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Compassionate Use of Bedaquiline in the Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis FREE TO VIEW

Melissa Lesko, DO; Mauricio Danckers Degregori, MD; Rosemary Adamson, MD; Eric Leibert, MD
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New York University School of Medicine, New York, NY

Chest. 2014;146(4_MeetingAbstracts):132A. doi:10.1378/chest.1989104
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SESSION TITLE: Infectious Disease Case Report Posters

SESSION TYPE: Affiliate Case Report Poster

PRESENTED ON: Tuesday, October 28, 2014 at 01:30 PM - 02:30 PM

INTRODUCTION: Extensively Drug Resistant Tuberculosis (XDR-TB), is uncommon in developed countries with only 63 cases reported in the US between 1993-2011. Treatment is tailored to culture sensitivities with second line anti-tuberculosis (anti-TB) drugs. We report the first case in United States of compassionate use of bedaquiline for the treatment of pulmonary XDR-TB.

CASE PRESENTATION: A 30 year-old man, former smoker, with diabetes, presented with fevers and hemoptysis one month after immigrating to New York from a high incidence country. His chest x-ray revealed bilateral cavitary upper lobe infiltrates (Figure 1). Sputum smears for acid-fast bacilli were positive as were cultures for Mycobacterium Tuberculosis. He was empirically started on first-line anti-TB drugs, and his regimen was modified as results from susceptibility testing became available eventually revealing XDR-TB. He was ultimately treated with pyrazinamide, ethionamide, paraminosalycilic acid, cycloserine, capreomycin, amoxicillin/clavulanic, meropenem and linezolid. As a result of multiple adverse effects from his XDR-TB treatment, especially linezolid induced demyelinating peripheral neuropathy, bedaquiline was obtained through a compassionate use program in order to maintain an effective treatment regimen for XDR-TB after the discontinuation of linezolid. He tolerated bedaquiline well experiencing only mild transaminitis and successfully completed his XDR-TB treatment.

DISCUSSION: Three cases in the literature pertain to the compassionate use of bedaquiline. In each of these cases, bedaquiline was added in place of a fourth agent in a treatment regimen when there were no additional options remaining. QTC prolongation and increased risk of death have been noted in patients receiving bedaquiline. High incidences of nausea (35.3% vs. 25.7%) and hepatotoxicity (8.8% vs. 1.9%) have also been reported with bedaquiline when compared to placebo.

CONCLUSIONS: Bedaquiline is a novel agent for the treatment of Pre-XDR or XDR Tuberculosis. In our patient bedaquiline was added to an effective XDR regimen to ameliorate the side effect profile in order to allow for the successful completion of therapy.

Reference #1: CDC, Trends in Tuberculosis - United States, 2011. MMWR, 2012. 61(11): p. 181-185.

Reference #2: Tiberi, S., et al., Bedaquiline in MDR/XDR-TB cases: first experience on compassionate use. Eur Respir J, 2014. 43(1): p. 289-92.

Reference #3: Diacon, A.H., et al., The diarylquinoline TMC207 for multidrug-resistant tuberculosis. N Engl J Med, 2009. 360(23): p. 2397-405.

DISCLOSURE: The following authors have nothing to disclose: Melissa Lesko, Mauricio Danckers Degregori, Rosemary Adamson, Eric Leibert

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