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Adverse events reported during weekly isoniazid-rifapentine (3HP) tuberculosis preventive treatment among people living with HIV in Uganda.
Kadota, Jillian L; Musinguzi, Allan; Aschmann, Hélène E; Akello, Lydia; Welishe, Fred; Nakimuli, Jane; Berger, Christopher A; Kiwanuka, Noah; Phillips, Patrick Pj; Katamba, Achilles; Dowdy, David W; Cattamanchi, Adithya; Semitala, Fred C.
Afiliação
  • Kadota JL; Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco CA USA.
  • Musinguzi A; Center for Tuberculosis, University of California San Francisco, San Francisco CA USA.
  • Aschmann HE; Infectious Diseases Research Collaboration, Kampala, Uganda.
  • Akello L; Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco CA USA.
  • Welishe F; Center for Tuberculosis, University of California San Francisco, San Francisco CA USA.
  • Nakimuli J; Infectious Diseases Research Collaboration, Kampala, Uganda.
  • Berger CA; Infectious Diseases Research Collaboration, Kampala, Uganda.
  • Kiwanuka N; Infectious Diseases Research Collaboration, Kampala, Uganda.
  • Phillips PP; Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco CA USA.
  • Katamba A; Center for Tuberculosis, University of California San Francisco, San Francisco CA USA.
  • Dowdy DW; Department of Epidemiology and Biostatistics, School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda.
  • Cattamanchi A; Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco CA USA.
  • Semitala FC; Center for Tuberculosis, University of California San Francisco, San Francisco CA USA.
medRxiv ; 2024 Aug 09.
Article em En | MEDLINE | ID: mdl-39148841
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 (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.

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article