High treatment success rate for multidrug-resistant and extensively drug-resistant tuberculosis using a bedaquiline-containing treatment regimen
- Norbert Ndjeka,
- Kathryn Schnippel,
- Iqbal Master,
- Graeme Meintjes,,
- Gary Maartens,
- Rodolfo Romero,
- Xavier Padanilam,
- Martin Enwerem,
- Sunitha Chotoo,
- Nalini Singh,
- Jennifer Hughes,
- Ebrahim Variava,,
- Hannetjie Ferreira,
- Julian te Riele,
- Nazir Ismail,,,
- Erika Mohr,
- Nonkqubela Bantubani and
- Francesca Conradie
- National TB Programme, National Department of Health, South Africa
- Health Economics Unit, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa
- King Dinuzulu Hospital Complex, Kwazulu Natal Department of Health, Durban, South Africa
- Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa
- Department of Medicine, University of Cape Town, Cape Town, South Africa
- Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa
- Northern Cape Department of Health, Namakwa, South Africa
- Sizwe Tropical Diseases Hospital, Gauteng Department of Health, Johannesburg, South Africa
- Amity Health Consortium, Johannesburg, South Africa
- Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa
- Klerksdorp Tshepong Hospital, North West Department of Health, Klerksdorp, South Africa
- Perinatal HIV Research unit and University of Witswatersrand, Johannesburg, South Africa
- Brooklyn Chest Hospital, Western Cape Department of Health, Cape Town, South Africa
- Centre for Tuberculosis, National Institute for Communicable Diseases, National Health Laboratory Services, Johannesburg, South Africa
- Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa
- Department of Internal Medicine, University of Witwatersrand, Johannesburg, South Africa
- Médecins sans Frontières, Khayelitsha, Cape Town, South Africa
- Medical Research Council, Durban, South Africa
- University of the Witwatersrand, Faculty of Health Sciences, Johannesburg, South Africa
- Norbert Ndjeka, National TB Programme, National Department of Health, South Africa. E-mail: norbert.ndjeka{at}health.gov.za
Abstract
Background: South African patients with rifampicin-resistant tuberculosis and resistance to fluoroquinolones and/or injectables (pre/XDR-TB) were granted access to bedaquiline through a Clinical Access Programme with strict inclusion and exclusion criteria.
Methods: Pre/XDR-TB and XDR-TB patients were treated with 24 weeks bedaquiline within an optimised, individualised background regimen that could include levofloxacin, linezolid and clofazimine as needed.
Results: 200 patients were enrolled: 87 (43.9%) with XDR-TB, 99 (49.3%) were female, median age 34 years (IQR 27, 42). 134 (67.0%) were living with HIV; median CD4+ 281 (IQR 130; 467) and all on antiretroviral therapy.
16/200 patients (8.0%) did not complete 6 months of bedaquiline of which 8 were lost to follow up, 6 died, 1 stopped for side effects and 1 patient was diagnosed with drug-sensitive TB.
146/200 (73.0%) patients had favourable outcomes: 139/200 were cured (69.5%) and 7 completed treatment (3.5%). 25 died (12.5%), were lost from treatment (10.0%), 9 had treatment failure (4.5%).
22 adverse events were attributed to bedaquiline: including QTcF >500 ms (n=5), QTcF increase >50 ms from baseline (n=11), paroxysmal atrial flutter (n=1).
Conclusion: Bedaquiline added to an optimised background regimen was associated with a high rate of successful treatment outcomes for this MDR-TB and XDR-TB cohort.
Footnotes
This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Conflict of interest: Dr. Schnippel has nothing to disclose.
Conflict of interest: Dr. Master has nothing to disclose.
Conflict of interest: Dr. Meintjes has nothing to disclose.
Conflict of interest: Dr. Maartens has nothing to disclose.
Conflict of interest: Dr. PADANILAM has nothing to disclose.
Conflict of interest: Dr. Enwerem has nothing to disclose.
Conflict of interest: Dr. Chotoo has nothing to disclose.
Conflict of interest: Dr. Singh has nothing to disclose.
Conflict of interest: Dr. Hughes has nothing to disclose.
Conflict of interest: Dr. Variava has nothing to disclose.
Conflict of interest: Dr. Ferreira has nothing to disclose.
Conflict of interest: Dr. te Riele has nothing to disclose.
Conflict of interest: Mrs. Mohr has nothing to disclose.
Conflict of interest: Dr. Bantubani has nothing to disclose.
Conflict of interest: Dr. Ismail has nothing to disclose.
Conflict of interest: Dr. Conradie reports other from Janssen Pharmacuetica, outside the submitted work.
Conflict of interest: Dr. Romero Leyet has nothing to disclose.
Conflict of interest: Dr. Ndjeka reports non-financial support from Janssen Pharmaceutica, during the conduct of the study; and Janssen Pharmaceutica has provided support to the SA TB Programme: funding for training, provision of ECG machines and hearing tests machines.
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