At 12 weeks it can prevent symptomatic disease better than preemptive therapy, study says.


CHICAGO—Twelve weeks of cytomegalovirus (CMV) prophylaxis may work better than preemptive therapy in preventing CMV disease in pancreas transplant recipients who are CMV positive preoperatively.

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Spanish investigators at the University Hospital 12 de Octubre of Madrid re-viewed data on 83 pancreas transplant patients seen at their institution be-tween 1995 and 2006. The mean age of the patients was 40 years and 65% were female. All patients received previous or simultaneous kidney transplants.


The clinicians employed three different strategies for CMV disease prophylaxis in CMV seropositive recipients. Group 1 (10 subjects) received IV ganciclovir for the first few days (range 3-15 days) and received antithymocyte globulin (most of them for less than 10 days). Group 2 (13 subjects) received ganciclovir while receiving antithymocyte globulin and preemptive therapy based on CMV pp65 antigenemia for the first six months after transplant. Group 3 (29 subjects) received prophylaxis for 12 weeks with IV ganciclovir or oral valganciclovir or both. A separate group of 20 subjects, who were CMV seronegative pretransplant, received prolonged 12-week prophylaxis in addition to IV ganciclovir or oral valganciclovir. A total of 11 subjects were excluded because their transplanted pancreas was removed in the first 15 days.


The incidence of CMV disease was 30% for Group 1 (three of 10 subjects), 23% for Group 2 (three of 13 subjects) and 6.9% for Group 3 (two of 29 subjects). CMV disease developed in both patients in Group 3 after finishing prophylaxis. The CMV disease rate was 35% (seven of 20 subjects) for the CMV pre-transplant seronegative group. CMV disease developed in four of these seven subjects more than 12 weeks post-transplantation, after prophylaxis had ended. There were no major complications or deaths related to CMV disease.


“With the patients who are seronegative prior to transplant, even with 12 weeks of intravenous ganciclovir or oral valganciclovir, they still have very high risk for CMV disease,” said investigator Francisco Lopez-Medrano, MD, PhD, an infectious disease specialist and associate professor of medicine. He presented findings here at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.


The data suggest that preemptive therapy should not be recommended in this patient population. “We think continuous prophylaxis with IV ganciclovir or oral valganciclovir is the best strategy, and this should be done for at least 12 weeks and possibly longer,” said Dr. Lopez-Medrano. “This is really the first comparative study of its kind. It was designed to give us a better idea of what works best.”