A comparative randomised study of valacyclovir vs. oral ganciclovir for cytomegalovirus prophylaxis in renal transplant recipients.

An open, prospective, randomised study was conducted to compare the safety and efficacy of valacyclovir vs. oral ganciclovir for cytomegalovirus (CMV) prophylaxis in renal transplant recipients. Eighty-three renal transplant recipients were assigned randomly to receive valacyclovir (n=43) or oral ganciclovir (n=40) for the first 3 months after transplantation. Both groups were similar in terms of demographics, primary renal disease, graft source, HLA matching, immunosuppressive therapy and donor-recipient CMV antibody status. CMV infection was diagnosed by detection of virus DNA in plasma with the Amplicor CMV Test. CMV disease was observed in only one patient belonging to the ganciclovir group, who developed enterocolitis 6 months post-transplantation. No difference was observed between the two treatment groups with respect to detection of CMV DNA, virus infections other than CMV, acute rejection episodes, and serum creatinine levels at 3 and 6 months following transplantation. An increased number of bacterial infections was noted in the ganciclovir group (p 0.003). No adverse reactions with either treatment were reported. The estimated cost of valacyclovir treatment was 20% higher than that of ganciclovir treatment. Overall, both valacyclovir and oral ganciclovir were found to be effective and safe for CMV prophylaxis in renal transplant recipients. Decisions regarding prophylactic regimens should include additional criteria, such as cost or possible development of resistance.

Clinical and epidemiological aspects of an enterovirus outbreak in a neonatal unit.

An outbreak of enterovirus infection occurred among neonates in a maternity hospital between July 7 and 22, 1999. Twenty neonates became ill (18 confirmed and two probable), an attack rate of 33%. The incubation period ranged from three to six days (mean, 4.2). The male:female ratio was 11:9 and the mean age at the onset of illness was 5.5 days. All the babies had fever, eight, a maculopapular rash, and six had symptoms of gastroenteritis, 11 developed meningitis. Nineteen neonates required hospitalization for three to seven days, but all were discharged home without sequelae. Enteroviral RNA was detected in all of 18 urines, and 14 cerebrospinal fluid specimens tested. A case-control study was conducted to determine risk factors associated with the outbreak. Rooming in the nursery ward was a significant risk factor (odds ratio=33.35; 95% confidence interval, 3.79-800; P=0.00002). No association was found between illness and other possible risk factors. Appropriate control measures resulted in resolution of the outbreak. Our findings demonstrate the potential for enteroviruses to cause widespread illness among newborns, and emphasize the usefulness of polymerase chain reaction in the early diagnosis of infection, and underline the role of effective control measures in interrupting viral transmission.