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Amikacin liposome inhalation suspension as a treatment for patients with refractory mycobacterium avium complex lung
Yang Zhang1, Adam T Hill1,2
1Centre for Inflammation Research, Centre for Inflammation Research at the University of Edinburgh, Queen's Medical Research Institute, Edinburgh BioQuarter, Edinburgh, Scotland.
Abstract:
Introduction: Amikacin liposome inhalation suspension (ALIS) contains amikacin sulfate, an aminoglycoside antibacterial drug. It has been approved in the US as a combined antibiotic treatment for refractory MAC lung disease patients. ALIS, as an inhaled antibiotic, can deliver amikacin to the infected site effectively and reduce systemic toxicity.Areas covered: This article gives a summated review of the pharmacodynamics, pharmacokinetics, therapeutic efficacy, post-marketing surveillance, and regulatory affairs of ALIS as an add-on therapy for MAC lung disease in adults by analyzing data from preclinical studies, clinical trials and original studies. We systematically searched Medline/PubMed through October 2020.Expert opinion: Studies demonstrate that ALIS as an add-on treatment significantly improve the rate of sputum culture conversion in MAC lung disease patients compare to guideline-recommended therapy only. The ALIS treatment showed a similar risk of serious adverse events and a low chance of renal adverse events. However, ALIS was associated with more respiratory adverse events than guideline-recommended therapy only. There was not sufficient data to conclude that ALIS treatment can improve clinical outcomes; however, with the significant improvement in the microbiology outcome in MAC lung disease patients, ALIS showed its potential use as an adjunct treatment for treating MAC lung disease.
Insights
Amikacin liposome inhalation suspension (ALIS) improves sputum culture conversion in MAC lung disease patients. While generally safe, ALIS may increase respiratory side effects but shows potential as an adjunctive therapy.
Area of Science:
- Pulmonology
- Infectious Diseases
- Pharmacology
Background:
- Amikacin liposome inhalation suspension (ALIS) is an inhaled antibiotic approved for refractory Mycobacterium Avium Complex (MAC) lung disease.
- Inhaled antibiotics like ALIS target infections directly, potentially reducing systemic toxicity.
Purpose of the Study:
- To review the pharmacodynamics, pharmacokinetics, efficacy, safety, and regulatory aspects of ALIS as an add-on therapy for adult MAC lung disease.
- To analyze data from preclinical, clinical, and post-marketing studies.
Main Methods:
- Systematic literature search of Medline/PubMed up to October 2020.
- Analysis of preclinical studies, clinical trials, and original research on ALIS.
- Review of post-marketing surveillance and regulatory information.
Main Results:
- ALIS as add-on therapy significantly improved sputum culture conversion rates compared to guideline-recommended therapy alone.
- ALIS demonstrated a similar risk of serious adverse events and low renal adverse event rates.
- Respiratory adverse events were more frequent with ALIS compared to guideline-recommended therapy alone.
Conclusions:
- ALIS shows significant microbiological benefits in MAC lung disease patients.
- While clinical outcome data is limited, ALIS holds potential as an adjunctive treatment for MAC lung disease.
- Further research may be needed to fully elucidate clinical outcome improvements.
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