| Author | Oliveira, Jardel Corrêa de | |
| Author | Alves, Maíra Ramos | |
| Author | Lopes, Luis Phillipe Nagem | |
| Author | Iwami, Rodrigo Suguimoto | |
| Author | Motter, Fabiane Raquel | |
| Author | Bergamaschi, Cristiane de Cássia | |
| Author | Silva, Marcus Tolentino | |
| Author | Scalco, Diogo Luis | |
| Author | Lucio, Donavan de Souza | |
| Author | Mazzei, Lauren Giustti | |
| Author | Derech, Rodrigo D’Agostini | |
| Author | Pereira, Tiago Veiga | |
| Author | Barreto, Jorge Otávio Maia | |
| Author | Lopes, Luciane Cruz | |
| Access date | 2023-07-02T22:39:05Z | |
| Available date | 2023-07-02T22:39:05Z | |
| Document date | 2022 | |
| Citation | OLIVEIRA, Jardel Corrêa de et al. Sex differences and adverse events of antiretrovirals in people living with HIV/AIDS: a systematic review and meta-analysis protocol. BMJ Open, [s.l.], v. 12, n. 2, e. 057094, 2022. | en_US |
| xmlui.metadata.dc.identifier.govdoc | CRD42021251051 | |
| ISSN | 2044-6055 | en_US |
| xmlui.metadata.dc.identifier.other | 35210346 | |
| xmlui.metadata.dc.identifier.other | PMC8883265 | |
| URI | https://www.arca.fiocruz.br/handle/icict/59349 | |
| Sponsorship | This research received funding from the São Paulo Research Foundation
(FAPESP), grant no. 2018/16893-8. | en_US |
| Language | eng | en_US |
| Publisher | BMJ Publishing Group Ltd. | en_US |
| Rights | open access | en_US |
| MeSH | Acquired Immunodeficiency Syndrome | en_US |
| MeSH | Anti-Retroviral Agents / adverse effects | en_US |
| MeSH | Bias | en_US |
| MeSH | Female | en_US |
| MeSH | HIV Infections / drug therapy | en_US |
| MeSH | Humans | en_US |
| MeSH | Male | en_US |
| MeSH | Meta-Analysis as Topic | en_US |
| MeSH | Sex Characteristics | en_US |
| MeSH | Systematic Reviews as Topic | en_US |
| Title | Sex differences and adverse events of antiretrovirals in people living with HIV/AIDS: a systematic review and meta-analysis protocol | en_US |
| Type | Article | en_US |
| DOI | 10.1136/bmjopen-2021-057094 | |
| 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. | en_US |
| Affilliation | University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brasil / Florianópolis Family Medicine Residency Program. Family Physician. Florianópolis, SC, Brazil. | en_US |
| Affilliation | University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brasil. | en_US |
| Affilliation | Federal University of Rio de Janeiro. Pharmacy Undergraduate Course. Rio de Janeiro, RJ, Brazil. | en_US |
| Affilliation | University of Sorocaba. Nursing Undergraduate Course. Sorocaba, SP, Brazil. | en_US |
| Affilliation | University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brazil. | en_US |
| Affilliation | University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brazil. | en_US |
| Affilliation | University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brazil. | en_US |
| Affilliation | Federal University of São Carlos. Department of Economics. Sorocaba, SP, Brazil. | en_US |
| Affilliation | Florianópolis Family Medicine Residency Program. Family Physician. Florianópolis, SC, Brazil. | en_US |
| Affilliation | Florianópolis Family Medicine Residency Program. Family Physician. Florianópolis, SC, Brazil. | en_US |
| Affilliation | University of Sorocaba. Department of Physiotherapy. Sorocaba, SP, Brazil. | en_US |
| Affilliation | Municipal Health Department of the Florianópolis City Hall. Florianópolis, SC, Brazil. | en_US |
| Affilliation | University of Leicester. Department of Health Sciences. Leicester, United Kingdom / University of Toronto. St. Michael’s Hospital. Applied Health Research Centre. Toronto, ON, Canada. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Fiocruz Brasília. Brasília, DF, Brasil. | en_US |
| Affilliation | University of Sorocaba. Graduate Course in Pharmaceutical Sciences. Sorocaba, SP, Brazil. | en_US |
| Subject | Acquired Immunodeficiency Syndrome | en_US |
| Subject | HIV infections | en_US |
| Subject | Adverse events | en_US |
| Subject | Clinical pharmacology | en_US |
| Subject | Health policy | en_US |
| DeCS | Síndrome de Imunodeficiência Adquirida | en_US |
| DeCS | Antirretrovirais / efeitos adversos | en_US |
| DeCS | Viés | en_US |
| DeCS | Infecções por HIV / tratamento farmacológico | en_US |
| DeCS | Metanálise como Assunto | en_US |
| DeCS | Caracteres Sexuais | en_US |
| DeCS | Revisões Sistemáticas como Assunto | en_US |
| e-ISSN | 2044-6055 | |
