![]() On August 14, 2019, the Food and Drug Administration (FDA) approved the use of pretomanid as part of an all-oral combination (with bedaquiline and linezolid, together ) administered by direct observation to adults with a diagnosis of pulmonary extensively drug-resistant or treatment-intolerant or nonresponsive (TI/ NR) MDR TB, based on limited clinical safety and efficacy data. Pretomanid tablets label and full prescribing information. BPaL was approved in accordance with the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) for development of drugs targeting infections that lack effective therapies. On August 14, 2019, the Food and Drug Administration (FDA) approved use of pretomanid with bedaquiline and linezolid (BPaL) as a treatment regimen for pulmonary MDR TB additionally resistant to at least one fluoroquinolone or injectable medication and for pulmonary MDR TB that is treatment-intolerant/nonresponsive (TI/NR MDR TB). Pretomanid (formerly PA-824) is an oral bicyclic nitroimidazooxazine. Of 518 MDR TB patients alive at diagnosis, 63% were reported as completing treatment within 24 months, and 8% died before treatment completion (CDC, unpublished data, 2021). During 2014–2018, 524 new cases of MDR TB were reported in the United States and U.S.-affiliated areas (territories and freely associated states), including 443 with resistance to isoniazid and rifampin alone, 72 with additional resistance to a fluoroquinolone or an injectable (assessed as amikacin, kanamycin, capreomycin), and 9 with additional resistance to both a fluoroquinolone and an injectable (CDC, unpublished data, 2021). Įven as efficacy of drug regimens has improved, side effects and length of treatment have continued to be challenges in treating patients with drug-resistant TB. Rifamycin-monoresistant (RMR) TB, in the absence of INH resistance, although rare, has also been challenging to treat and associated with poor outcomes. ![]() Multidrug-resistant tuberculosis (MDR TB), caused by MTB that is resistant to at least isoniazid (INH) and rifampin (RIF), has traditionally required longer, more intensive treatment than drug-susceptible disease, including 15–21 months of treatment after culture conversion with 4–7 drugs that are less effective, more toxic, and more costly in treating MDR TB than is a standard first-line regimen in treating drug-susceptible TB. TB infection is usually transmitted from one person to another by airborne droplet nuclei containing the bacteria. Tuberculosis (TB) is caused by bacteria of the Mycobacterium tuberculosis complex, most commonly M. CDC guidance is based on clinical trials with small numbers of enrollees rare adverse events may be detected as more patients use the BPaL regimen.is actively being studied in combination with other anti-TB medications not included in the BPaL regimen. ![]() is not indicated for use alone and has not been FDA-approved for use in combination with other anti-TB medications not included in the BPaL regimen, and.is approved for treatment of pulmonary TB, and not yet approved for treatment of extrapulmonary TB,.can be extended to 9 months (39 weeks) within the BPaL regimen based on delayed treatment response within the first 8 weeks,.CDC recommends an initial linezolid dose of 600 mg when using the BPaL regimen in the treatment of adults. ![]() CDC recommends the use of pretomanid 200mg daily for 26 weeks in the treatment of adults with pulmonary MDR TB (resistant to isoniazid and rifampin) additionally resistant to at least one fluoroquinolone or injectable medication (i.e., amikacin, kanamycin, capreomycin) or with treatment-intolerant/nonresponsive MDR TB, when administered in combination with bedaquiline and linezolid as the BPaL regimen. A physician with expertise in drug-resistant TB treatment should be involved in the patient’s treatment plan.In August 2019, FDA approved the use of pretomanid 200mg in combination with bedaquiline and linezolid (BPaL) in adults with pulmonary extensively drug resistant (XDR), treatment-intolerant, or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). ![]()
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