Amikacin Liposomal Inhalation Suspension for Non-Tuberculous Mycobacteria Lung Infection: A Greek Observational Study

Abstract

Background and Objectives: Intravenous amikacin, recommended for severe or recurrent M. avium complex (MAC) infections and as initial treatment for M. abscessus lung disease, is often limited by serious adverse effects such as renal and auditory toxicities. Inhaled Amikacin Liposome Inhalation Suspension (ALIS) enhances pulmonary drug deposition while minimizing systemic adverse effects, and it has recently been introduced as an add-on therapy for refractory MAC infections or when other standard treatments are inadequate. This study aims to retrospectively describe the outcomes of Greek patients with difficult-to-treat non-tuberculous mycobacterial (NTM) lung disease following the addition of ALIS to guideline-based therapy. Materials and Methods: Seventeen consecutive patients (median age: 66 years) treated with ALIS as an add-on therapy to a standard regimen at "Sotiria" General Hospital of Chest Diseases (Athens, Greece) from 2020 to 2023 were enrolled in this study. These patients had recurrent or refractory NTM lung disease and/or limited treatment options due to prior treatment-related adverse effects. Clinical, radiological, and microbiological data on treatment response and overall outcomes after ALIS initiation were recorded for each patient. Results: By the end of 2023, 14 out of 17 patients had either successfully completed or were continuing their ALIS therapy. At 6 months, 85.7% (12/14) showed clinical, microbiological, and radiological improvement. However, 25% (3/12) of treated patients, primarily those with monomicrobial or combined M. abscessus lung disease, experienced disease relapse after therapy completion. The most frequent adverse effects related to ALIS were mild and localized to the respiratory tract, with only one patient discontinuing therapy due to hypersensitivity pneumonitis. Conclusions: Adding ALIS to standard regimens was effective and safe in a small group of Greek patients with refractory or recurrent NTM lung disease, particularly those who had discontinued intravenous aminoglycosides due to significant adverse effects, with notable responses observed in MAC lung disease. Further research is needed to validate these findings in clinical practice and to investigate ALIS's role in NTM lung disease caused by other species.

Keywords: Mycobacterium abscessus; Mycobacterium avium complex; aminoglycoside; inhalation; liposome; mycobacterial infections.

Figure 1

Radiological improvement of patients on treatment with ALIS for NTM-LD. Six months after ALIS initiation, all patients with MAC-associated LD (Panels (A–D)) and some patients with M. abscessus-LD (Panels (E,F) presented an improvement in CT findings such as nodules (red circles) and consolidations (green circles). (ALIS: Amikacin liposomal inhalation suspension, MAC: M. avium complex, NTM: non-tuberculous mycobacteria, LD: lung disease).

Figure 2

Radiological relapse in a patient with M. abscessus LD during treatment with ALIS. A patient with M. abscessus-associated LD showed remarkable clinical and radiological improvement (green circle) after 6 months on treatment with ALIS (Panels (A–D)). However, a few months later, he had symptom recurrence and a new infiltrate (red circle) at a different segment of the right upper lobe (Panels (E,F)). (LD: lung disease).