BERLIN—Prevention of cytomegalovirus (CMV) disease can be achieved either with prophylactic or preemptive use of antiviral agents after kidney transplantation, but prophylaxis is associated with a lower rate of graft loss or death, according to findings presented at the 24th International Congress of The Transplantation Society.
The findings emerged from an ongoing study in which 146 renal transplant recipients were randomized to receive valganciclovir prophylaxis and 150 were randomized to receive preemptive therapy with the drug.
Researchers had published one-year study results in Transplantation (2012;93:61-68) and presented two-year results at the American Transplant Congress in 2011. At the congress, they presented three year results showing no new active CMV infections in either group. At year 3, the preemptive group had more than twice as many uncensored graft losses than the prophylaxis group (17 vs. 8).
“The results showed that at three years the significant benefit for the prophylactic group was preserved with respect to CMV infection/disease,” noted investigator Ingeborg A. Hauser, MD, a nephrologist at the Goethe University Hospital, Medical Clinical III, in Frankfurt. “Our study is ongoing and we aim to determine whether the significant benefits of valganciclovir prophylaxis continue even longer-term not only for CMV infection but also for graft loss and death.”
Prophylaxis in the study consisted of 900 mg/day of oral valganciclovir 100 days post-transplantation. Preemptive patients were monitored with a polymerase chain reaction test to obtain quantitative viral load measurements. If patients became CMV-positive (CMV viral load greater than 400 copies/mL) , they were given 1,800 mg/day of oral valganciclovir for at least 14 days followed by 900 mg oral valganciclovir/day for 28 days. In all patients, dosage was adjusted according to renal function.
Overall, 38.7% of pre-emptive patients and 11.6% of prophylaxis patients had active CMV infections. Dr. Hauser’s team observed most of the CMV infections and the highest rate of CMV disease in the preemptive group who were CMV-positive pre-transplant and who had a CMV-positive donor with 53.9% active CMV infections compared with 16.7% among donor-negative/recipient-positive pairs, and 21.8% versus 5.6% with respect to CMV disease.
The investigators observed 79 acute rejections in 41 preemptive patients and 69 acute rejections in 44 prophylaxis subjects.