eprintid: 10120483
rev_number: 30
eprint_status: archive
userid: 608
dir: disk0/10/12/04/83
datestamp: 2021-02-04 16:08:19
lastmod: 2022-08-30 15:44:35
status_changed: 2021-02-04 16:08:19
type: article
metadata_visibility: show
creators_name: Surey, J
creators_name: Stagg, HR
creators_name: Yates, TA
creators_name: Lipman, M
creators_name: White, PJ
creators_name: Charlett, A
creators_name: Muñoz, L
creators_name: Gosce, L
creators_name: Rangaka, MX
creators_name: Francis, M
creators_name: Hack, V
creators_name: Kunst, H
creators_name: Abubakar, I
title: 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
ispublished: pub
subjects: GOSH
subjects: RFH
divisions: UCL
divisions: B02
divisions: C10
divisions: D17
divisions: K71
divisions: D01
keywords: Latent tuberculosis treatment, Randomised controlled trial, Rifapentine, Tuberculosis
note: This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
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 ).
date: 2021-01-21
date_type: published
official_url: https://doi.org/10.1186/s12879-021-05766-9
oa_status: green
full_text_type: pub
pmcid: PMC7818935
language: eng
primo: open
primo_central: open_green
verified: verified_manual
elements_id: 1844160
doi: 10.1186/s12879-021-05766-9
pii: 10.1186/s12879-021-05766-9
lyricists_name: Abubakar, Ibrahim
lyricists_name: Gosce, Lara
lyricists_name: Lipman, Marc
lyricists_name: Rangaka, Molebogeng
lyricists_name: Stagg, Helen Ruth
lyricists_name: Surey, Julian
lyricists_id: IABUB15
lyricists_id: LGOCS17
lyricists_id: MCILI78
lyricists_id: LRANG97
lyricists_id: HSTAG92
lyricists_id: JJSUR21
actors_name: Flynn, Bernadette
actors_id: BFFLY94
actors_role: owner
full_text_status: public
publication: BMC Infectious Diseases
volume: 21
article_number: 90
event_location: England
citation:        Surey, J;    Stagg, HR;    Yates, TA;    Lipman, M;    White, PJ;    Charlett, A;    Muñoz, L;                         ... Abubakar, I; + view all <#>        Surey, J;  Stagg, HR;  Yates, TA;  Lipman, M;  White, PJ;  Charlett, A;  Muñoz, L;  Gosce, L;  Rangaka, MX;  Francis, M;  Hack, V;  Kunst, H;  Abubakar, I;   - view fewer <#>    (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     , Article 90.  10.1186/s12879-021-05766-9 <https://doi.org/10.1186/s12879-021-05766-9>.       Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/10120483/1/s12879-021-05766-9.pdf