1139. Novel Formulation SUBA-itraconazole Prophylaxis in Patients with Hematological Malignancy or Undergoing Allogeneic Stem Cell Transplantation: Follow Up Survival Data.
Session: Poster Abstract Session: Fungi and Parasites in Immunocompromised Patients
Friday, October 5, 2018
Room: S Poster Hall
  • IDweek 2018 Novel Formulation SUBA_ itraconazole Prophylaxis in Hematological Malignancy or Undergoing Allogeneic Stem Cell Transplantation_ Follow Up Survival Data (2).pdf (731.9 kB)
  • Background: Despite the advantageous spectrum of activity of itraconazole, it is rarely used as a prophylactic agent due to limited bioavailability and intolerance of the conventional formulation. After the development of a novel formulation SUBA-itraconazole® (SUper BioAvailability), we undertook a study to assess therapeutic levels, safety, tolerability and IFI rates of this novel formulation when compared to the conventional itraconazole liquid in patients undergoing allogeneic hematopoietic stem cell transplantation or in hematological malignancy patients.

    Methods: Following a single centre, prospective study of SUBA-itraconazole 200mg BID vs conventional liquid itraconazole 200mg BID, the SUBA-itraconazole group was assessed one year post allogeneic stem cell transplant for incidence of IFI and survival.

    Results: A total of 57 patients (29 SUBA-itraconazole and 30 liquid-itraconazole) were assessed. Therapeutic concentrations were achieved significantly more quickly in the SUBA-itraconazole group; median of 6 days vs 14 (p <0.0001). At day 10, therapeutic concentrations were achieved in 69% of the SUBA-itraconazole group vs 21% (p<0.0001). The mean trough serum concentrations at steady state of SUBA-itraconazole were significantly higher, with less interpatient variability (1577ng/mL, CV 35%) vs (1218ng/mL, CV 60%) (p<0.001). There were 2 (7.5%) treatment failures in the SUBA-itraconazole group, both due to cessation of therapy for mucositis, compared to 7 (23.3%) treatment failures in the liquid-itraconazole group, due to subtherapeutic levels (5), mucositis (1) and gastrointestinal intolerance (1), (p = 0.096). There was one confirmed IFI in the SUBA-itraconazole treatment failure group defined by a blood culture that yielded yeast; however, this was after the cessation of SUBA-itraconazole for mucositis. No other Probable/Possible IFIs were observed. After one year post allogeneic stem cell transplant in the SUBA-itraconazole group there were 2 deaths (10%) due to disease progression and no further IFIs were reported.

    Conclusion: The use of the SUBA-itraconazole formulation was a safe and effective prophylactic agent. It was associated with more rapid attainment of therapeutic levels with less interpatient variability when compared to conventional liquid itraconazole.

    Julian Lindsay, BPharm(Hons), MClinPharm1, Indy Sandaradura, MD2, Kelly Wong, PhD1, Chris Arthur, MBBS1, William Stevenson, MBBS, PhD1, Ian Kerridge, MBBS1, Keith Fay, MBBS1, Luke Coyle, MBBS1 and Matthew Greenwood, MBBS1, (1)Royal North Shore Hospital, Sydney, Australia, (2)St Vincents Hospital, Sydney, Australia


    J. Lindsay, Mayne Pharma: Consultant , Consulting fee .

    I. Sandaradura, None

    K. Wong, None

    C. Arthur, None

    W. Stevenson, None

    I. Kerridge, None

    K. Fay, None

    L. Coyle, None

    M. Greenwood, None

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 3rd with the exception of research findings presented at the IDWeek press conferences.