Title: A Trial of Itraconazole or Amphotericin B for HIV-Associated Talaromycosis

Le, T et al.


What You Need to Know:

For human immunodeficiency virus (HIV)-infected adults with talaromycosis, initial treatment with amphotericin was found to be superior compared to itraconazole “with respect to 6-month mortality, clinical response, and fungicidal activity.”

Trial Design:

  • Open-label, noninferiority study compared itraconazole to amphotericin B in the treatment of talaromycosis
  • 440 patients HIV-infected adults with talaromycosis were randomized to receive amphotericin B deoxycholate (n=219) administered intravenously or itraconazole (n=221) administered orally for 14 days; all patients then received itraconazole maintenance therapy
  • Primary endpoint: all-cause mortality at week 2
  • Secondary endpoints: “all-cause mortality at week 24, the time to clinical resolution of talaromycosis, early fungicidal activity, relapse of talaromycosis, development of the immune reconstitution inflammatory syndrome (IRIS), and the side-effect profile”

Key Outcomes:

  • Risk of death at week 2: 6.5% for amphotericin patients vs 7.4% for itraconazole patients (absolute risk difference: 0.9%; 95% CI: -3.9, 5.6; P<0.001 for noninferiority)
  • Risk of death at week 24: 11.3% for amphotericin patients vs 21.0% for itraconazole patients (absolute risk difference: 9.7%; 95% CI: 2.8, 16.6; P=0.006)
  • Amphotericin-treated patients showed faster clinical resolution and fungal clearance, decreased rates of relapse, and lower rates of IRIS compared to itraconazole-treated patients
  • Amphotericin associated with “significantly higher rates of infusion-related reactions, renal failure, hypokalemia, hypomagnesemia, and anemia than patients in the itraconazole group”