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

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


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58 (64%) had completed 24 weeks of BDQ, 28 were still on BDQ, 3 were lost to follow-up, 1 had died and 1 had BDQ withdrawn following atrial fibrillation.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

MeSH terms

  • Adult
  • Anti-HIV Agents / therapeutic use
  • Antitubercular Agents / adverse effects
  • Antitubercular Agents / therapeutic use*
  • Cohort Studies
  • Diarylquinolines / adverse effects
  • Diarylquinolines / therapeutic use*
  • Extensively Drug-Resistant Tuberculosis / drug therapy*
  • Extensively Drug-Resistant Tuberculosis / epidemiology
  • Extensively Drug-Resistant Tuberculosis / microbiology
  • Female
  • Fluoroquinolones / pharmacology
  • Follow-Up Studies
  • HIV Infections / drug therapy
  • HIV Infections / epidemiology*
  • Humans
  • Male
  • Middle Aged
  • Prevalence
  • Prospective Studies
  • South Africa / epidemiology
  • Treatment Outcome


  • Anti-HIV Agents
  • Antitubercular Agents
  • Diarylquinolines
  • Fluoroquinolones
  • bedaquiline