دورية أكاديمية
Adverse events reported during weekly isoniazid-rifapentine (3HP) tuberculosis preventive treatment among people living with HIV in Uganda.
| العنوان: | Adverse events reported during weekly isoniazid-rifapentine (3HP) tuberculosis preventive treatment among people living with HIV in Uganda. |
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| المؤلفون: | Kadota JL; Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco CA USA.; Center for Tuberculosis, University of California San Francisco, San Francisco CA USA., Musinguzi A; Infectious Diseases Research Collaboration, Kampala, Uganda., Aschmann HE; Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco CA USA.; Center for Tuberculosis, University of California San Francisco, San Francisco CA USA., Akello L; Infectious Diseases Research Collaboration, Kampala, Uganda., Welishe F; Infectious Diseases Research Collaboration, Kampala, Uganda., Nakimuli J; Infectious Diseases Research Collaboration, Kampala, Uganda., Berger CA; Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco CA USA.; Center for Tuberculosis, University of California San Francisco, San Francisco CA USA., Kiwanuka N; Department of Epidemiology and Biostatistics, School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda., Phillips PP; Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco CA USA.; Center for Tuberculosis, University of California San Francisco, San Francisco CA USA., Katamba A; Clinical Epidemiology & Biostatistics Unit, Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.; Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda., Dowdy DW; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Cattamanchi A; Center for Tuberculosis, University of California San Francisco, San Francisco CA USA.; Division of Pulmonary Diseases and Critical Care Medicine, University of California Irvine, Orange CA USA., Semitala FC; Infectious Diseases Research Collaboration, Kampala, Uganda.; Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.; Makerere University Joint AIDS Program, Kampala, Uganda. |
| المصدر: | MedRxiv : the preprint server for health sciences [medRxiv] 2024 Aug 09. Date of Electronic Publication: 2024 Aug 09. |
| نوع المنشور: | Journal Article; Preprint |
| اللغة: | English |
| بيانات الدورية: | Country of Publication: United States NLM ID: 101767986 Publication Model: Electronic Cited Medium: Internet NLM ISO Abbreviation: medRxiv Subsets: PubMed not MEDLINE |
| مستخلص: | 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 (AE) could differ in routine settings. Real-world data on AE type, frequency, and timing is crucial for health systems considering 3HP programmatic scale-up. Methods: We reviewed AEs among people living with HIV (PLHIV) 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 lab tests, diagnoses made, medications prescribed, and treatment interruptions. Results: Among 1655 PLHIV treated between July 2020-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 PLHIV 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. |
| معلومات مُعتمدة: | R01 HL144406 United States HL NHLBI NIH HHS |
| تواريخ الأحداث: | Date Created: 20240816 Latest Revision: 20240819 |
| رمز التحديث: | 20240819 |
| مُعرف محوري في PubMed: | PMC11326332 |
| DOI: | 10.1101/2024.08.08.24311632 |
| PMID: | 39148841 |
| قاعدة البيانات: | MEDLINE |
| DOI: | 10.1101/2024.08.08.24311632 |
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