Bedaquiline for the Treatment of Multidrug-resistant Tuberculosis in the United States
Autor: | Samuel Parks, Neha Shah, Barbara Seaworth, Felicia Dworkin, Terence Chorba, Jon Warkentin, Sundari Mase, Ann Belanger, Pennan M. Barry |
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Rok vydání: | 2019 |
Předmět: |
0301 basic medicine
Microbiology (medical) medicine.medical_specialty Tuberculosis 030106 microbiology Antitubercular Agents Article Sputum culture 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine Tuberculosis Multidrug-Resistant medicine Culture conversion Humans 030212 general & internal medicine Diarylquinolines Adverse effect Retrospective Studies medicine.diagnostic_test business.industry Common Terminology Criteria for Adverse Events medicine.disease United States Discontinuation Infectious Diseases Treatment Outcome chemistry Tolerability Bedaquiline business |
Zdroj: | Clin Infect Dis |
ISSN: | 1537-6591 |
Popis: | 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. |
Databáze: | OpenAIRE |
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