Treatment of drug-resistant tuberculosis with bedaquiline in a high HIV prevalence setting: an interim cohort analysis
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58 (64%) had completed 24 weeks of BDQ, 28 were still on BDQ, 3 were lost to follow-up, 1 had died and 1 had BDQ withdrawn following atrial fibrillation.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.
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: 01 August 2015
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