Risk Factors for Human Papilloma Virus Reactivation in the Genital Tract of Female Stem Cell Transplant Survivors

s / Biol Blood Marrow Transplant 22 (2016) S19eS481 S26 Methods: This was a phase 3, multicenter, open-label, randomized, controlled trial in patients 5% weight gain). Patients were randomized to standard care with or without DF prophylaxis (25 mg/kg/day, 4 divided 6.25 mg/kg infusions). Osteopetrosis was a stratification variable. DF began the same day as conditioning, continuing for 30 days post-SCT or 14 days for patients discharged from hospital before day +30 post-SCT. Control patients developing VOD/ SOS received DF treatment. Primary endpoint: day +30 incidence of VOD/SOS post-SCT. Results: The intent-to-treat population included 356 patients: 180 randomized to DF prophylaxis and 176 in the control group. Mean (SD) age: 6.6 (5.3) years. 40.7% of patients were female. Demographic and clinical characteristics were well-matched. Most common risk factors: busulfan/melphalan conditioning (58%) and preexisting liver disease (27%). VOD/SOS occurred by day +30 post-SCT in 22 (12%) patients in the DF prophylaxis group vs 35 (20%) in the control group. Rates of VOD/SOS in osteopetrosis patients were 14% in the DF prophylaxis arm vs 67% in the control arm. VOD/SOS rates by day +30 were reduced by 50% in the DF arm vs the control arm in patients with hemophagocytic lymphohistiocytosis (0%, 40%), second myeloablative transplantation (8%, 17%), and prior gemtuzumab treatment (18%, 40%, respectively). Differences in VOD/SOS rates were lowest for adrenoleukodystrophy (ALD, no cases) and prior abdominal irradiation (11% vs 13%, respectively). The overall AE incidence was similar between patients receiving defibrotide prophylaxis (80%) and control arm patients (80%). Conclusions: Across risk-factor subgroups, the rate of VOD/ SOS was lower in patients receiving DF compared with controls (except ALD: no VOD/SOS in either group). Although the total numbers of patients with these risk factors were small, these between-group differences are of clinical interest and should be further explored. Support Jazz Pharmaceuticals