An open label, randomised controlled trial of rifapentine versus rifampicin based short course regimens for the treatment of latent tuberculosis in England: the HALT LTBI pilot study

Autor: Tom A Yates, Molebogeng X Rangaka, Marie Francis, Andre Charlett, Peter J White, V. Hack, Lara Goscé, Helen R. Stagg, Heinke Kunst, Laura Muñoz, Ibrahim Abubakar, Julian Surey, Marc Lipman
Přispěvatelé: National Institute for Health Research, Medical Research Council (MRC)
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Male
Antitubercular Agents
Pilot Projects
Self Administration
030204 cardiovascular system & hematology
law.invention
0302 clinical medicine
Randomized controlled trial
law
1108 Medical Microbiology
London
030212 general & internal medicine
Randomised controlled trial
Latent tuberculosis
Isoniazid
Middle Aged
Infectious Diseases
Treatment Outcome
Drug Therapy
Combination
Female
Rifampin
Life Sciences & Biomedicine
Research Article
medicine.drug
0605 Microbiology
Adult
medicine.medical_specialty
Tuberculosis
Adolescent
Microbiology
Drug Administration Schedule
Rifapentine
lcsh:Infectious and parasitic diseases
03 medical and health sciences
Young Adult
Latent Tuberculosis
Latent tuberculosis treatment
Internal medicine
medicine
Humans
lcsh:RC109-216
Adverse effect
Science & Technology
business.industry
1103 Clinical Sciences
medicine.disease
Regimen
business
Rifampicin
Zdroj: BMC Infectious Diseases, Vol 21, Iss 1, Pp 1-8 (2021)
Surey, J, Stagg, H R, Yates, T A, Lipman, M, White, P J, Charlett, A, Muñoz, L, Goscé, L, Rangaka, M X, Francis, M, Hack, V, Kunst, H & Abubakar, I 2021, ' An open label, randomised controlled trial of rifapentine versus rifampicin based short course regimens for the treatment of latent tuberculosis in England : the HALT LTBI pilot study ', BMC Infectious Diseases, vol. 21, 90 . https://doi.org/10.1186/s12879-021-05766-9
BMC INFECTIOUS DISEASES
r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
instname
r-FSJD: Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
Fundació Sant Joan de Déu
BMC Infectious Diseases
ISSN: 1471-2334
DOI: 10.1186/s12879-021-05766-9
Popis: Background Ending the global tuberculosis (TB) epidemic requires a focus on treating individuals with latent TB infection (LTBI) to prevent future cases. Promising trials of shorter regimens have shown them to be effective as preventative TB treatment, however there is a paucity of data on self-administered treatment completion rates. This pilot trial assessed treatment completion, adherence, safety and the feasibility of treating LTBI in the UK using a weekly rifapentine and isoniazid regimen versus daily rifampicin and isoniazid, both self-administered for 12 weeks. Methods An open label, randomised, multi-site pilot trial was conducted in London, UK, between March 2015 and January 2017. Adults between 16 and 65 years with LTBI at two TB clinics who were eligible for and agreed to preventative therapy were consented and randomised 1:1 to receive either a weekly combination of rifapentine/isoniazid (‘intervention’) or a daily combination of rifampicin/isoniazid (‘standard’), with both regimens taken for twelve weeks; treatment was self-administered in both arms. The primary outcome, completion of treatment, was self-reported, defined as taking more than 90% of prescribed doses and corroborated by pill counts and urine testing. Adverse events were recorded. Results Fifty-two patients were successfully enrolled. In the intervention arm 21 of 27 patients completed treatment (77.8, 95% confidence interval [CI] 57.7–91.4), compared with 19 of 25 (76.0%, CI 54.9–90.6) in the standard of care arm. There was a similar adverse effect profile between the two arms. Conclusion In this pilot trial, treatment completion was comparable between the weekly rifapentine/isoniazid and the daily rifampicin/isoniazid regimens. Additionally, the adverse event profile was similar between the two arms. We conclude that it is safe and feasible to undertake a fully powered trial to determine whether self-administered weekly treatment is superior/non-inferior compared to current treatment. Trial registration The trial was funded by the NIHR, UK and registered with ISRCTN (26/02/2013-No.04379941).
Databáze: OpenAIRE
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