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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 Infect Dis. 2021 Jan 21; 21(1):90.BI

Abstract

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).

Authors+Show Affiliations

Institute for Global Health, University College London, London, UK. j.surey@ucl.ac.uk. Faculty of Medicine, Universidad Autónoma Madrid, Madrid, Spain. j.surey@ucl.ac.uk.Usher Institute, University of Edinburgh, Edinburgh, UK.Institute for Global Health, University College London, London, UK. Department of Infectious Disease, Faculty of Medicine, Imperial College London, London, W2 1NY, UK.UCL-TB and UCL Respiratory, UCL, London, Royal Free London National Health Service Foundation Trust, London, UK.National Infection Service, Public Health, England, UK. Department of Infectious Disease Epidemiology, Imperial College School of Public Health, MRC Centre for Global Infectious Disease Analysis and NIHR Health Protection Research Unit in Modelling Methodology, London, UK.National Infection Service, Public Health, England, UK.Clinical Sciences Department. School of Medicine, University of Barcelona and Internal Medicine Department, Parc Sanitari Sant Joan de Déu. Sant Boi, Barcelona, Spain.Institute for Global Health, University College London, London, UK.Institute for Global Health, University College London, London, UK.Institute for Global Health, University College London, London, UK.Institute for Global Health, University College London, London, UK.Blizard Institute, Queen Mary University of London, London, UK. Department of Respiratory Medicine, Barts Health NHS Trust, London, UK.Institute for Global Health, University College London, London, UK.

Pub Type(s)

Equivalence Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

33478428

Citation

Surey, J, et al. "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, no. 1, 2021, p. 90.
Surey J, Stagg HR, Yates TA, et al. 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 Infect Dis. 2021;21(1):90.
Surey, J., Stagg, H. R., Yates, T. A., Lipman, M., White, P. J., Charlett, A., Muñoz, L., Gosce, 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, 21(1), 90. https://doi.org/10.1186/s12879-021-05766-9
Surey J, et al. 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 Infect Dis. 2021 Jan 21;21(1):90. PubMed PMID: 33478428.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Surey,J, AU - Stagg,H R, AU - Yates,T A, AU - Lipman,M, AU - White,P J, AU - Charlett,A, AU - Muñoz,L, AU - Gosce,L, AU - Rangaka,M X, AU - Francis,M, AU - Hack,V, AU - Kunst,H, AU - Abubakar,I, Y1 - 2021/01/21/ PY - 2020/10/15/received PY - 2021/01/05/accepted PY - 2021/1/22/entrez PY - 2021/1/23/pubmed PY - 2021/2/7/medline KW - Latent tuberculosis treatment KW - Randomised controlled trial KW - Rifapentine KW - Tuberculosis SP - 90 EP - 90 JF - BMC infectious diseases JO - BMC Infect Dis VL - 21 IS - 1 N2 - 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). SN - 1471-2334 UR - https://www.unboundmedicine.com/medline/citation/33478428/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_ L2 - https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-05766-9 DB - PRIME DP - Unbound Medicine ER -