Treatment outcomes 24 months after initiating short, all-oral bedaquiline-containing or injectable-containing rifampicin-resistant tuberculosis treatment regimens in South Africa : a retrospective cohort study

dc.contributor.authorNdjeka, Norbert
dc.contributor.authorCampbell, Jonathon R.
dc.contributor.authorMeintjes, Graeme
dc.contributor.authorMaartens, Gary
dc.contributor.authorSchaaf, H. Simon
dc.contributor.authorHughes, Jennifer
dc.contributor.authorPadanilam, Xavier
dc.contributor.authorReuter, Anja
dc.contributor.authorRomero, Rodolfo
dc.contributor.authorIsmail, Farzanah
dc.contributor.authorEnwerem, Martin
dc.contributor.authorFerreira, Hannetjie
dc.contributor.authorConradie, Francesca
dc.contributor.authorNaidoo, Kogieleum
dc.contributor.authorMenzies, Dick
dc.date.accessioned2023-07-20T07:39:27Z
dc.date.available2023-07-20T07:39:27Z
dc.date.issued2022-07
dc.descriptionDATA SHARING : The data used for this analysis in the form of deidentified participant data and a data dictionary will be made available after publication. Investigators wishing to access these data will need to have an approved research proposal and complete a data access agreement. All inquiries should be sent to the corresponding author (Norbert.Ndjeka@health.gov.za or norbertndjeka@gmail.com).en_US
dc.descriptionSUPPLEMENTARY MATERIAL 1 : French translation of the abstract. SUPPLEMENTARY MATERIAL 2 : Appendices.en_US
dc.description.abstractBACKGROUND : There is a need for short and safe all-oral treatment of rifampicin-resistant tuberculosis. We compared outcomes up to 24 months after treatment initiation for patients with rifampicin-resistant tuberculosis in South Africa treated with a short, all-oral bedaquiline-containing regimen (bedaquiline group), or a short, injectable-containing regimen (injectable group). METHODS : Patients with rifampicin-resistant tuberculosis, aged 18 years or older, eligible for a short regimen starting treatment between Jan 1 and Dec 31, 2017, with a bedaquiline-containing or WHO recommended injectable-containing treatment regimen of 9–12 months, registered in the drug-resistant tuberculosis database (EDRWeb), and with known age, sex, HIV status, and national identification number were eligible for study inclusion; patients receiving linezolid, carbapenems, terizidone or cycloserine, delamanid, or para-aminosalicylic acid were excluded. Bedaquiline was given at a dose of 400 mg once daily for two weeks followed by 200 mg three times a week for 22 weeks. To compare regimens, patients were exactly matched on HIV and ART status, previous tuberculosis treatment history, and baseline acid-fast bacilli smear and culture result, while propensity score matched on age, sex, province of treatment, and isoniazid-susceptibility status. We did binomial linear regression to estimate adjusted risk differences (aRD) and 95% CIs for 24-month outcomes, which included: treatment success (ie, cure or treatment completion without evidence of recurrence) versus all other outcomes, survival versus death, disease free survival versus survival with treatment failure or recurrence, and loss to follow-up versus all other outcomes. FINDINGS : Overall, 1387 (14%) of 10152 patients with rifampicin-resistant tuberculosis treated during 2017 met inclusion criteria; 688 in the bedaquiline group and 699 in the injectable group. Four patients (1%) had treatment failure or recurrence, 44 (6%) were lost to follow-up, and 162 (24%) died in the bedaquiline group, compared with 17 (2%), 87 (12%), and 199 (28%), respectively, in the injectable group. In adjusted analyses, treatment success was 14% (95% CI 8–20) higher in the bedaquiline group than in the injectable group (70% vs 57%); loss to follow-up was 4% (1–8) lower in the bedaquiline group (6% vs 12%); and disease-free survival was 2% (0–5) higher in the bedaquiline group (99% vs 97%). The bedaquiline group had 8% (4–11) lower risk of mortality during treatment (17·0% vs 22·4%), but there was no difference in mortality post-treatment. INTERPRETATION : Patients in the bedaquiline group experienced significantly higher rates of treatment success at 24 months. This finding supports the use of short bedaquiline-containing regimens in eligible patients.en_US
dc.description.departmentMedical Microbiologyen_US
dc.description.librarianhj2023en_US
dc.description.sponsorshipWHO Global TB Programme.en_US
dc.description.urihttp://www.thelancet.com/infectionen_US
dc.identifier.citationNdjeka, N., Campbell, J.R., Meintjes, G., et al. 2022, 'Treatment outcomes 24 months after initiating short, all-oral bedaquiline-containing or injectable-containing rifampicin-resistant tuberculosis treatment regimens in South Africa: a retrospective cohort study', Lancet Infectious Diseases, vol. 22, no. 7, pp. 1042-1051, doi : 10.1016/S1473-3099(21)00811-2.en_US
dc.identifier.issn1473-3099 (print)
dc.identifier.issn1474-4457 (online)
dc.identifier.other10.1016/S1473-3099(21)00811-2
dc.identifier.urihttp://hdl.handle.net/2263/91558
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.rights© 2021 World Health Organization; licensee Elsevier. This is an Open Access article published under the CC BY 3.0 IGO license.en_US
dc.subjectRifampicin-resistant tuberculosisen_US
dc.subjectSouth Africa (SA)en_US
dc.subjectAll-oral treatmenten_US
dc.subjectSDG-03: Good health and well-beingen_US
dc.subjectBedaquiline-containing regimenen_US
dc.subjectInjectable-containing regimenen_US
dc.titleTreatment outcomes 24 months after initiating short, all-oral bedaquiline-containing or injectable-containing rifampicin-resistant tuberculosis treatment regimens in South Africa : a retrospective cohort studyen_US
dc.typeArticleen_US

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