title: A prospective evaluation of leflunomide therapy for cytomegalovirus disease in renal transplant recipients.
abstract: OBJECTIVE
  A preliminary observation suggests leflunomide is effective in the treatment of cytomegalovirus (CMV) disease in renal transplant recipients. A prospective evaluation was conducted in renal transplant recipients to study the efficacy of leflunomide in the treatment of CMV disease.
  
  
  METHODS
  With prior approval and informed consent for therapy and follow-up, 17 consecutive consenting renal transplant recipients with proven CMV disease were treated with leflunomide. CMV disease was defined as a clinical syndrome of fever and/or symptoms of organ involvement, leukopenia, and a positive nested CMV quantitative PCR test at 0.001 microg/5 microL template input, with or without histologic evidence of tissue invasion. Leflunomide metabolite concentrations (A77 1726) were monitored.
  
  
  RESULTS
  Of the 17 patients, 14 patients were treated for 6 months for CMV disease the first time; the remaining 3 received leflunomide treatment for relapse after ganciclovir treatment, for a year. Seven patients had fever with viremia and no organ involvement, nine had viremia with involvement of gastrointestinal tract, and one had fever with CMV inclusions in the allograft, with no demonstrable viremia. The three patients with relapse treated with leflunomide responded. Overall, 15 patients (88%) clinically responded to leflunomide therapy and with viral clearance from blood and healing of involved organs. The cost of therapy with intravenous ganciclovir (Cymevene, Roche) for 2 weeks was US 721 dollars while that of leflunomide (Cleft, Cipla Ltd) for 6 months was US 64 dollars.
  
  
  CONCLUSIONS
  Leflunomide treatment for CMV disease in renal transplant recipients is effective, simple, and economical.
authors.affiliation: Christian Medical College, Department of Nephrology, Vellore, Tamil Nadu, India. gtjt@hotmail.com
authors.forename: G T
authors.initials: GT
authors.lastname: John
authors.forename: J
authors.initials: J
authors.lastname: Manivannan
authors.forename: S
authors.initials: S
authors.lastname: Chandy
authors.forename: S
authors.initials: S
authors.lastname: Peter
authors.forename: D H
authors.initials: DH
authors.lastname: Fleming
authors.forename: S J
authors.initials: SJ
authors.lastname: Chandy
authors.forename: N
authors.initials: N
authors.lastname: Balakrishnan
authors.forename: K
authors.initials: K
authors.lastname: Krishnamurthy
authors.forename: M G
authors.initials: MG
authors.lastname: Kirubakaran
authors.forename: C K
authors.initials: CK
authors.lastname: Jacob
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use; D003586:Cytomegalovirus Infections / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000627:therapeutic use*; D016030:Kidney Transplantation; D000077339:Leflunomide; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000188:drug therapy* / Q000821:virology*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D007555:Isoxazoles; D000077339:Leflunomide