Valganciclovir prophylaxis in patients at high risk for the development of cytomegalovirus disease.
BACKGROUND
Despite advances in antiviral therapies, cytomegalovirus (CMV) remains the leading opportunistic infection in the transplant population. Valganciclovir (VGC), the L-valyl ester prodrug of ganciclovir (GCV), provides an excellent oral alternative to GCV for the prevention of CMV in transplant recipients. We investigated the use of VGC for CMV prevention in high-risk renal and pancreas transplant recipients.


METHODS
Patients at high risk for development of CMV disease were defined as either those who had donor positive, recipient-negative serostatus (D+/R-), or those who received antilymphocyte antibody (ALA) therapy for either rejection treatment or induction. A retrospective review was conducted of all kidney and pancreas transplants performed between August 2001 and December 2003. A total of 341 transplants were performed, of which 109 received VGC, and 88 were included in this analysis.


RESULTS
The overall incidence of CMV disease was 5.7% (5/88). All of the CMV episodes were in patients who were D+/R- (17.2% [5/29] versus 0% [0/59], P<0.001). Of these patients, all the episodes of CMV were in patients who received VGC prophylaxis for<100 days post transplant (29% [5/17] versus 0% [0/12], P=0.06). The overall incidence of leukopenia was 11% and thrombocytopenia was 7%, with the incidence between the D+/R- group and the ALA group being similar.


CONCLUSIONS
VGC is an effective agent in preventing CMV disease in kidney and pancreas transplant recipients who are at high risk for developing the disease. The optimal length of prophylaxis in D+/R- patients is still undefined, while 3 months of prophylaxis appears to be sufficient in patients who received ALA therapy.
Taber
D J
DJ
Wingate University School of Pharmacy, Wingate, North Carolina 28174, USA. dtaber@wingate.edu
Ashcraft
E
E
Baillie
G M
GM
Berkman
S
S
Rogers
J
J
Baliga
P K
PK
Rajagopalan
P R
PR
Lin
A
A
Emovon
O
O
Afzal
F
F
Chavin
K D
KD
D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D000961:Antilymphocyte Serum / Q000627:therapeutic use; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D003586:Cytomegalovirus Infections / Q000276:immunology / Q000517:prevention & control*; D004347:Drug Interactions; D005260:Female; D015774:Ganciclovir / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D006801:Humans; D016030:Kidney Transplantation / Q000276:immunology; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections / Q000517:prevention & control*; D016035:Pancreas Transplantation / Q000276:immunology; D012189:Retrospective Studies; D012307:Risk Factors; D013921:Thrombocytopenia / Q000139:chemically induced; D000077562:Valganciclovir
D000914:Antibodies, Viral; D000961:Antilymphocyte Serum; D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir