Bedaquiline for the Treatment of Multidrug-resistant Tuberculosis in the United States

Details

• Journal Article:
  Clin Infect Dis
• Personal Author:
  Mase, Sundari ; Chorba, Terence ; Parks, Samuel ; Belanger, Ann ; Dworkin, Felicia ; Seaworth, Barbara ; Warkentin, Jon ; Barry, Pennan ; Shah, Neha
• Description:
  Background ; In 2012, the Food and Drug Administration approved use of bedaquiline fumarate as part of combination therapy for multidrug-resistant tuberculosis (MDR TB). We describe treatment outcomes, safety, and tolerability of bedaquiline in our case series. ; Methods ; Data on patients started on bedaquiline for MDR TB between September 2012 and August 2016 were collected retrospectively through 4 TB programs using a standardized abstraction tool. Data were analyzed using univariate methods. Adverse events were graded using the Common Terminology Criteria for Adverse Events. ; Results ; Of 14 patients, 7 (50%) had MDR, 4 (29%) had pre-extensively drug-resistant (XDR), and 3 (21%) had XDR TB. All had pulmonary TB, 5 (36%) had pulmonary and extrapulmonary TB, and 9/13 (69%) were smear positive. One patient (7%) had HIV coinfection, 5 (36%) had diabetes mellitus, and 5/14 (36%) had previous treatment TB. All patients were non-US-born and 5/14 (36%) had private insurance. All patients achieved sputum culture conversion within a mean of 71 days (26–116); 5 after starting bedaquiline. Twelve (86%) completed treatment and 1 (7%) moved out of the country. One patient (7%) had QTc prolongation >500 milliseconds and died 20 months after discontinuing bedaquiline of a cause not attributable to the drug. Common adverse events were peripheral neuropathy 7/14 (50%), not customarily associated with bedaquiline use, and QTc prolongation 6/14 (43%). ; Conclusions ; Of 14 patients, 1 (7%) had an adverse event necessitating bedaquiline discontinuation. Safety, culture conversion, and treatment completion in this series (7%) support use of bedaquiline for the treatment of MDR/XDR TB.
• Subjects:
  • Antitubercular Agents
  • Diarylquinolines
  • Humans
  • Retrospective Studies
  • Treatment Outcome
  • Tuberculosis, Multidrug-Resistant
  • United States
• Keywords:
  • multidrug-resistant tuberculosis
  • bedaquiline
  • treatment
  • adverse event
  • outcome
• Source:
  Clin Infect Dis. 71(4):1010-1016
• DOI:
  http://dx.doi.org/10.1093/cid/ciz914
• Pubmed ID:
  31556947
• Pubmed Central ID:
  PMC7350275
• Document Type:
  Text ; Journal Article
• Funding:
  001/WHO_/World Health OrganizationInternational/ ; CC999999/ImCDC/Intramural CDC HHSUnited States/
• Genre:
  Journal Article
• Volume:
  71
• Issue:
  4
• Download URL:
  https://stacks.cdc.gov/view/cdc/90424/cdc_90424_DS1.pdf
• File Type:
  [PDF - 104.52 KB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:722c4f5fa36ab7ddd8457b16a5893cb9c96345efa1866729fe769be3650d627219fd2191704b2311839f899ef94e3f5a50d12b37dce86662880b0cb5fe9517ae