Efficacy of amphotericin B encapsulated in liposomes (AmBisome) in the treatment of invasive fungal infections in immunocompromised patients

Abstract

One hundred and twenty-six patients were treated for 137 episodes of fungal infection with liposomal amphotericin B (AmBisome) at 43 investigational centres. Among the patients were 72 with malignancies, 17 organ transplant recipients, 20 patients with immunological disorders and 17 others. AmBisome treatment was instituted after toxicity from previous amphotericin B treatment in 49 cases, nephrotoxicity or renal insufficiency in 40 and failure of previous antifungal treatment in 41. One hundred and eight episodes were clinically evaluable; among these 52 were caused by Candida spp. and 34 by Aspergillus spp. Ninety-nine patients were treated for at least eight days with a maximum dose of 0.7-5 mg/kg/day. Among 64 cases with proven invasive fungal infection 58% were cured. Fungi were eradicated in 35 of 54 (65%) mycologically evaluable cases. The cumulative dose was 3.2 +/- 3.2 (mean +/- S.D.) in cases where fungi were eradicated in comparison with 3.3 +/- 2.3 g in cases where fungi persisted. The eradication rate was 83% for Candida spp. compared with 41% for Aspergillus spp. (P less than 0.01). Among 24 cases with presumptive invasive fungal infections 14 (58%) were cured. Candida spp. were eradicated in seven of ten of these cases. Among 11 cases with superficial fungal infections eight were cured and three improved. Candida spp. were eradicated in four of five patients. It is concluded that AmBisome is an effective antifungal agent in a majority of patients with invasive or superficial fungal infections.

Randomized PCR-based therapy and risk factors for invasive fungal infection following reduced-intensity conditioning and hematopoietic SCT

“…Patients with a positive PCR result were randomized to antifungal treatment with liposomal amphotericin B (Ambisome, Swedish Orphan, Stockholm, Sweden) 21,22 or to no treatment. Liposomal amphotericin B was given at a dose of 3 mg/kg/day for patients with positive PCR for Aspergillus.…”

Eficiência terapêutica das formulações lipídicas de anfotericina B

“…Em alguns estudos, AmBisome foi administrado em indivíduos que não toleraram ou não responderam às doses terapêuticas de AB-DOC (Coker et al, 1991;Hudson, Scott, Warnock,1991;Ringdén et al, 1991;Mills et al, 1994).…”

“…No tratamento de 3 indiví-duos HIV-positivo com meningite criptocócica, apenas um sobreviveu (Coker et al, 1991). A ineficiência desta terapia também foi observada por Ringdén et al (1991) em 27% dos casos de aspergilose ou candidíase invasivas avaliados, sendo que 53% destes morreram por infecção fúngica. Na aspergilose pulmonar, foi necessário o uso de doses 4 vezes maiores de AmBisome para que fossem atingidas concentrações pulmonares terapêuticas de AB (Ringdén et al, 1991).…”

Adverse effects of antifungal therapies in invasive fungal infections: review and meta-analysis

“…Although available commercially outside of the USA for several years, a third product, liposomal AmB, or LAmB (AmBisome; NeXstar Pharmaceuticals/Fujisawa, San Dimas, CA, USA), received FDA approval in 1997. A majority of patients receiving these newer formulations have demonstrated intolerance to AmB or are documented to have Aspergillus infections refractory to AmB conventional therapy [3,[6][7][8][9][10].…”