Hello. I'm Dr. Sundari Mase, a medical officer in the Division of Tuberculosis Elimination at the Centers for Disease Control and Prevention (CDC). I'm happy to speak with you as part of CDC's Expert Video Commentary series on Medscape. Today, I will talk about multidrug-resistant tuberculosis (MDR TB) and the recently released CDC guidelines for the use and monitoring of a new TB drug called bedaquiline.
In the past several decades, we have witnessed the emergence of increasingly drug-resistant strains of TB bacteria. MDR TB is caused by organisms that are resistant to at least 2 of the best anti-TB drugs: isoniazid and rifampin. In the United States, MDR TB accounted for 83 cases (1.1%) of all TB cases with drug-susceptibility testing completed in 2012.[1]
MDR TB is more difficult and costly to treat than drug-susceptible TB, and patient outcomes are worse. Whereas drug-susceptible TB takes 6-12 months to cure and costs an average of $17,000 to treat, MDR TB can take up to 24 months to cure and costs an average of $134,000 to treat, with some cases costing much more. Curing patients with drug-resistant TB and interrupting the spread of these strains of TB bacteria requires a wide range of resources, including effective antibiotics.
Bedaquiline is the first drug in a new class of anti-TB medications to be approved in more than 40 years by the US Food and Drug Administration (FDA). It is important to note, however, that owing to the potential for severe adverse events, bedaquiline is not recommended for all patients with MDR TB. Bedaquiline may be used for 24 weeks of treatment in adults with laboratory-confirmed pulmonary MDR TB when an effective treatment regimen cannot otherwise be provided.
In October 2013, CDC issued provisional guidelines[2] to provide additional information for clinicians and public health programs on the best use of bedaquiline to treat patients diagnosed with MDR TB. Patients treated with bedaquiline should be managed by, or in close consultation with, local health departments and experts in the management of drug-resistant TB.
The current recommended dose of bedaquiline is 400 mg given orally with food, by directly observed therapy, once daily for 2 weeks; followed by 200 mg given 3 times per week for an additional 22 weeks. To lessen the chance for TB bacteria to become resistant to bedaquiline, this antibiotic should only be used in combination with at least 3-4 other antibiotics to which laboratory tests indicate that the bacteria is susceptible.
Once a week, patients should be assessed for nausea, headache, hemoptysis, chest pain, joint pain, and rash. An electrocardiogram should be obtained before treatment is begun, and again at 2, 12, and 24 weeks after treatment is started. Patients should also be monitored for liver-related adverse drug reactions with serum transaminases.
Therapeutic drug monitoring should also be considered in patients with severe renal impairment, or if bedaquiline is given with other drugs that induce or suppress the cytochrome P450 system.
Bedaquiline may be used on a case-by-case basis in children, HIV-infected persons, pregnant women, persons with extrapulmonary MDR TB, and patients with comorbid conditions on medications, when an effective treatment regimen cannot otherwise be provided. Patients who take bedaquiline should be monitored closely for suspected and severe adverse events, and all adverse events should be reported to the FDA through MedWatch and to CDC.
Although the approval of bedaquiline for the treatment of MDR TB represents a critical step forward in eliminating TB in the United States, we need to continue to develop treatment options for TB.
For more information about MDR TB, visit the CDC Website.
Dr. Sundari Mase
is the Medical Team Lead in the Field Services and Evaluation Branch, Division of Tuberculosis Elimination, Centers for Disease Control and Prevention. She is a national expert on MDR TB; principal author of the MMWR publication "Provisional CDC Guidelines for the Use and Safety Monitoring of Bedaquiline Fumarate (Sirturo) for the Treatment of Multidrug-Resistant Tuberculosis"; provides medical consultation and technical assistance for complex TB cases and situations; and participates in original research.
Gastrointestinal Tuberculosis Imaging
Tuberculosis (TB)
Miliary Tuberculosis
COMMENTARY
New Drug Available to Treat Multidrug-Resistant Tuberculosis
Sundari Mase, MD, MPH
DisclosuresMarch 31, 2014
Editorial Collaboration
Medscape &
Hello. I'm Dr. Sundari Mase, a medical officer in the Division of Tuberculosis Elimination at the Centers for Disease Control and Prevention (CDC). I'm happy to speak with you as part of CDC's Expert Video Commentary series on Medscape. Today, I will talk about multidrug-resistant tuberculosis (MDR TB) and the recently released CDC guidelines for the use and monitoring of a new TB drug called bedaquiline.
