Trial reportCell transplantation
Impact of posaconazole tablets for secondary prophylaxis on drug interactions in haploidentical allogeneic stem cell transplantation: A single-arm, open-label, prospective study.
Trial report in Cell transplantation. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
3 authors.
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Abstract
Posaconazole (POS) tablets were approved for prophylaxis of invasive fungal disease (IFD) in patients with hematological disorders undergoing haploidentical allogeneic stem cell transplantation (haplo-HSCT). There is limited research on drug-drug interactions (DDIs) between POS, cyclosporine A (CsA), and mycophenolate mofetil (MMF), as well as the impact of POS on acute graft versus host disease (aGVHD) in haplo-HSCT patients receiving POS for secondary antifungal prophylaxis (SAP). This study aims to investigate the DDI between POS, CsA, and MMF, as well as the incidence of aGVHD in haplo-HSCT patients with prior-IFD. This is a single-arm, open-label, prospective trial. Plasma concentrations of POS, mycophenolic acid (MPA), and CsA were monitored within 30 days post-transplantation. In addition, the incidences of aGVHD and IFD were observed. Forty-six patients with prior-IFD were enrolled. POS reached a steady state by week 2, with the mean through blood concentration (TBC) of 0.54 ± 0.07 μg/mL. MPA achieved target levels by week 3 without dose adjustment, with a mean TBC of 0.84 ± 0.08 mg/L. The CsA TBC levels required individualized dose modifications. The incidences of grade II-IV and grade III-IV aGVHD were 47.83% and 21.74%, respectively. The breakthrough rate of SAP was 4.35% at 100 days and 10.86% at 6 months. The conclusions indicate that POS tablets do not require dose adjustments for MMF; however, CsA dosing must be individualized. POS tablets appear to be effective and well-tolerated for SAP in haplo-HSCT (the Chinese Clinical Trial Registry: www.chictr.org.cn (ChiCTR2200059472)).
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