| Title: |
Amikacin liposome inhalation suspension for treatment-refractory lung disease caused by Mycobacterium avium complex (CONVERT). A prospective, open-label, randomized study |
| Authors: |
Griffith, David E.; Eagle, Gina; Thomson, Rachel; Aksamit, Timothy R.; Hasegawa, Naoki; Morimoto, Kozo; Addrizzo-Harris, Doreen J.; O'Donnell, Anne E.; Marras, Theodore K.; Flume, Patrick A.; Loebinger, Michael R.; Morgan, Lucy; Codecasa, Luigi R.; Hill, Adam T.; Ruoss, Stephen J.; Yim, Jae-Joon; Ringshausen, Felix C.; Field, Stephen K.; Philley, Julie V.; Wallace, Richard J., Jr.; van Ingen, Jakko; Coulter, Chris; Nezamis, James; Winthrop, Kevin L.; CONVERT Study Grp |
| Contributors: |
Yim, Jae-Joon |
| Publisher Information: |
American Thoracic Society |
| Publication Year: |
2019 |
| Collection: |
Seoul National University: S-Space |
| Subject Terms: |
NONTUBERCULOUS MYCOBACTERIA; PULMONARY-DISEASE; INHALED AMIKACIN; PREVALENCE; THERAPY; DEPOSITION; MORTALITY; ONTARIO; CANADA; guideline-based therapy; culture conversion; liposomal amikacin for inhalation; ALIS |
| Description: |
Rationale: Improved therapeutic options are needed for patients with treatment-refractory nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC). Objectives: To evaluate the efficacy and safety of daily amikacin liposome inhalation suspension (ALIS) added to standard guideline-based therapy (GBT) in patients with refractory MAC lung disease. Methods: Adults with amikacin-susceptible MAC lung disease and MAC-positive sputum cultures despite at least 6 months of stable GBT were randomly assigned (2: 1) to receive ALIS with GBT (ALIS + GBT) or GBT alone. Once-daily ALIS was supplied in single-use vials delivering 590 mg amikacin to the nebulizer. The primary endpoint was culture conversion, defined as three consecutive monthly MAC-negative sputum cultures by Month 6. Measurements and Main Results: Enrolled patients (ALIS + GBT, n = 224; GBT-alone, n = 112) were a mean 64.7 years old and 69.3% female. Most had underlying bronchiectasis (62.5%), chronic obstructive pulmonary disease (14.3%), or both (11.9%). Culture conversion was achieved by 65 of 224 patients (29.0%) with ALIS + GBT and 10 of 112 (8.9%) with GBT alone (odds ratio, 4.22; 95% confidence interval, 2.08-8.57; P < 0.001). Patients in the ALIS + GBT arm versus GBT alone were more likely to achieve conversion (hazard ratio, 3.90; 95% confidence interval, 2.00-7.60). Respiratory adverse events (primarily dysphonia, cough, and dyspnea) were reported in 87.4% of patients receiving ALIS + GBT and 50.0% receiving GBT alone; serious treatment-emergent adverse events occurred in 20.2% and 17.9% of patients, respectively. Conclusions: Addition of ALIS to GBT for treatment-refractory MAC lung disease achieved significantly greater culture conversion by Month 6 than GBT alone, with comparable rates of serious adverse events. ; N ; 1 |
| Document Type: |
article in journal/newspaper |
| Language: |
unknown |
| Relation: |
https://hdl.handle.net/10371/206356; 000453253600018; 81568 |
| DOI: |
10.1164/rccm.201807-1318OC |
| Availability: |
https://hdl.handle.net/10371/206356; https://doi.org/10.1164/rccm.201807-1318OC |
| Accession Number: |
edsbas.7C244AAE |
| Database: |
BASE |