Durability of culture conversion in patients receiving ALIS for treatment-refractory MAC lung disease

Compared with guideline-based therapy (GBT) alone, amikacin liposome inhalation suspension (ALIS) plus GBT was associated with significantly higher rates of sustained culture conversion (up to 16 months) on therapy and durable sputum culture conversion 3 months post-treatment [1].

In a late-breaking oral session, Prof. David Griffith (University of Texas Health Science Center, USA) reported the longer-term results from the ongoing, randomised, open-label, phase 3 CONVERT study of ALIS in patients with refractory Mycobacterium avium complex (MAC) lung disease. The addition of ALIS to GBT eliminated evidence of MAC infection in sputum by month 6 in 29.0% of patients, compared with 8.9% of patients on GBT alone (P<0.0001). The new data presented in this session showed that among patients who achieved culture conversion by month 6, 80.0% (52/65) of those receiving ALIS plus GBT sustained culture conversion for up to 12 months of treatment after the first dose that defined culture conversion, compared with 30.0% (3/10) of patients receiving GBT alone (P=0.0014). Three months after the completion of treatment, 63.1% (41/65) of patients receiving ALIS plus GBT maintained durable culture conversion, compared with 0.0% (0/10) of patients receiving GBT alone (P=0.0002).

No new safety signals were associated with continued ALIS use in the study. Treatment-emergent adverse events (AEs) were reported by 98.2% of patients who received ALIS plus GBT and by 91.1% of patients who received GBT alone. The most common treatment-emergent AEs were dysphonia (46.6% for patients receiving ALIS plus GBT vs 1.8% for GBT alone), cough (38.1% vs 15.2%), dyspnoea (21.5% vs 8.9%), and haemoptysis (18.4% vs 14.3%). Serious treatment-emergent AEs occurred in 20.2% of patients who received ALIS plus GBT and in 20.5% of patients who received GBT alone.

"These longer-term findings from the CONVERT study suggest that the culture conversion achieved by many patients during the first 6 months of taking ALIS combined with GBT could be maintained throughout the course of therapy," said Prof. Griffith. "Importantly, the data also suggest that many patients who complete the full course of therapy may be able to maintain durable culture conversion 3 months off all treatment, which would be an important advance in the treatment of refractory MAC lung disease."

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   1. Griffith DE, et al. A7359, ATS 2019, 17-22 May, Dallas, Texas, USA.

Posted on 23 July, 201923 March, 2021