PDF(Pubmed)
Abstract：
OBJECTIVE: There is limited information regarding the incidence of treatment-related adverse events (AE) following antiretroviral therapy (ART) in women. So, this review aimed to describe the incidence of AE of ART in women living with HIV/AIDS.
METHODS: Systematic review and meta-analysis.
METHODS: Medline, Embase, Cochrane Library, Epistemonikos, Lilacs and Who Index, from inception to 9 April 2023.
METHODS: We included randomised controlled trials with at least 12 weeks of follow-up and evaluated AE of ART in women at any age living with HIV/AIDS, without restrictions on status, year or language of publication. We excluded post hoc or secondary analyses and open-label extensions without comparator, and trials involving pregnant or breastfeeding women or with a focus on coinfection with tuberculosis, hepatitis B or C. The primary outcomes were the incidence rate of participants with any clinical and/or laboratory AE related or not to ART and treatment discontinuation.
METHODS: Two independent reviewers extracted data and assessed the risk of bias using Cochrane\'s risk of bias tool 2. We used Bayesian random-effects meta-analysis to summarise event rates. Results were presented as event rates per 1000 person-years (95% credibility intervals, 95% CrI). The pooled incidence rate per 1000 person-years adjusted for duration and loss to follow-up was estimated. We assessed the certainty of the evidence using Grading of Recommendations, Assessment, Development and Evaluation.
RESULTS: A total of 24 339 studies were identified for screening, of which 10 studies (2871 women) met the eligibility criteria, with 11 different antiretrovirals (ARVs) regimens. Seven studies included exclusively women, while in the remaining three, the proportion of women ranged from 11% to 46%. Nine studies received industry funding. The pooled analysis showed a mean incidence rate of ART-related clinical and laboratory AE of 341.60 events per 1000 person-years (95% CrI 133.60-862.70), treatment discontinuation of 20.78 events per 1000 person-years (95% CrI 5.58-57.31) and ART-related discontinuation of 4.31 per 1000 person-years (95% CrI 0.13-54.72). Summary estimates were subject to significant uncertainty due to the limited number of studies and sparse data. The certainty of the evidence was graded as very low for all outcomes assessed.
CONCLUSIONS: Existing randomised trials do not provide sufficient evidence on the incidence rates of safety outcomes from antiretroviral treatment in women living with HIV/AIDS. Large comparative studies in well-characterised populations are needed to provide a more comprehensive landscape of the safety profile of these ARV therapies in women with HIV/AIDS.
UNASSIGNED: CRD42021251051.
METHODS: Systematic review and meta-analysis.
METHODS: Medline, Embase, Cochrane Library, Epistemonikos, Lilacs and Who Index, from inception to 9 April 2023.
METHODS: We included randomised controlled trials with at least 12 weeks of follow-up and evaluated AE of ART in women at any age living with HIV/AIDS, without restrictions on status, year or language of publication. We excluded post hoc or secondary analyses and open-label extensions without comparator, and trials involving pregnant or breastfeeding women or with a focus on coinfection with tuberculosis, hepatitis B or C. The primary outcomes were the incidence rate of participants with any clinical and/or laboratory AE related or not to ART and treatment discontinuation.
METHODS: Two independent reviewers extracted data and assessed the risk of bias using Cochrane\'s risk of bias tool 2. We used Bayesian random-effects meta-analysis to summarise event rates. Results were presented as event rates per 1000 person-years (95% credibility intervals, 95% CrI). The pooled incidence rate per 1000 person-years adjusted for duration and loss to follow-up was estimated. We assessed the certainty of the evidence using Grading of Recommendations, Assessment, Development and Evaluation.
RESULTS: A total of 24 339 studies were identified for screening, of which 10 studies (2871 women) met the eligibility criteria, with 11 different antiretrovirals (ARVs) regimens. Seven studies included exclusively women, while in the remaining three, the proportion of women ranged from 11% to 46%. Nine studies received industry funding. The pooled analysis showed a mean incidence rate of ART-related clinical and laboratory AE of 341.60 events per 1000 person-years (95% CrI 133.60-862.70), treatment discontinuation of 20.78 events per 1000 person-years (95% CrI 5.58-57.31) and ART-related discontinuation of 4.31 per 1000 person-years (95% CrI 0.13-54.72). Summary estimates were subject to significant uncertainty due to the limited number of studies and sparse data. The certainty of the evidence was graded as very low for all outcomes assessed.
