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Free Content Treatment of drug-resistant tuberculosis with bedaquiline in a high HIV prevalence setting: an interim cohort analysis

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BACKGROUND: South Africa has a large burden of extensively drug-resistant tuberculosis (XDR-TB); only 15% of XDR-TB patients have successful outcomes.

OBJECTIVE: To describe the safety and effectiveness of bedaquiline (BDQ) in the South African BDQ Clinical Access Programme.

DESIGN: An interim cohort analysis.

RESULTS: Of the first 91 patients enrolled between March 2013 and July 2014 (with follow-up until August 2014), 54 (59%) were human immunodeficiency virus (HIV) infected. The median CD4 count was 239 cells/μl, and all patients were on antiretroviral therapy (ART) at initiation of BDQ; 33 had XDR-TB, 41 were pre-XDR-TB with fluoroquinolone resistance and 17 were pre-XDR-TB with resistance to an injectable. Of the 91 patients, 58 (64%) had completed 24 weeks of BDQ, 28 were still on BDQ, 3 were lost to follow-up, 1 had died and 1 had BDQ withdrawn following atrial fibrillation. Of the 63 patients with 6 months follow-up, 48 (76%) had either culture-converted or remained culture-negative after initiation of BDQ. QTcF was monitored monthly and exceeded 500 ms in three participants; this resolved in all three.

CONCLUSION: Interim safety and culture conversion outcomes for patients accessing BDQ in South Africa, including HIV-infected patients on ART and patients with pre-XDR- and XDR-TB, suggest that BDQ may be both efficacious and safe.
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Keywords: South Africa; adverse events; compassionate access; extensively drug-resistant tuberculosis

Document Type: Research Article

Affiliations: 1: *National Department of Health, Pretoria, 2: Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, Right to Care, Johannesburg 3: §Médecins sans Frontières, Khayelitsha, Cape Town 4: TB/HIV Investigative Network of Kwazulu-Natal, Durban 5: #Klerksdorp Tshepong Hospital Complex, Klerksdorp 6: **Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, ††Department of Medicine, University of Cape Town, Cape Town 7: ††Sizwe Tropical Disease Hospital, Johannesburg 8: Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, #Klerksdorp Tshepong Hospital Complex, Klerksdorp 9: Kwazulu-Natal Research Institute for TB and HIV, Durban, South Africa

Publication date: August 1, 2015

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on lung health world-wide.

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