Prospective comparison of valacyclovir and oral ganciclovir for prevention of cytomegalovirus disease in high-risk renal transplant recipients.
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.
Reischig
Tomás
T
Department of Internal Medicine I, Charles University School of Medicine and University Hospital, Pilsen, Czech Republic. reischig@fnplzen.cz
Opatrný
Karel
K
Treska
Vladislav
V
Mares
Jan
J
Jindra
Pavel
P
Svecová
Miroslava
M
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
D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D014633:Valine; D000077483:Valacyclovir; D015774:Ganciclovir; D000212:Acyclovir