Amikacin Liposome Inhalation Suspension for Refractory Mycobacterium avium Complex Lung Disease
| Autor: | Timothy R. Aksamit, Richard J. Wallace, Dayton W. Yuen, Kozo Morimoto, Wouter Hoefsloot, David E. Griffith, Doreen Addrizzo-Harris, Kevin L. Winthrop, Kevin C. Mange, Monika Ciesielska, Rachel Thomson, Jakko van Ingen, Chris Coulter, Stephen K. Field, Patrick A. Flume, Barbara A. Brown-Elliott |
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| Rok vydání: | 2021 |
| Předmět: |
Pulmonary and Respiratory Medicine
education.field_of_study medicine.medical_specialty medicine.diagnostic_test Inhalation business.industry Population Critical Care and Intensive Care Medicine Gastroenterology respiratory tract diseases Sputum culture 03 medical and health sciences 0302 clinical medicine 030228 respiratory system Refractory Interquartile range Internal medicine Clinical endpoint Culture conversion Medicine 030212 general & internal medicine Cardiology and Cardiovascular Medicine business education Adverse effect |
| Zdroj: | Chest. 160:831-842 |
| ISSN: | 0012-3692 |
| DOI: | 10.1016/j.chest.2021.03.070 |
| Popis: | Background: In the CONVERT study, treatment with amikacin liposome inhalation suspension (ALIS) added to guideline-based therapy (GBT) met the primary end point of increased culture conversion by month 6 in patients with treatment-refractory Mycobacterium avium complex lung disease (ALIS plus GBT, 29% [65/224] vs GBT alone, 8.9% [10/112]; P < .0001). Research Question: In patients who achieved culture conversion by month 6 in the CONVERT study, was conversion sustained (negative sputum culture results for 12 months with treatment) and durable (negative sputum culture results for 3 months after treatment) and were there any additional safety signals associated with a full treatment course of 12 months after conversion? Study Design and Methods: Adults were randomized 2:1 to receive ALIS plus GBT or GBT alone. Patients achieving culture conversion by month 6 continued therapy for 12 months followed by off-treatment observation. Results: More patients randomized to ALIS plus GBT (intention-to-treat population) achieved conversion that was both sustained and durable 3 months after treatment vs patients randomized to GBT alone (ALIS plus GBT, 16.1% [36/224] vs GBT alone, 0% [0/112]; P < .0001). Of the patients who achieved culture conversion by month 6, 55.4% of converters (36/65) in the ALIS plus GBT treated arm vs no converters (0/10) in the GBT alone arm achieved sustained and durable conversion (P = .0017). Relapse rates through 3 months after treatment were 9.2% (6/65) in the ALIS plus GBT arm and 30.0% (3/10) in the GBT alone arm. Common adverse events among ALIS plus GBT-treated patients (dysphonia, cough, dyspnea, hemoptysis) occurred mainly within the first 8 months of treatment. Interpretation: In a refractory population, conversion was sustained and durable in more patients treated with ALIS plus GBT for 12 months after conversion than in those treated with GBT alone. No new safety signals were associated with 12 months of treatment after conversion. Trial Registry: ClinicalTrials.gov; No.: NCT02344004; URL: www.clinicaltrials.gov |
| Databáze: | OpenAIRE |
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