Wang Chengliang, Zhang Yan, Tang Xiting, Zhang Guoping, Chen Li
People's Hospital of Ganzi Tibetan Autonomous Prefecture, Kangding, Sichuan, China.
Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China.
Front Pharmacol. 2024 Dec 4;15:1439781. doi: 10.3389/fphar.2024.1439781. eCollection 2024.
This study aims to evaluate and understand the safety profile of Genvoya by mining and analyzing adverse drug event (ADE, adverse drug event) reports from the FDA Adverse Event Reporting System (FAERS, FDA Adverse Event Reporting System) database, thus providing valuable reference information for individuals infected with HIV.
Data were obtained from the FAERS database, covering the period from the first quarter of 2015 to the fourth quarter of 2023, focusing on reports where Genvoya was the primary suspected drug. Data import and extraction were conducted using MySQL 8.0, with adverse events standardized according to the Medical Dictionary for Regulatory Activities (MedDRA, Medical Dictionary for Regulatory Activities) 27.0 terminology. Potential adverse event signals were identified through disproportionality analysis, including the reporting odds ratio (ROR, reporting odds ratio) method and the comprehensive standard by the Medicines and Healthcare products Regulatory Agency (MHRA, Medicines and Healthcare products Regulatory Agency) method. Statistical analyses and graphical representations were performed.
A total of 2, 376 adverse drug event reports related to Genvoya were analyzed. Reports from male patients accounted for 74.33%, while those from female patients accounted for 22.39%. Common adverse events included weight gain, drug interactions, and increased viral load. Additionally, new potential adverse reactions, such as fat redistribution, HIV-associated neurocognitive disorders, and meningoencephalitis, were identified. These reactions were not adequately described in the existing literature and drug labels.
Multiple adverse reactions were observed with the use of Genvoya. Clinicians should closely monitor these reactions and implement necessary preventive and intervention measures based on patient-specific conditions and treatment guidelines. Although this study has limitations, the analysis of FAERS database data has revealed various potential risks associated with Genvoya, providing important safety references for HIV treatment.
本研究旨在通过挖掘和分析美国食品药品监督管理局不良事件报告系统（FAERS）数据库中的药物不良事件（ADE）报告，评估并了解捷扶康（Genvoya）的安全性概况，从而为感染艾滋病毒的个体提供有价值的参考信息。
数据取自FAERS数据库，涵盖2015年第一季度至2023年第四季度，重点关注捷扶康为主要疑似药物的报告。使用MySQL 8.0进行数据导入和提取，不良事件根据《药物监管活动医学词典》（MedDRA）27.0术语进行标准化。通过不成比例分析识别潜在的不良事件信号，包括报告比值比（ROR）法和英国药品和保健品管理局（MHRA）的综合标准法。进行了统计分析和图形展示。
共分析了2376份与捷扶康相关的药物不良事件报告。男性患者报告占74.33%，女性患者报告占22.39%。常见不良事件包括体重增加、药物相互作用和病毒载量增加。此外，还识别出了新的潜在不良反应，如脂肪重新分布、HIV相关神经认知障碍和脑膜脑炎。这些反应在现有文献和药物标签中未得到充分描述。
使用捷扶康观察到多种不良反应。临床医生应密切监测这些反应，并根据患者具体情况和治疗指南采取必要的预防和干预措施。尽管本研究存在局限性，但对FAERS数据库数据的分析揭示了与捷扶康相关的各种潜在风险，为艾滋病毒治疗提供了重要的安全性参考。
