Abstract | 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.
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Authors | Oliver Witzke, Ingeborg A Hauser, Michael Bartels, Gunter Wolf, Heiner Wolters, Martin Nitschke, VIPP Study Group |
Journal | Transplantation
(Transplantation)
Vol. 93
Issue 1
Pg. 61-8
(Jan 15 2012)
ISSN: 1534-6080 [Electronic] United States |
PMID | 22094954
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiviral Agents
- Valganciclovir
- Ganciclovir
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Topics |
- Administration, Oral
- Adult
- Aged
- Antiviral Agents
(administration & dosage, adverse effects, therapeutic use)
- Austria
- Cytomegalovirus Infections
(drug therapy, epidemiology, prevention & control)
- Dose-Response Relationship, Drug
- Female
- Follow-Up Studies
- Ganciclovir
(administration & dosage, adverse effects, analogs & derivatives, 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
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