Efficacy and Safety of Low-Dose Versus Standard-Dose Valganciclovir for Prevention of Cytomegalovirus Disease in Intermediate-Risk Kidney Transplant Recipients.
OBJECTIVE
Prophylaxis for cytomegalovirus infection is highly recommended for kidney transplant recipients. The use of daily 900 mg valganciclovir is the usual prophylactic dose, whereas 450 mg daily is under investigation. We evaluated the outcome of using 2 different doses of valganciclovir prophylaxis for cytomegalovirus infection after kidney transplant.


METHODS
We randomized kidney transplant recipients (1:1) to receive 450 mg daily valganciclovir (group 1) or 900 mg daily valganciclovir (group 2) for the first 6 months after kidney transplant. Serologically, all patients were at moderate risk for cytomegalovirus infection. Patients were studied for incidence of cytomegalovirus disease, leukopenia attacks, rejection episodes, and graft outcomes for 1 year.


RESULTS
Demographic features of group 1 (98 patients) and group 2 (98 patients) were comparable. More than 50% of patients received thymoglobulin induction therapy without difference between the groups. There were more leukopenia attacks in group 2 (P = .03) requiring higher doses of granulocyte colony-stimulating factor (P = .03). Group 2 patients received lower doses of mycophenolate mofetil (P= .04) and required reduced doses of valganciclovir (P = .045). Compared with group 1, the high-dose group developed numerically more rejection episodes (P = .057) and more cytomegalovirus infections requiring full treatment (P = .17). Graft and patient outcomes were satisfactory in both groups.


CONCLUSIONS
Six months of low-dose valganciclovir prophylaxis for intermediate-risk kidney transplant recipients was as effective as high-dose valganciclovir with a better safety profile.
From the Department of Medicine, Hamed Al-Essa Organ Transplantation Centre, Ibn Sina Hospital, Kuwait.
Medhat A
MA
Halim
Torki
T
Al-Otaibi
Osama
O
Gheith
Hani
H
Adel
Ahmed
A
Mosaad
Abu-Atteya
AA
Hasaneen
Zakaria
Z
Zakaria
Yahya
Y
Makkeya
Tarek
T
Said
Prasad
P
Nair
D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003587:Cytomegalovirus / Q000187:drug effects* / Q000276:immunology / Q000472:pathogenicity; D003586:Cytomegalovirus Infections / Q000175:diagnosis / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D004334:Drug Administration Schedule; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D016867:Immunocompromised Host; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D016030:Kidney Transplantation / Q000009:adverse effects*; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections / Q000175:diagnosis / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D000077562:Valganciclovir; D014775:Virus Activation / Q000187:drug effects
D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D000077562:Valganciclovir; D015774:Ganciclovir