title: Prospective comparison of valacyclovir and oral ganciclovir for prevention of cytomegalovirus disease in high-risk renal transplant recipients.
abstract: To compare the efficacy, costs and safety of oral ganciclovir and valacyclovir in the prophylaxis of cytomegalovirus (CMV) disease in renal transplant (RTx) recipients at high risk of CMV disease.
  
  
  
  A total of 83 patients were prospectively randomized to 3-month treatment with either oral ganciclovir (3 g/day) or oral valacyclovir (8 g/day). A 3rd group received no prophylaxis. Forty-nine patients were considered to be at high risk of CMV disease due to D+R- serologic status, OKT3/ATG treatment and/or acute rejection within 12 months after RTx. Twenty-three high-risk patients were treated with ganciclovir (GAN group), 17 patients with valacyclovir (VAL group), and 9 patients received no prophylaxis (C group).
  
  
  
  No significant differences were found among the groups in their demographic characteristics, immunosuppressive protocols, D/R CMV serology, or CMV risk factors. The 12-month incidence of CMV disease was 89% in the C group compared with 9% in the GAN group and 6% in the VAL group (p < 0.001, GAN or VAL vs. C; p = 0.713, GAN vs. VAL). Treatment failure (death, graft loss, CMV disease or withdrawal from study) occurred in 17, 6, and 89% in the GAN, VAL, and C groups, respectively (p < 0.001, GAN or VAL vs. C; p = 0.285, GAN vs. VAL). The average CMV-associated costs per patient were EUR 3,161, 3,757, and 7,247 in the GAN, VAL, and C groups, respectively (p = 0.027).
  
  
  
  Valacyclovir and oral ganciclovir are equally effective in the prophylaxis of CMV disease in high-risk RTx patients. Both regimens are cost-effective and help reduce CMV-associated costs by nearly 50% compared with patients without prophylaxis.
authors.affiliation: Department of Internal Medicine I, Charles University School of Medicine and University Hospital, Pilsen, Czech Republic. reischig@fnplzen.cz
authors.forename: Tomás
authors.initials: T
authors.lastname: Reischig
authors.forename: Karel
authors.initials: K
authors.lastname: Opatrný
authors.forename: Vladislav
authors.initials: V
authors.lastname: Treska
authors.forename: Jan
authors.initials: J
authors.lastname: Mares
authors.forename: Pavel
authors.initials: P
authors.lastname: Jindra
authors.forename: Miroslava
authors.initials: M
authors.lastname: Svecová
mesh_terms: D000212:Acyclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000284:Administration, Oral; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003586:Cytomegalovirus Infections / Q000191:economics / Q000401:mortality / Q000517:prevention & control*; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage* / Q000009:adverse effects; D006084:Graft Rejection / Q000188:drug therapy; D006085:Graft Survival; D017048:Health Care Costs; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000191:economics / Q000517:prevention & control / Q000821:virology; D011446:Prospective Studies; D012307:Risk Factors; D000077483:Valacyclovir; D014633:Valine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D014766:Viremia / Q000191:economics / Q000401:mortality / Q000517:prevention & control
chemical_list: D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D014633:Valine; D000077483:Valacyclovir; D015774:Ganciclovir; D000212:Acyclovir