrigo Suguimoto
Motter, Fabiane Raquel
Bergamaschi, Cristiane de Cássia
Silva, Marcus Tolentino
Scalco, Diogo Luis
Lucio, Donavan de Souza
Mazzei, Lauren Giustti
Derech, Rodrigo D’Agostini
Pereira, Tiago Veiga
Barreto, Jorge Otávio Maia
Lopes, Luciane Cruz
Alves, Maíra Ramos
Lopes, Luis Phillipe Nagem
Iwami, Rodrigo Suguimoto
Motter, Fabiane Raquel
Bergamaschi, Cristiane de Cássia
Silva, Marcus Tolentino
Scalco, Diogo Luis
Lucio, Donavan de Souza
Mazzei, Lauren Giustti
Derech, Rodrigo D’Agostini
Pereira, Tiago Veiga
Barreto, Jorge Otávio Maia
Lopes, Luciane Cruz
Affilliation
University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brasil / Florianópolis Family Medicine Residency Program. Family Physician. Florianópolis, SC, Brazil.
University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brasil.
Federal University of Rio de Janeiro. Pharmacy Undergraduate Course. Rio de Janeiro, RJ, Brazil.
University of Sorocaba. Nursing Undergraduate Course. Sorocaba, SP, Brazil.
University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brazil.
University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brazil.
University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brazil.
Federal University of São Carlos. Department of Economics. Sorocaba, SP, Brazil.
Florianópolis Family Medicine Residency Program. Family Physician. Florianópolis, SC, Brazil.
Florianópolis Family Medicine Residency Program. Family Physician. Florianópolis, SC, Brazil.
University of Sorocaba. Department of Physiotherapy. Sorocaba, SP, Brazil.
Municipal Health Department of the Florianópolis City Hall. Florianópolis, SC, Brazil.
University of Leicester. Department of Health Sciences. Leicester, United Kingdom / University of Toronto. St. Michael’s Hospital. Applied Health Research Centre. Toronto, ON, Canada.
Fundação Oswaldo Cruz. Fiocruz Brasília. Brasília, DF, Brasil.
University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brazil.
University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brasil.
Federal University of Rio de Janeiro. Pharmacy Undergraduate Course. Rio de Janeiro, RJ, Brazil.
University of Sorocaba. Nursing Undergraduate Course. Sorocaba, SP, Brazil.
University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brazil.
University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brazil.
University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brazil.
Federal University of São Carlos. Department of Economics. Sorocaba, SP, Brazil.
Florianópolis Family Medicine Residency Program. Family Physician. Florianópolis, SC, Brazil.
Florianópolis Family Medicine Residency Program. Family Physician. Florianópolis, SC, Brazil.
University of Sorocaba. Department of Physiotherapy. Sorocaba, SP, Brazil.
Municipal Health Department of the Florianópolis City Hall. Florianópolis, SC, Brazil.
University of Leicester. Department of Health Sciences. Leicester, United Kingdom / University of Toronto. St. Michael’s Hospital. Applied Health Research Centre. Toronto, ON, Canada.
Fundação Oswaldo Cruz. Fiocruz Brasília. Brasília, DF, Brasil.
University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brazil.
Abstract
Introduction: Antiretroviral therapy (ART) for HIV/AIDS is associated with adverse events (AEs). However, little is known about the differences in the risk of AEs between women and men living with HIV/AIDS. This study aims to determine (1) whether there are sex differences in the risk of AEs in people with HIV/AIDS treated with ART and (2) the prevalence of AEs to the reproductive system and bone mineral density in women. Methods and analysis: This systematic review (SR) will include randomised trials evaluating ART in people living with HIV/AIDS with at least 12 weeks of duration follow-up. Searches will be conducted in Medline, Embase, Cochrane Library, Epistemonikos, Lilacs, trial registries and grey literature databases, without restriction on publication status, year of publication and language. The primary outcome will be the risk of ART discontinuation or drop-outs/withdrawals of ART due to AEs and the number of any treatment-emergent AE. The secondary outcomes are the incidence of serious clinic or laboratory (grade 3 and/or 4) treatment-emergent AEs, hospitalisation, death and AEs specific to the reproductive system and bone mineral density (osteoporosis, osteopenia and fractures) of women. Selection, data extraction and quality assessment will be performed by pairs of reviewers. Cochrane collaboration tools will be used to assess the risk of bias. If appropriate, a meta-analysis will be conducted to synthesise results. The overall quality of the evidence for each outcome will be determined by the Grades of Recommendation, Assessment, Development and Evaluation. Ethics and dissemination: The results of this SR will
assist the formulation of public policies aimed at the management and monitoring of AEs of ART in people living with HIV/AIDS. A deliberative dialogue will be scheduled
with the Department of Chronic Conditions and Sexually Transmitted Infections of Brazil’s Ministry of Health to align the project with policymakers’ interests.
Keywords
Acquired Immunodeficiency SyndromeHIV infections
Adverse events
Clinical pharmacology
Health policy
DeCS
Síndrome de Imunodeficiência AdquiridaAntirretrovirais / efeitos adversos
Viés
Infecções por HIV / tratamento farmacológico
Metanálise como Assunto
Caracteres Sexuais
Revisões Sistemáticas como Assunto
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