2260. Clofazimine Safety and Efficacy for Treatment of Multidrug-Resistant Non-Tuberculous Mycobacteria (NTM)

Abstract

BackgroundNontuberculous mycobacteria (NTM) are increasingly detected and challenging to cure given complex drug-resistance patterns and need to use often intolerable drug multidrug regimens over months to years of duration. As such, NTM infection can be associated with significant mortality and morbidity. Clofazimine is a repurposed drug used in the treatment of leprosy worldwide and increasingly in multidrug-resistant (MDR) tuberculosis. Some centers in the United States have incorporated clofazimine in the treatment of NTM but experience is limited and procurement restrictions have hampered its more widespread useMethodsA prospective cohort study was performed in patients diagnosed with pulmonary or extrapulmonary NTM infection among those treated with clofazimine from a single center serving referrals from across the state of Virginia under an investigational new drug protocol. Data were collected through the center’s electronic medical record and included both pretreatment and follow-up host characteristics, radiological, microbiological and pathology data. Outcomes were assessed, radiological resolution, symptom improvement, and change in pulmonary function test (among patients with cystic fibrosis).ResultsThirty-seven patients received clofazimine. NTM species for which the treatment was indicated were M. abscessus in 21 (58%), M. avium complex in 17 (45%) and 3 with M. chelonae. The most common companion drugs for M. abscessus included imipenem, tigecycline, linezolid or tedizolid, amikacin (IV induction followed by inhaled continuation phase) and azithromycin. For other basic patient characteristics refer to Table 1. Survival rate was 97%, while 73.5% had documented improvement in symptoms and only 2.9% had worsening of symptoms. Radiological resolution or partially improving were documented in 38% of the patients. there were no severe adverse events from clofazimine.ConclusionAdding clofazimine to multi-class antibiotic regimens for drug-resistant NTM treatment, including pulmonary M. abscessus disease, was well tolerated and led to clinical improvement in the majority of those treated. Randomized controlled studies are needed to determine the individual impact of clofazimine within and otherwise optimized regimen. Disclosures All authors: No reported disclosures.