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High-dose weekly liposomal amphotericin b antifungal prophylaxis in patients undergoing liver transplantation: a
Maddalena Giannella1, Giorgio Ercolani, Francesco Cristini
11 Infectious Diseases Unit, Department of Medical and Surgical Sciences, Sant'Orsola Malpighi Hospital, Alma Mater Studiorum University of Bologna, Italy. 2 Liver and Multi-Organ Transplant Unit, Department of Medical and Surgical Sciences, Sant'Orsola Malpighi Hospital, Alma Mater Studiorum University of Bologna, Italy. 3 Anesthesiology Unit, Department of Medical and Surgical Sciences, Sant'Orsola Malpighi Hospital, Alma Mater Studiorum University of Bologna, Italy. 4 Department of Pharmacy, Sant'Orsola Malpighi Hospital, Alma Mater Studiorum University of Bologna, Italy.
Background:
To assess the safety and tolerability of high-dose weekly (10 mg/kg) liposomal amphotericin B (LamB) for antifungal prophylaxis in liver transplantation (LT) recipients with predefined risk factors for invasive fungal infection (IFI), a prospective phase II noncomparative trial was performed at our center over a 4-year period.
Methods:
In the selected LT recipients, LamB was administered weekly until hospital discharge after LT for minimum 2 weeks. Criteria for early discontinuing prophylaxis were: (i) any adverse event (AE); (ii) suspicion of IFI. Safety and tolerability were assessed according to the incidence of grades 3 to 4 AEs based on Common Toxicity Criteria (CTC) classification. Post-LT follow-up was of 180 days.
Results:
Overall, 76 patients were included. Liposomal amphotericin B was started within a median of 1 (interquartile range, 1-4) day after LT. Overall, 66 of 76 (86.8%) patients completed the prophylaxis, 10 discontinued the study protocol: 6 for infusion-related AE, 4 for suspected IFI. Adverse events consisted of five cases of lumbar pain and one case of thoracic pain which occurred after a median of 1.5 (interquartile range, 1-2) LamB infusions. None of the patients reported CTC grades 3 to 4 hypokalemia, three reported CTC grade 3 acute renal injury, none of which were deemed directly attributable to LamB. No drug-drug interactions with immunosuppressive drugs were reported, and no episode of rejection occurred during the prophylaxis. In only two of the four patients with suspected IFI was the diagnosis of invasive candidiasis confirmed.
Conclusion:
Our results suggest high-dose weekly LamB may be a safe prophylactic strategy for high-risk LT recipients.
Insights
High-dose weekly liposomal amphotericin B (LamB) is a safe antifungal prophylaxis for liver transplant (LT) recipients at high risk for invasive fungal infection (IFI). The study found LamB well-tolerated with manageable adverse events.
Area of Science:
- Transplantation Medicine
- Infectious Diseases
- Pharmacology
Background:
- Liver transplantation (LT) recipients with risk factors for invasive fungal infection (IFI) require effective prophylaxis.
- Assessing high-dose weekly liposomal amphotericin B (LamB) safety and tolerability in this population is crucial.
Purpose of the Study:
- To evaluate the safety and tolerability of high-dose weekly LamB (10 mg/kg) as antifungal prophylaxis.
- To determine the efficacy of LamB in preventing IFI in high-risk LT recipients.
Main Methods:
- Prospective phase II noncomparative trial involving 76 LT recipients.
- Weekly LamB administration post-LT until discharge (minimum 2 weeks).
- Safety assessed via Common Toxicity Criteria (CTC) for adverse events (AEs); follow-up to 180 days.
Main Results:
- 86.8% of patients completed LamB prophylaxis; 13.2% discontinued due to AEs or suspected IFI.
- Most AEs were mild (lumbar/thoracic pain); no grade 3-4 hypokalemia.
- Three cases of grade 3 acute renal injury, not directly attributed to LamB; no drug interactions or rejections.
Conclusions:
- High-dose weekly LamB demonstrates a favorable safety profile for high-risk LT recipients.
- LamB appears to be a safe prophylactic strategy in this vulnerable patient group.
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