Posaconazole as good as voriconazole for treatment of invasive aspergillosis: Lancet
Delhi: Posaconazole can be used as a first-line treatment for people with invasive aspergillosis, finds a recent study in the journal Lancet. According to the study, posaconazole is non-inferior to voriconazole for mortality up until day 42 in people with this condition and was well tolerated. Also, participants in the posaconazole group had fewer adverse events related to the treatment than in the voriconazole group.
Voriconazole is recommended as primary treatment for invasive aspergillosis patients. Tablet and intravenous formulations of posaconazole having improved systemic absorption could be an effective alternative to voriconazole. Prof Johan A Maertens, University Hospitals Leuven, Leuven, Belgium, and colleagues aimed to assess non-inferiority of posaconazole to voriconazole for the primary treatment of invasive aspergillosis.
For the purpose, the researchers performed a randomized, prospective, double-blind, double-dummy, controlled trial that compared posaconazole with voriconazole for 12 weeks or less in the primary treatment of invasive aspergillosis. 653 individuals assessed for eligibility, 575 ITT participants were randomly assigned and received one or more doses of study drug (n=288 [50%] posaconazole, n=287 [50%] voriconazole).
The primary endpoint was cumulative all-cause mortality up until day 42 in the intention-to-treat (ITT) population (defined as randomly assigned participants who received ≥1 dose of study drug), with a 10% non-inferiority margin. The ITT population was also evaluated for safety.
Key findings of the study include:
- Mortality up until day 42 was 15% (44 of 288) in the posaconazole group and 21% (59 of 287) in the voriconazole group.
- Mortality up until day 42 in the full-analysis-set subpopulation (ITT participants with proven or probable invasive aspergillosis) supported this conclusion: 31 (19%) of 163 participants in the posaconazole group and 32 (19%) of 171 participants in the voriconazole group.
- The most frequently reported treatment-related adverse events (incidence >3%) were increased aspartate aminotransferase (AST) or alanine aminotransferase (ALT), nausea, hypokalaemia, and vomiting in the posaconazole group and increased ALT, AST, or alkaline phosphatase, hallucination, increased γ-glutamyltransferase peptidase, nausea, and blurred vision in the voriconazole group.
- The overall incidence of treatment-related adverse event rates in the ITT population was 30% for posaconazole and 40% for voriconazole.
"Posaconazole was non-inferior to voriconazole for all-cause mortality up until day 42 in participants with invasive aspergillosis. Posaconazole was well tolerated, and participants had fewer treatment-related adverse events than in the voriconazole group," wrote the authors.
"This study supports the use of posaconazole as a first-line treatment for the condition," they concluded.
The study titled, "Posaconazole versus voriconazole for primary treatment of invasive aspergillosis: a phase 3, randomised, controlled, non-inferiority trial," is published in the journal Lancet.
DOI: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00219-1/fulltext
