A randomized trial of ganciclovir versus ganciclovir plus immune globulin for prophylaxis against Epstein-Barr virus related posttransplant lymphoproliferative disorder.
BACKGROUND
Transplant recipients who are Epstein-Barr virus (EBV)-seronegative and receive organs from seropositive donors (EBV D+/R-) are at increased risk for posttransplant lymphoproliferative disorder (PTLD) and may benefit from antiviral prophylaxis. We performed a multi-center trial assessing two different antiviral regimens and their effect on EBV replication.


METHODS
EBV D+/R- solid organ transplant recipients were randomized to receive either ganciclovir and placebo or ganciclovir and immunoglobulin (IG) for 3 months. Following this, patients were unblinded and IG patients received additional IG therapy until 6 months. EBV viral loads were done at least monthly. RESULTS.: Thirty-four patients (25 pediatric, 9 adult) completed the protocol (16 placebo; 18 IG). The incidence of a detectable viral load within the first year posttransplant was 13/16 (81.3%) in the ganciclovir arm vs. 13/18 (72.2%) in the ganciclovir and IG arm (P=0.8). Time to first detectable viral load, and time to high-level viral load were not significantly different. By repeated measures ANOVA analysis, and by estimation of viral load AUC, no significant effect of randomization group was observed on EBV viral loads. PTLD developed in 3 (8.8%) patients (all in IG arm; P=0.23).


CONCLUSIONS
No significant difference in EBV viral load suppression was observed when ganciclovir was compared with ganciclovir and IG in high-risk EBV D+/R- patients.
Humar
Atul
A
Transplant Infectious Diseases, University of Toronto, and University Health Network, Toronto General Hospital, 585 University Avenue, Toronto, Ontario, Canada M5G 2N2. atul.humar@uhn.on.ca
Hébert
Diane
D
Davies
H Dele
HD
Humar
Abhinav
A
Stephens
Derek
D
O'Doherty
Brenda
B
Allen
Upton
U
D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003586:Cytomegalovirus Infections / Q000517:prevention & control; D020031:Epstein-Barr Virus Infections / Q000517:prevention & control*; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage / Q000627:therapeutic use*; D004854:Herpesvirus 4, Human / Q000302:isolation & purification; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage*; D007223:Infant; D008232:Lymphoproliferative Disorders / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D016377:Organ Transplantation / Q000009:adverse effects*; D019562:Viral Load
D000998:Antiviral Agents; D007136:Immunoglobulins; D015774:Ganciclovir