title: Valacyclovir for cytomegalovirus prophylaxis reduces the risk of acute renal allograft rejection.
abstract: BACKGROUND
  Both oral ganciclovir and valacyclovir decrease the incidence of cytomegalovirus (CMV) disease after renal transplantation. Moreover, valacyclovir has been shown to reduce the risk of acute rejection. Our study was designed to compare the efficacy and safety of oral ganciclovir and valacyclovir in the prophylaxis of CMV disease after renal transplantation.
  
  
  METHODS
  A total of 83 patients were prospectively randomized to 3-month treatment with oral ganciclovir (3 g/day, n=36, GAN) or oral valacyclovir (8 g/day, n=35, VAL). A control group (DEF, n=12) was managed by deferred therapy.
  
  
  RESULTS
  No differences were found in demography, immunosuppression, or donor/recipient CMV serology. The 12-month incidence of CMV disease was 67% in the DEF group compared with 6% in the GAN group and 3% in the VAL group (P<0.001 GAN or VAL vs. DEF; P=0.575 GAN vs. VAL). The biopsy-confirmed acute rejection rate at 12 months was 12% in the VAL group compared with 34% in the GAN group (P=0.030) and 58% in the DEF group (P<0.001). The difference between the GAN and DEF groups was not significant (P=0.087). The average CMV-associated costs per patient were $3,072, $2,906, and $4,906 in the GAN, VAL, and DEF groups, respectively.
  
  
  CONCLUSIONS
  Valacyclovir and oral ganciclovir are equally effective in the prevention of CMV disease after renal transplantation. Both regimens are cost-effective. Valacyclovir is associated with a significantly reduced risk of acute rejection compared with both ganciclovir prophylaxis and deferred therapy.
authors.affiliation: Department of Internal Medicine I, Charles University Hospital, Pilsen, Czech Republic. reischig@fnplzen.cz
authors.forename: Tomás
authors.initials: T
authors.lastname: Reischig
authors.forename: Pavel
authors.initials: P
authors.lastname: Jindra
authors.forename: Jan
authors.initials: J
authors.lastname: Mares
authors.forename: Miloslav
authors.initials: M
authors.lastname: Cechura
authors.forename: Miroslava
authors.initials: M
authors.lastname: Svecová
authors.forename: Ondrej
authors.initials: O
authors.lastname: Hes
authors.forename: Karel
authors.initials: K
authors.lastname: Opatrný
authors.forename: Vladislav
authors.initials: V
authors.lastname: Treska
mesh_terms: D000212:Acyclovir / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D003586:Cytomegalovirus Infections / Q000517:prevention & control*; D005260:Female; D015774:Ganciclovir / Q000009:adverse effects / Q000627:therapeutic use*; D006084:Graft Rejection / Q000453:epidemiology / Q000517:prevention & control*; D006650:Histocompatibility Testing; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007674:Kidney Diseases / Q000145:classification / Q000601:surgery; D016030:Kidney Transplantation / Q000401:mortality / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D012086:Reoperation; D012307:Risk Factors; D016019:Survival Analysis; D013997:Time Factors; D014184:Transplantation, Homologous; D000077483:Valacyclovir; D014633:Valine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D014633:Valine; D000077483:Valacyclovir; D015774:Ganciclovir; D000212:Acyclovir