In the past several decades, we have witnessed the emergence of increasingly drug-resistant strains of TB bacteria. MDR TB is caused by organisms that are resistant to at least 2 of the best anti-TB drugs: isoniazid and rifampin. In the United States, MDR TB accounted for 83 cases (1.1%) of all TB cases with drug-susceptibility testing completed in 2012.[1]
MDR TB is more difficult and costly to treat than drug-susceptible TB, and patient outcomes are worse. Whereas drug-susceptible TB takes 6-12 months to cure and costs an average of $17,000 to treat, MDR TB can take up to 24 months to cure and costs an average of $134,000 to treat, with some cases costing much more. Curing patients with drug-resistant TB and interrupting the spread of these strains of TB bacteria requires a wide range of resources, including effective antibiotics.
Bedaquiline is the first drug in a new class of anti-TB medications to be approved in more than 40 years by the US Food and Drug Administration (FDA). It is important to note, however, that owing to the potential for severe adverse events, bedaquiline is not recommended for all patients with MDR TB. Bedaquiline may be used for 24 weeks of treatment in adults with laboratory-confirmed pulmonary MDR TB when an effective treatment regimen cannot otherwise be provided.
In October 2013, CDC issued provisional guidelines[2] to provide additional information for clinicians and public health programs on the best use of bedaquiline to treat patients diagnosed with MDR TB. Patients treated with bedaquiline should be managed by, or in close consultation with, local health departments and experts in the management of drug-resistant TB.
The current recommended dose of bedaquiline is 400 mg given orally with food, by directly observed therapy, once daily for 2 weeks; followed by 200 mg given 3 times per week for an additional 22 weeks. To lessen the chance for TB bacteria to become resistant to bedaquiline, this antibiotic should only be used in combination with at least 3-4 other antibiotics to which laboratory tests indicate that the bacteria is susceptible.
Once a week, patients should be assessed for nausea, headache, hemoptysis, chest pain, joint pain, and rash. An electrocardiogram should be obtained before treatment is begun, and again at 2, 12, and 24 weeks after treatment is started. Patients should also be monitored for liver-related adverse drug reactions with serum transaminases.
Therapeutic drug monitoring should also be considered in patients with severe renal impairment, or if bedaquiline is given with other drugs that induce or suppress the cytochrome P450 system.
Bedaquiline may be used on a case-by-case basis in children, HIV-infected persons, pregnant women, persons with extrapulmonary MDR TB, and patients with comorbid conditions on medications, when an effective treatment regimen cannot otherwise be provided. Patients who take bedaquiline should be monitored closely for suspected and severe adverse events, and all adverse events should be reported to the FDA through MedWatch and to CDC.
Although the approval of bedaquiline for the treatment of MDR TB represents a critical step forward in eliminating TB in the United States, we need to continue to develop treatment options for TB.
For more information about MDR TB, visit the CDC Website.
Dr. Sundari Mase is the Medical Team Lead in the Field Services and Evaluation Branch, Division of Tuberculosis Elimination, Centers for Disease Control and Prevention. She is a national expert on MDR TB; principal author of the MMWR publication "Provisional CDC Guidelines for the Use and Safety Monitoring of Bedaquiline Fumarate (Sirturo) for the Treatment of Multidrug-Resistant Tuberculosis"; provides medical consultation and technical assistance for complex TB cases and situations; and participates in original research.
Public Information from the CDC and Medscape
Cite this: New Drug Available to Treat Multidrug-Resistant Tuberculosis - Medscape - Mar 31, 2014.
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Authors and Disclosures
Authors and Disclosures
Author
Sundari Mase, MD, MPH
Division of Tuberculosis Elimination, National Center for HIV, Hepatitis, STDs, and Tuberculosis Prevention, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
Disclosure: Sundari Mase, MD, MPH, has disclosed no relevant financial relationships.