Valganciclovir prophylaxis versus preemptive therapy in cytomegalovirus-positive renal allograft recipients: 1-year results of a randomized clinical trial

Transplantation. 2012 Jan 15;93(1):61-8. doi: 10.1097/TP.0b013e318238dab3.


Background: Cytomegalovirus (CMV) prevention can be achieved by prophylaxis or preemptive therapy. We performed a prospective randomized trial to determine whether renal transplant recipients with a positive CMV serostatus (R+) had a higher rate of CMV infection and disease after transplantation when treated preemptively for CMV infection, compared with primary valganciclovir prophylaxis.

Methods: Prophylaxis was 2 × 450 mg oral valganciclovir/day for 100 days; preemptive patients were monitored by CMV-polymerase chain reaction (PCR), and after a positive PCR test received 2 × 900 mg valganciclovir/day for at least 14 days followed by secondary prophylaxis. Valganciclovir dosage was adjusted according to renal function. Patients are followed up for 5 years and initial 12-month data are presented. Two hundred and ninety-six recipients were analyzed (168 donor/recipient seropositive [D+/R+], 128 donor seronegative/recipient seropositive [D-/R+]; 146 receiving prophylaxis and 150 preemptive therapy).

Results: Overall, CMV infection (asymptomatic CMV viral load ≥ 400 CMV DNA copies/mL proven by CMV-PCR) was significantly higher in recipients under preemptive therapy (38.7% vs. 11.0%, P<0.0001), with the highest incidence in D+/R+ preemptive patients (53.8% vs. 15.6%, P<0.0001). D+/R+ recipients with preemptive therapy also had the highest rate of CMV disease (CMV syndrome and tissue-invasive disease that was clinically diagnosed and biopsy proven) (19.2% vs. 4.4%, P=0.003). Renal function assessed by creatinine clearance was similar for both groups. Graft loss occurred in 7 vs. 4 patients on preemptive versus prophylactic therapy (P>0.05). Tolerability was similar for both treatment groups.

Conclusions: Oral valganciclovir prophylaxis significantly reduces CMV infection and disease, particularly for D+/R+ patients. Hence, our study supports routine prophylaxis for all D+/R+ recipients.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Austria
  • Cytomegalovirus Infections / drug therapy*
  • Cytomegalovirus Infections / epidemiology
  • Cytomegalovirus Infections / prevention & control*
  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Ganciclovir / administration & dosage
  • Ganciclovir / adverse effects
  • Ganciclovir / analogs & derivatives*
  • Ganciclovir / therapeutic use
  • Germany
  • Graft Rejection / physiopathology
  • Graft Survival / physiology
  • Humans
  • Incidence
  • Kidney Transplantation* / physiology
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Prospective Studies
  • Retrospective Studies
  • Transplantation*
  • Transplantation, Homologous
  • Treatment Outcome
  • Valganciclovir


  • Antiviral Agents
  • Valganciclovir
  • Ganciclovir