Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
Comparison of Early Fungicidal Activity and Mortality Between Daily Liposomal Amphotericin B and Daily Amphotericin B Deoxycholate for Cryptococcal Meningitis.
СтатьяСравнительное исследованиеПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Kimuda Sarah, Kwizera Richard, Dai Biyue, Kigozi Enos, Kasozi Derrick, Rutakingirwa Morris K, Tukundane Asmus, Shifah Nabbaale, Luggya Tony, Luswata Andrew, Ndyetukira Jane Frances, Yueh Spencer L, Mulwana Suzan, Wele Abduljewad, Bahr Nathan C, Meya David B, Boulware David R, Skipper Caleb P
Аннотация
BACKGROUND: Limited data exist on the antifungal activity of daily liposomal amphotericin B with flucytosine induction regimens for cryptococcal meningitis, which are recommended in high-income countries. Liposomal amphotericin B monotherapy at 3 mg/kg previously failed to meet noninferiority criteria compared to amphotericin B deoxycholate in its registrational clinical trial. We aimed to compare the quantitative antifungal activity and mortality between daily amphotericin B deoxycholate and daily liposomal amphotericin B among persons with human immunodeficiency virus (HIV)-related cryptococcal meningitis receiving adjunctive flucytosine 100 mg/kg/day.
METHODS: We analyzed data from 3 clinical studies involving participants with HIV-associated cryptococcal meningitis receiving either daily liposomal amphotericin B at 3 mg/kg/day with flucytosine (n = 94) or amphotericin B deoxycholate at 0.7-1.0 mg/kg/day with flucytosine (n = 404) as induction therapy. We compared participant baseline characteristics, cerebrospinal fluid (CSF) early fungicidal activity (EFA), and 10-week mortality.
RESULTS: We included 498 participants in this analysis, of whom 201 had available EFA data (n = 46 liposomal amphotericin B; n = 155 amphotericin B deoxycholate). Overall, there is no statistical evidence that the antifungal activity of liposomal amphotericin B (mean EFA, 0.495 [95% confidence interval {CI}, .355-.634] log10 colony-forming units [CFU]/mL/day) differ from amphotericin B deoxycholate (mean EFA, 0.402 [95% CI, .360-.445] log10 CFU/mL) (P = .13). Mortality at 10 weeks trended lower for liposomal amphotericin B (28.2%) versus amphotericin B deoxycholate (34.6%) but was not statistically different when adjusting for baseline characteristics (adjusted hazard ratio, 0.74 [95% CI, .44-1.25]; P = .26).
CONCLUSIONS: Daily liposomal amphotericin B induction demonstrated a similar rate of CSF fungal clearance and 10-week mortality as amphotericin B deoxycholate when combined with flucytosine for the treatment of HIV-associated cryptococcal meningitis.
METHODS: We analyzed data from 3 clinical studies involving participants with HIV-associated cryptococcal meningitis receiving either daily liposomal amphotericin B at 3 mg/kg/day with flucytosine (n = 94) or amphotericin B deoxycholate at 0.7-1.0 mg/kg/day with flucytosine (n = 404) as induction therapy. We compared participant baseline characteristics, cerebrospinal fluid (CSF) early fungicidal activity (EFA), and 10-week mortality.
RESULTS: We included 498 participants in this analysis, of whom 201 had available EFA data (n = 46 liposomal amphotericin B; n = 155 amphotericin B deoxycholate). Overall, there is no statistical evidence that the antifungal activity of liposomal amphotericin B (mean EFA, 0.495 [95% confidence interval {CI}, .355-.634] log10 colony-forming units [CFU]/mL/day) differ from amphotericin B deoxycholate (mean EFA, 0.402 [95% CI, .360-.445] log10 CFU/mL) (P = .13). Mortality at 10 weeks trended lower for liposomal amphotericin B (28.2%) versus amphotericin B deoxycholate (34.6%) but was not statistically different when adjusting for baseline characteristics (adjusted hazard ratio, 0.74 [95% CI, .44-1.25]; P = .26).
CONCLUSIONS: Daily liposomal amphotericin B induction demonstrated a similar rate of CSF fungal clearance and 10-week mortality as amphotericin B deoxycholate when combined with flucytosine for the treatment of HIV-associated cryptococcal meningitis.