A randomized prospective trial of oral versus intravenous ganciclovir for prophylaxis of cytomegalovirus infection and disease in high-risk kidney recipients.
OBJECTIVE
This study was designed to compare the efficacy and safety of oral versus intravenous ganciclovir in high-risk kidney recipients.


METHODS
Thirty-four, cytomegalovirus (CMV) seropositive recipients of kidneys from seropositive donors who had undergone antilymphocytic immunosuppressive therapy were assigned randomly to oral (1000 mg, three times a day, 12 weeks) versus intravenous (5 mg/kg, 2 weeks) ganciclovir prophylaxis. Follow-up was performed for 12 months. The patients were evaluated for clinical and laboratory outcomes regarding CMV serostatus, CMV disease, graft outcome, and ganciclovir side effects.


RESULTS
Sixteen patients in the oral group and 14 in the intravenous group completed the study. CMV infection occurred in 6 (37.5%) and 5 (35.7%) cases in the oral and intravenous groups, respectively (P = NS). The mean interval between prophylaxis initiation and the first positive CMV Ag result was 3 +/- 2.19 months, with no significant difference between the two groups. Only two patients in the intravenous group experienced CMV diseases, which were not tissue-invasive. Acute rejection episodes were observed in nine out of 30 recipients, but it did not show any association with the prophylaxis regimen or CMV serostatus. The patients tolerated oral ganciclovir well; the compliance percent was 81.6%. No complication was reported.


CONCLUSIONS
Oral and intravenous ganciclovir showed no significant difference to reduce the rate of CMV infection among high-risk kidney recipients. Oral ganciclovir was also effective and safe for the prevention of CMV disease. Moreover, it seems that CMV infection was not associated with acute rejection episodes.
Nafar
M
M
National Research Center of Medical Sciences, Ministry of Health and Medical Education, Iran. nafarm@hbi.or.ir
Pezeshki
M Lessan
ML
Farrokhi
F
F
Einollahi
B
B
Pour-Reza-Gholi
F
F
Firouzan
A
A
Farhangi
S
S
D000284:Administration, Oral; D000961:Antilymphocyte Serum / Q000627:therapeutic use; D003586:Cytomegalovirus Infections / Q000517:prevention & control*; D015774:Ganciclovir / Q000008:administration & dosage / Q000627:therapeutic use*; D006084:Graft Rejection / Q000188:drug therapy / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007275:Injections, Intravenous; D007668:Kidney / Q000821:virology; D016030:Kidney Transplantation / Q000502:physiology*; D007958:Leukocyte Count; D011183:Postoperative Complications / Q000517:prevention & control / Q000821:virology*; D014019:Tissue Donors
D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents; D015774:Ganciclovir