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Int J Tuberc Lung Dis. 2015 Aug;19(8):979-85. doi: 10.5588/ijtld.14.0944.

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

Author information

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

Abstract

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58 (64%) had completed 24 weeks of BDQ, 28 were still on BDQ, 3 were lost to follow-up, 1 had died and 1 had BDQ withdrawn following atrial fibrillation.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.

PMID:
26162365
DOI:
10.5588/ijtld.14.0944
[Indexed for MEDLINE]

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