Efficacy and safety of Amphotericin B Lipid Complex Injection (ABLC) in solid-organ transplant recipients with invasive fungal infections

• Published in: Clinical transplantation Vol. 14; no. 4; pp. 329 - 339
• Main Authors: Linden, Peter, Williams, Penny, Chan, Kevin M
• Format: Journal Article
• Language: English
• Published: Copenhagen Munksgaard International Publishers 01.08.2000; Blackwell
• Subjects: Adolescent; Adult; Aged; amphotericin B; Amphotericin B - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antifungal agents; Antifungal Agents - therapeutic use; Biological and medical sciences; Child; Drug Combinations; efficacy; Female; fungal infection; Humans; Kidney - drug effects; Kidney - physiology; liposome complex; Male; Medical sciences; Middle Aged; Mycoses - drug therapy; Mycoses - mortality; Organ Transplantation; Pharmacology. Drug treatments; Phosphatidylcholines - therapeutic use; Phosphatidylglycerols - therapeutic use; Postoperative Complications - drug therapy; Postoperative Complications - mortality; Retrospective Studies; safety; solid-organ transplantation; Survival Rate; Human; Mycosis; Toxicity; Treatment efficiency; Lipids; Transplantation; Homotransplantation; Infection; Antibiotic; Antifungal agent; Chemotherapy; Treatment; Amphotericin B; Polyenic compound; Surgery; Dissemination; Severity score; Organ
• ISSN: 0902-0063; 1399-0012
• DOI: 10.1034/j.1399-0012.2000.140409.x

Background: Fungal infections following solid‐organ transplantation are a major source of morbidity and mortality. This report describes the efficacy and safety of Amphotericin B Lipid Complex Injection (ABLC) in solid‐organ transplant recipients. 
Methods: Three open‐label, second‐line treatment studies evaluated ABLC as a treatment for severe, life‐threatening mycoses in patients who were refractory to or intolerant to conventional antifungal (mostly amphotericin B [AmB]) therapy or had pre‐existing renal disease. 
Results: The 79 solid‐organ transplant recipients (25 heart, 20 liver, 17 kidney, 11 lung, 5 multiple, 1 pancreas) who received ABLC in these studies had the following fungal infections: aspergillosis (n=39); candidiasis (n=20); zygomycosis (n=8); cryptococcosis and histoplasmosis (n=3 each); and blastomycosis, cladosporiosis, fusariosis, Bipolaris hawaiiensis, Dactylaria gallopava, and an unspecified fungal infection (n=1 each). The median duration of ABLC therapy was 28 d (1–178 d). The daily dose ranged between 1.6 and 7.4 mg/kg (median, 4.6 mg/kg). The clinical response rate for the patients who could be assessed was 58% (39/67). Clinical response rates for heart, liver, kidney, and lung recipients were 59, 60, 67, and 40%, respectively; response rates for aspergillosis and candidiasis were 47 and 71%, respectively. Forty‐six of the 79 patients (58%) survived for more than 28 d after the last dose of ABLC. Mean baseline serum creatinine was 3.2 mg/dL; 64 patients (81%) had stable (n=37) or improved (n=27) serum creatinine at the end of treatment. 
Conclusions: ABLC is safe and effective treatment for fungal infections in solid‐organ transplant recipients. Its renal‐sparing properties are particularly suited for this high‐risk population for renal failure.