Adverse Events Reported During Weekly Isoniazid-Rifapentine (3HP) Tuberculosis Preventive Treatment Among People With Human Immunodeficiency Virus in Uganda.

IF 3.8 4区 医学 Q2 IMMUNOLOGY
Open Forum Infectious Diseases Pub Date : 2024-11-14 eCollection Date: 2024-11-01 DOI:10.1093/ofid/ofae667
Jillian L Kadota, Allan Musinguzi, Hélène E Aschmann, Lydia Akello, Fred Welishe, Jane Nakimuli, Christopher A Berger, Noah Kiwanuka, Patrick P J Phillips, Achilles Katamba, David W Dowdy, Adithya Cattamanchi, Fred C Semitala
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引用次数: 0

Abstract

Background: Short-course tuberculosis (TB) prevention regimens, including 12 weeks of isoniazid and rifapentine (3HP), are increasingly used in high-TB-burden countries. Despite established safety and tolerability in efficacy trials, 3HP-related adverse events (AEs) could differ in routine settings. Real-world data on AE type, frequency, and timing are crucial for health systems considering 3HP programmatic scale-up.

Methods: We reviewed AEs among people with human immunodeficiency virus (HIV) participating in a pragmatic implementation trial of facilitated 3HP taken by directly observed therapy (DOT) or self-administered therapy (SAT) in Kampala, Uganda, and classified them using the Common Terminology Criteria for Adverse Events. We assessed AE timing and summarized related clinical actions including laboratory tests, diagnoses made, medications prescribed, and treatment interruptions.

Results: Among 1655 people with HIV treated between July 2020 and September 2022, 270 (16.3%) reported 451 events; main issues included general (7%), nervous system (6%), musculoskeletal (5%), gastrointestinal (5%), and dermatologic (3%) disorders. Most (61%) occurred within 6 weeks of initiating 3HP. Among those with events, 211 (78%) required further clinician evaluation, 202 (75%) required laboratory testing, 102 (38%) had medications prescribed, 40 (15%) had treatment paused, and 14 (5%) discontinued 3HP. Women, those multidimensionally impoverished, and DOT recipients were more likely to report an AE. SAT users and later enrollees were more likely to have 3HP interrupted or stopped due to an AE.

Conclusions: In a routine setting, 3HP was safe, with 16% of people with HIV reporting AEs and only 3% requiring temporary or permanent treatment interruption. These findings support 3HP expansion in routine HIV/AIDS care settings for TB prevention. Clinical Trials Registration. NCT03934931.

乌干达人类免疫缺陷病毒感染者每周接受异烟肼-利福喷丁(3HP)结核病预防治疗期间报告的不良事件。
背景:在结核病负担较重的国家,越来越多地使用短程结核病(TB)预防方案,包括使用 12 周的异烟肼和利福喷丁(3HP)。尽管在疗效试验中证实了3HP的安全性和耐受性,但与3HP相关的不良事件(AEs)在常规情况下可能会有所不同。有关不良反应类型、频率和时间的真实世界数据对于考虑扩大 3HP 项目规模的卫生系统至关重要:我们回顾了参与乌干达坎帕拉通过直接观察疗法(DOT)或自我管理疗法(SAT)促进 3HP 实施试验的人类免疫缺陷病毒(HIV)感染者的不良事件,并使用不良事件通用术语标准对其进行了分类。我们评估了不良事件发生的时间,并总结了相关的临床行动,包括实验室检查、诊断、处方药物和治疗中断:在 2020 年 7 月至 2022 年 9 月期间接受治疗的 1655 名艾滋病毒感染者中,有 270 人(16.3%)报告了 451 起不良事件;主要问题包括一般(7%)、神经系统(6%)、肌肉骨骼(5%)、胃肠道(5%)和皮肤病(3%)。大多数(61%)发生在开始使用 3HP 的 6 周内。在发生事件的患者中,211 人(78%)需要临床医生进一步评估,202 人(75%)需要进行实验室检测,102 人(38%)需要开药,40 人(15%)暂停治疗,14 人(5%)停用 3HP。女性、多方面贫困者和接受短期直接观察治疗者更有可能报告 AE。SAT使用者和后来加入者更有可能因AE而中断或停止3HP:在常规情况下,3HP 是安全的,16% 的 HIV 感染者报告了 AE,只有 3% 需要暂时或永久中断治疗。这些研究结果支持将3HP推广到常规HIV/AIDS治疗中,以预防结核病。临床试验注册。NCT03934931。
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来源期刊
Open Forum Infectious Diseases
Open Forum Infectious Diseases Medicine-Neurology (clinical)
CiteScore
6.70
自引率
4.80%
发文量
630
审稿时长
9 weeks
期刊介绍: Open Forum Infectious Diseases provides a global forum for the publication of clinical, translational, and basic research findings in a fully open access, online journal environment. The journal reflects the broad diversity of the field of infectious diseases, and focuses on the intersection of biomedical science and clinical practice, with a particular emphasis on knowledge that holds the potential to improve patient care in populations around the world. Fully peer-reviewed, OFID supports the international community of infectious diseases experts by providing a venue for articles that further the understanding of all aspects of infectious diseases.
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