Study: CytoGam Disappoints as Therapy for Pediatric Liver Recipients

Researchers report that a drug they hoped might prevent Post-Transplant Lymphoproliferative Disease (PTLD) in children who have had liver transplants has proven a disappointment.

The drug CytoGam, an intravenous immune globulin enriched in antibodies against cytomegalovirus, had been used in trials since 1995 in an effort to keep pediatric transplant recipients from developing PTLD, a complication associated with the Epstein-Barr Virus (EBV).

Children who receive transplants are particularly vulnerable to the Epstein-Barr Virus because the immunosuppressive drugs they take to prevent organ rejection also impair their ability to fight this infection.

Researchers from the University of Pittsburgh School of Medicine said they initiated a multicenter trial that eventually enrolled nearly 90 children to study the effectiveness of CytoGam in preventing PTLD.

But the researchers reported at the annual scientific meeting of the American Society of Transplantation that two years after transplantation, the incidence of PTLD was 8 percent in the children who received CytoGam versus 16 percent in those receiving a placebo -- a difference they did not view as statistically significant.

"In the current era, with more vigilant screening taking place, there does not appear to be any benefit for the use of the drug CytoGam, or any other drug, for that matter, for the prevention of EBV-associated PTLD in our pediatric liver transplant recipients," Dr. Michael Green said.

At the University of Pittsburgh, doctors now intensively monitor pediatric liver transplant recipients during the first six months after transplant, and if elevations in the EBV viral load are detected, carefully reduce immunosuppression until the viral load falls or until there are early signs of rejection.

This way, the patient's immune system is given the chance to effectively deal with the Epstein-Barr Virus without the risk of developing PTLD, the researchers added..

Other Sources: University of Pittsburgh