Amikacin liposome inhalation suspension (ALIS) treatment resulted in conversion of one-half of patients who primarily had macrolide-resistant Mycobacterium abscessus lung disease, a study shows, but several patients developed mutational amikacin resistance.
Using an open-label protocol, patients received ALIS 590 mg in addition to background multidrug therapy for 12 months. Based on a primary outcome of sputum culture conversion (3 consecutive monthly sputum cultures showing negative results), the study found: “Of 33 patients (36 isolates) who started ALIS with a mean age of 64 years (range, 14-81 years), 24 patients (73%) were female, 10 patients (30%) had cystic fibrosis, and nine patients (27%) had cavitary disease. Three patients (9%) could not be evaluated for the microbiologic end point because of early withdrawal. All pretreatment isolates were amikacin susceptible and only six isolates (17%) were macrolide susceptible. Eleven patients (33%) were given parenteral antibiotics. Twelve patients (40%) received clofazimine with or without azithromycin as companion therapy. Fifteen patients (50%) with evaluable longitudinal microbiologic data demonstrated culture conversion, and 10 patients (67%) sustained conversion through month 12. Six of the 33 patients (18%) demonstrated mutational amikacin resistance. All were patients using clofazimine or clofazimine plus azithromycin as companion medication(s). Few serious adverse events occurred for ALIS users; however, reduction of dosing to three times weekly was common (52%).”