Cytomegalovirus antigenemia directed pre-emptive prophylaxis with oral versus i.v. ganciclovir for the prevention of cytomegalovirus disease in livertransplant recipients - A randomized, controlled trial

Background. The efficacy of pre-emptively administered oral ganciclovir in preventing cytomegalovirus (CMV) disease has not been documented in liver t ransplant recipients. We sought to compare the efficacy of pre-emptive oral ganciclovir with that of i.v. ganciclovir for the prevention of CMV diseas e after liver transplantation, and to determine whether withholding prophyl axis in the absence of CMV antigenemia, reliably identified patients in who m no prophylaxis was necessary. Methods. Surveillance cultures for CMV pp65 antigenemia were performed in a ll patients at weeks 2, 4, 6, 8, 12, and 16, Patients with CMV antigenemia were randomized into two study groups, The experimental group received oral ganciclovir for 6 weeks (2 g t.i.d. for 2 weeks, then 1 g t.i.d. for 4 wee ks), and the control group received i.v. ganciclovir (5 mg/kg q 12 hr) for 7 days. Results. Of 72 consecutive liver transplant recipients studied, CMV antigen emia occurred in 31% (22 of 72), Twenty-two patients with asymptomatic anti genemia were randomized to two study groups, CMV disease (viral syndrome) o ccurred in 9% (1 of 11) of the patients in the i,v, ganciclovir group and i n 0% (0 of 11) of the patients in the oral ganciclovir group. None of the s tudy patients developed tissue invasive CMV disease. The median reduction i n antigenemia level with oral ganciclovir was 55% at week 1, and 100% at we ek 2, Overall, 64% of the patients by week 1, 93% by week 2, and 100% by we ek 4 had antigenemia levels below the baseline after oral ganciclovir. Of 5 0 patients without CMV antigenemia, none developed CMV disease. Conclusions. Pre-emptive prophylaxis based on CMV antigenemia can effective ly target the patients for CMV prophylaxis; 69% of the patients never recei ved antiviral prophylaxis and did not develop CMV disease. Antiviral therap y instituted upon detection of antigenemia prevented tissue invasive CMV in both ganciclovir groups. Pre-emptively administered oral ganciclovir was e ffective as prophylaxis for CMV disease after liver transplantation.