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Amikacin Liposome Inhalation Suspension for Mycobacterium avium Complex Lung Disease: A 12-Month Open-Label Extension

Kevin L Winthrop1, Patrick A Flume2, Rachel Thomson3

  • 1Division of Infectious Disease, Oregon Health and Science University Schools of Medicine and Public Health, Portland, Oregon.

Annals of the American Thoracic Society
|December 16, 2020
PubMed

Insights

Amikacin liposome inhalation suspension (ALIS) plus guideline-based therapy (GBT) showed continued culture conversion in refractory Mycobacterium avium complex lung disease patients up to 12 months. Respiratory side effects were common, but serious kidney or hearing issues were infrequent.

Area of Science:

  • Pulmonology
  • Infectious Diseases
  • Pharmacology

Background:

  • Refractory Mycobacterium avium complex (MAC) lung disease presents limited therapeutic avenues.
  • The CONVERT study demonstrated amikacin liposome inhalation suspension (ALIS) plus guideline-based therapy (GBT) improved culture conversion rates by Month 6.
  • Extended treatment data for refractory MAC patients using ALIS beyond six months are scarce.

Purpose of the Study:

  • To assess the 12-month safety, tolerability, and efficacy of ALIS combined with GBT in adults with refractory MAC lung disease.
  • To evaluate culture conversion rates at 6 and 12 months in patients receiving ALIS+GBT.
  • To analyze the long-term safety profile of ALIS in this patient population.

Main Methods:

  • An open-label extension study (INS-312) enrolled adults with refractory MAC lung disease who did not achieve culture conversion by Month 6 of the CONVERT study.
  • Participants received 590 mg once-daily ALIS plus GBT for an additional 12 months.
  • Two cohorts were analyzed: ALIS-naive (GBT alone in CONVERT) and prior-ALIS (ALIS+GBT in CONVERT).

Main Results:

  • In the ALIS-naive cohort, 33.3% achieved culture conversion by 12 months. Respiratory treatment-emergent adverse events (TEAEs) occurred in 83.3% and serious TEAEs in 35.6%.
  • In the prior-ALIS cohort, 13.7% achieved culture conversion by 12 months. Respiratory TEAEs occurred in 46.6% and serious TEAEs in 27.4%.
  • Nephrotoxicity and hearing decline were infrequent adverse events in both cohorts throughout the study duration (up to 20 months of ALIS exposure).

Conclusions:

  • Amikacin liposome inhalation suspension (ALIS) combined with guideline-based therapy (GBT) demonstrates continued efficacy for culture conversion beyond six months in refractory MAC lung disease.
  • While respiratory adverse events are common with prolonged ALIS use, significant renal or auditory toxicity remains infrequent.
  • These findings support the extended use of ALIS as a therapeutic option for patients with refractory MAC lung disease who have not achieved culture conversion.
Keywords:
ALISMycobacterium aviumamikacin liposome inhalation suspensionculture conversionnontuberculous mycobacteria

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