title: Efficacy and safety of leflunomide for the treatment of BK virus-associated hemorrhagic cystitis in allogeneic hematopoietic stem cell transplantation recipients.
abstract: BK virus-associated hemorrhagic cystitis (BKV-HC) is a severe complication after allogeneic hematopoietic stem cell transplantation. So far, no specific antiviral drug with proven efficacy has been approved for treating BKV-HC. Leflunomide is an immunosuppressive drug with antiviral activity and has been used in treating BKV-associated nephropathy after renal transplantation. This is the first report on the efficacy and safety of leflunomide in the treatment of BKV-HC. From January 2006 to January 2009, 89 patients received allogeneic hematopoietic stem cell transplantation, and among them, 18 patients were identified as having BKV-HC, with a 20% cumulative incidence. Fourteen patients were treated with oral leflunomide. Three days of 100 mg/day leflunomide was used as loading doses and followed by maintenance doses of 20 mg/day. The urinary BKV-DNA load was monitored weekly by real-time quantitative PCR. The efficacy was evaluated on day 20 after leflunomide treatment. Seven patients (50%) achieved complete remission, 5 patients (35.7%) achieved partial remission, and 2 patients (14.3%) had more than a 1-log reduction in urinary BKV-DNA loads after treatment. During the leflunomide treatment, the graft-versus-host disease of the patients did not progress, and the dosages of the immunosuppressant were reduced simultaneously. One patient discontinued treatment because of intolerable gastrointestinal symptoms. Neutropenia occurred in 2 cases. These preliminary data suggest that leflunomide may be a potentially effective medication for treating BKV-HC without significant toxicity, but evidence supporting its use requires randomized controlled trials.
authors: Division of Hematology, Department of Internal Medicine, West China Hospital, Sichuan University, Chengdu, PR China.
authors: Xin-Chuan
authors: XC
authors: Chen
authors: Ting
authors: T
authors: Liu
authors: Jian-Jun
authors: JJ
authors: Li
authors: Chuan
authors: C
authors: He
authors: Weng-Tong
authors: WT
authors: Meng
authors: Rui
authors: R
authors: Huang
mesh_terms: D000328:Adult; D001739:BK Virus; D003556:Cystitis / Q000188:drug therapy* / Q000821:virology; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006470:Hemorrhage / Q000188:drug therapy / Q000821:virology; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage* / Q000009:adverse effects; D000077339:Leflunomide; D008297:Male; D008875:Middle Aged; D027601:Polyomavirus Infections / Q000150:complications*; D014412:Tumor Virus Infections / Q000150:complications*; D019562:Viral Load; D055815:Young Adult
chemical_list: D004791:Enzyme Inhibitors; D007555:Isoxazoles; D000077339:Leflunomide