SESSION TITLE: Infectious Diseases Cases I
SESSION TYPE: Affiliate Case Report Slide
PRESENTED ON: Tuesday, October 27, 2015 at 07:30 AM - 08:30 AM
INTRODUCTION: Achieving negative NTM cultures is useful in assessing treatment effectiveness, and is a clinically important endpoint in NTM lung infection.(1,2) LAI is a novel amikacin formulation evaluated in TR02-112, a placebo (PBO)-controlled study in adults with NTM lung infection refractory to guideline-based therapy for ≥6 months. Here we present data on a patient with Mycobacterium avium complex (MAC) NTM infection who was enrolled in TR02-112, randomized to PBO in the 84-day double-blind (DB) phase, and transitioned to LAI 590 mg QD in the open-label (OL) phase for 84 more days.
CASE PRESENTATION: A 53-year old female with a history of asthma, treated with an inhaled corticosteroid and an anti-IgE monoclonal antibody, was diagnosed with MAC infection in April 2010. In June 2010, due to progressive fatigue and dyspnea on exertion, she began a suboptimal multidrug regimen of daily oral clarithromycin (cla) 500 mg, ethambutol (eth) 800 mg, and rifampin (rif) 600 mg at an outside institution. Her sputum remained culture-positive when she presented to NYU 18 months later and had her regimen optimized to cla 500 mg twice daily, eth 900 mg QD, and rif 600 mg QD. Despite 9 months of optimal therapy, her sputum remained culture-positive until September 2012, when she started PBO in TR02-112. She remained culture-positive through the DB phase. Upon transitioning to LAI in the OL phase, her sputum cultures converted to negative after 1 month and remained negative through the OL phase and the 28-day follow-up. She tolerated LAI well, mainly complaining of hoarseness, which improved with reduction in LAI frequency from 7 to 5 days/week.
DISCUSSION: Patients with refractory NTM lung infection have limited therapeutic options and are often treated for lengthy durations with multidrug regimens.(1,2) Adding LAI to this patient’s regimen converted her sputum cultures to negative after 1 month, which has implications for shortening overall treatment durations.
CONCLUSIONS: LAI was effective in achieving and maintaining negative cultures in a patient with treatment-refractory NTM lung infection. Further LAI studies are warranted.
Reference #1: Griffith DE, Aksamit T, Borwn-Elliott BA, et al. Am J Respir Crit Care Med. 2007;175(4):367-416.
Reference #2: Griffith DE, Aksamit TR. Curr Opin Infect Dis. 2012;25(2):218-227.
DISCLOSURE: Stephanie Lau: Other: Study Coordinator for Insmed TRO2-112 trial Gina Eagle: Employee: Insmed employee John McGinnis: Employee: Insmed employee Liza Micioni: Employee: Insmed employee Doreen Addrizzo-Harris: Grant monies (from industry related sources): Principal Investigator for Insmed TR02-112 Trial, Grant monies (from industry related sources): Principal Investigator for Aradigm ORBIT-4 trial The following authors have nothing to disclose: Dena Daglian
Liposomal amikacin for inhalation (LAI) is a novel formulation of amikaicn which is not FDA approved. LAI is comprised of amikacin sulfate encapsulated in liposomes. LAI is being studied in clinical trials in the treatment of non-tuberculous mycobaterial lung infection.