PMID- 35210346 OWN - NLM STAT- MEDLINE DCOM- 20220407 LR - 20220530 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 12 IP - 2 DP - 2022 Feb 24 TI - Sex differences and adverse events of antiretrovirals in people living with HIV/AIDS: a systematic review and meta-analysis protocol. PG - e057094 LID - 10.1136/bmjopen-2021-057094 [doi] LID - e057094 AB - 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. PROSPERO REGISTRATION NUMBER: CRD42021251051. CI - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - de Oliveira, Jardel Correa AU - de Oliveira JC AD - Graduate Course in Pharmaceutical Sciences, University of Sorocaba, Sorocaba, Sao Paulo, Brazil. AD - Family Physician, Florianopolis Family Medicine Residency Program, Florianopolis, Santa Catarina, Brazil. FAU - Alves, Maira Ramos AU - Alves MR AD - Graduate Course in Pharmaceutical Sciences, University of Sorocaba, Sorocaba, Sao Paulo, Brazil. FAU - Lopes, Luis Phillipe Nagem AU - Lopes LPN AD - Pharmacy Undergraduate Course, Federal University of Rio de Janeiro, Rio de Janeiro, Rio de Janeiro, Brazil. FAU - Iwami, Rodrigo Suguimoto AU - Iwami RS AD - Nursing Undergraduate Course, University of Sorocaba, Sorocaba, Sao Paulo, Brazil. FAU - Motter, Fabiane Raquel AU - Motter FR AUID- ORCID: 0000-0003-0796-1130 AD - Graduate Course in Pharmaceutical Sciences, University of Sorocaba, Sorocaba, Sao Paulo, Brazil. FAU - Bergamaschi, Cristiane de Cassia AU - Bergamaschi CC AD - Graduate Course in Pharmaceutical Sciences, University of Sorocaba, Sorocaba, Sao Paulo, Brazil. FAU - Silva, Marcus Tolentino AU - Silva MT AUID- ORCID: 0000-0002-7186-9075 AD - Graduate Course in Pharmaceutical Sciences, University of Sorocaba, Sorocaba, Sao Paulo, Brazil. FAU - Itria, Alexander AU - Itria A AD - Department of Economics, Federal University of Sao Carlos, Sorocaba, Sao Paulo, Brazil. FAU - Scalco, Diogo Luis AU - Scalco DL AD - Family Physician, Florianopolis Family Medicine Residency Program, Florianopolis, Santa Catarina, Brazil. FAU - Lucio, Donavan de Souza AU - Lucio DS AUID- ORCID: 0000-0002-8434-9781 AD - Family Physician, Florianopolis Family Medicine Residency Program, Florianopolis, Santa Catarina, Brazil. FAU - Mazzei, Lauren Giustti AU - Mazzei LG AD - Department of Physiotherapy, University of Sorocaba, Sorocaba, Sao Paulo, Brazil. FAU - Derech, Rodrigo D'Agostini AU - Derech RD AD - Geriatrician, Municipal Health Department of the Florianopolis City Hall, Florianopolis, Santa Catarina, Brazil. FAU - Pereira, Tiago Veiga AU - Pereira TV AD - Department of Health Sciences, University of Leicester, Leicester, Leicestershire, UK. FAU - Barreto, Jorge Otavio Maia AU - Barreto JOM AD - Fiocruz Brasilia, Oswaldo Cruz Foundation, Brasilia, Federal District, Brazil. FAU - Lopes, Luciane Cruz AU - Lopes LC AUID- ORCID: 0000-0002-3684-3275 AD - Graduate Course in Pharmaceutical Sciences, University of Sorocaba, Sorocaba, Sao Paulo, Brazil luslopesbr@gmail.com. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220224 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 0 (Anti-Retroviral Agents) SB - IM MH - *Acquired Immunodeficiency Syndrome MH - Anti-Retroviral Agents/adverse effects MH - Bias MH - Female MH - *HIV Infections/drug therapy MH - Humans MH - Male MH - Meta-Analysis as Topic MH - Sex Characteristics MH - Systematic Reviews as Topic PMC - PMC8883265 OTO - NOTNLM OT - HIV & AIDS OT - adverse events OT - clinical pharmacology OT - health policy COIS- Competing interests: None declared. EDAT- 2022/02/26 06:00 MHDA- 2022/04/08 06:00 PMCR- 2022/02/23 CRDT- 2022/02/25 05:33 PHST- 2022/02/25 05:33 [entrez] PHST- 2022/02/26 06:00 [pubmed] PHST- 2022/04/08 06:00 [medline] PHST- 2022/02/23 00:00 [pmc-release] AID - bmjopen-2021-057094 [pii] AID - 10.1136/bmjopen-2021-057094 [doi] PST - epublish SO - BMJ Open. 2022 Feb 24;12(2):e057094. doi: 10.1136/bmjopen-2021-057094.