Graduate Course in Pharmaceutical Sciences, University of Sorocaba, Sorocaba, São Paulo, Brazil.
Family Physician, Florianópolis Family Medicine Residency Program, Florianópolis, Santa Catarina, Brazil.
BMJ Open. 2022 Feb 24;12(2):e057094. doi: 10.1136/bmjopen-2021-057094.
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.
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.
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.
CRD42021251051.
抗逆转录病毒疗法（ART）治疗艾滋病毒/艾滋病会引发不良反应（AE）。然而，人们对接受 ART 治疗的艾滋病毒/艾滋病患者中男女之间发生不良反应风险的差异知之甚少。本研究旨在确定：（1）接受 ART 治疗的艾滋病毒/艾滋病患者中是否存在与性别相关的不良反应风险差异；（2）女性生殖系统和骨密度不良反应的发生率。
本系统评价（SR）将纳入至少 12 周随访时间的评估 ART 治疗艾滋病毒感染者的随机试验。将在 Medline、Embase、Cochrane 图书馆、Epistemonikos、Lilacs、试验注册处和灰色文献数据库中进行检索，对发表状态、发表年份和语言均不设限制。主要结局将是由于不良反应而停止或中断 ART 治疗的风险，以及任何治疗后新发不良反应的数量。次要结局是严重临床或实验室（3 级和/或 4 级）治疗后新发不良反应、住院、死亡以及女性生殖系统和骨密度（骨质疏松症、骨量减少和骨折）特定不良反应的发生率。选择、数据提取和质量评估将由两名评审员共同进行。Cochrane 协作工具将用于评估偏倚风险。如果合适，将进行荟萃分析以综合结果。每个结局的证据总体质量将根据推荐、评估、开发和评估的等级来确定。
本 SR 的结果将有助于制定旨在管理和监测艾滋病毒感染者接受 ART 治疗的不良反应的公共政策。将与巴西卫生部慢性疾病和性传播感染司安排一次审议对话，使该项目与政策制定者的利益保持一致。
PROSPERO 注册号：CRD42021251051。