CONCLUSIONS: Existing randomised trials do not provide sufficient evidence on the incidence rates of safety outcomes from antiretroviral treatment in women living with HIV/AIDS. Large comparative studies in well-characterised populations are needed to provide a more comprehensive landscape of the safety profile of these ARV therapies in women with HIV/AIDS.
UNASSIGNED: CRD42021251051.
摘要：
目的：关于女性抗逆转录病毒治疗（ART）后治疗相关不良事件（AE）发生率的信息有限。所以,本综述旨在描述感染HIV/AIDS的女性ART不良事件的发生率.
方法：系统评价和荟萃分析。
方法：Medline，Embase,科克伦图书馆,认识论，丁香花和谁索引，从成立到2023年4月9日。
方法：我们纳入了至少12周随访的随机对照试验，并评估了任何年龄感染艾滋病毒/艾滋病的女性的ART不良事件。没有地位限制，年份或出版语言。我们排除了事后或二次分析以及没有比较器的开放标签扩展，以及涉及孕妇或哺乳期妇女或重点关注结核病合并感染的试验，乙肝或丙肝的主要结局是任何临床和/或实验室AE相关或不相关的参与者的发病率ART和治疗中断.
方法：两名独立的审阅者提取数据并使用Cochrane的偏倚风险工具2评估偏倚风险。我们使用贝叶斯随机效应荟萃分析来总结事件发生率。结果表示为每1000人年的事件发生率(95%可信度间隔，95%CrI)。估计了每1000人年的合并发病率，并根据持续时间和随访损失进行了调整。我们使用建议分级评估证据的确定性，评估,发展和评价。
结果：共有24339项研究被确定用于筛查，其中10项研究(2871名女性)符合资格标准，11种不同的抗逆转录病毒药物（ARV）方案。七项研究仅包括女性，而在剩下的三个中，女性比例从11%到46%不等。九项研究获得了行业资助。汇总分析显示，ART相关临床和实验室不良事件的平均发生率为每1000人年341.60例（95％CrI133.60-862.70），治疗终止事件为20.78/1000人年(95%CrI5.58-57.31),ART相关终止事件为4.31/1000人年(95%CrI0.13-54.72).由于研究数量有限和数据稀疏，汇总估计存在很大的不确定性。对于所有评估的结果，证据的确定性被评为非常低。
结论：现有的随机试验没有提供足够的证据证明抗逆转录病毒治疗在HIV/AIDS女性患者中的安全性结局发生率。需要在特征明确的人群中进行大量比较研究，以更全面地了解这些抗逆转录病毒疗法在艾滋病毒/艾滋病女性中的安全性。
■CRD42021251051。
方法：系统评价和荟萃分析。
方法：Medline，Embase,科克伦图书馆,认识论，丁香花和谁索引，从成立到2023年4月9日。
方法：我们纳入了至少12周随访的随机对照试验，并评估了任何年龄感染艾滋病毒/艾滋病的女性的ART不良事件。没有地位限制，年份或出版语言。我们排除了事后或二次分析以及没有比较器的开放标签扩展，以及涉及孕妇或哺乳期妇女或重点关注结核病合并感染的试验，乙肝或丙肝的主要结局是任何临床和/或实验室AE相关或不相关的参与者的发病率ART和治疗中断.
方法：两名独立的审阅者提取数据并使用Cochrane的偏倚风险工具2评估偏倚风险。我们使用贝叶斯随机效应荟萃分析来总结事件发生率。结果表示为每1000人年的事件发生率(95%可信度间隔，95%CrI)。估计了每1000人年的合并发病率，并根据持续时间和随访损失进行了调整。我们使用建议分级评估证据的确定性，评估,发展和评价。
结果：共有24339项研究被确定用于筛查，其中10项研究(2871名女性)符合资格标准，11种不同的抗逆转录病毒药物（ARV）方案。七项研究仅包括女性，而在剩下的三个中，女性比例从11%到46%不等。九项研究获得了行业资助。汇总分析显示，ART相关临床和实验室不良事件的平均发生率为每1000人年341.60例（95％CrI133.60-862.70），治疗终止事件为20.78/1000人年(95%CrI5.58-57.31),ART相关终止事件为4.31/1000人年(95%CrI0.13-54.72).由于研究数量有限和数据稀疏，汇总估计存在很大的不确定性。对于所有评估的结果，证据的确定性被评为非常低。
结论：现有的随机试验没有提供足够的证据证明抗逆转录病毒治疗在HIV/AIDS女性患者中的安全性结局发生率。需要在特征明确的人群中进行大量比较研究，以更全面地了解这些抗逆转录病毒疗法在艾滋病毒/艾滋病女性中的安全性。
■CRD42021251051。
