CMV
infection causes morbidity and mortality after
transplantation. Despite a wide range of prevention strategies among pediatric lung transplant programs, the optimal duration of prophylactic
therapy against CMV
infection in pediatric
lung transplantation is unknown. To assess the feasibility, safety, and short-term efficacy of extending intravenous
ganciclovir administration from six wk duration to 12 wk duration in pediatric lung transplant recipients. An open-label pilot study was performed in primary pediatric lung transplant recipients with donor and/or recipient CMV seropositivity. Intravenous
ganciclovir was given for 12 wk post-
transplantation. Subjects were tracked for protocol completion. Toxicities monitored included renal dysfunction, myelosuppression, gastrointestinal and neurological complications, as well as
infection related to
indwelling catheter placement. Serial CMV levels were measured to determine short-term efficacy of the intervention. Nine of nine subjects enrolled completed the pilot study. Subjects' ages ranged from six to 18 yr. Indications for
lung transplantation included
cystic fibrosis (n = 7),
idiopathic pulmonary hypertension (n = 1), and complex
congenital heart disease with
pulmonary hypertension (n = 1). Seven subjects underwent deceased donor bilateral
lung transplantation and two subjects underwent
heart-lung transplantation. No subjects
had protocol-defined
drug toxicity. No episodes of
neutropenia,
thrombocytopenia, or renal toxicity occurred. Five subjects had
catheter-related infections (three after week 12 of
ganciclovir). Seven of nine subjects had CMV detected by PCR (four prior to
ganciclovir completion) with only one subject having a positive viral culture for CMV
viremia (prior to
ganciclovir completion). No subjects had UL-97 mutation for
ganciclovir resistance detected. The use of prolonged prophylactic administration of
ganciclovir for 12 wk duration is a feasible, safe, and effective treatment to prevent CMV
viremia based on viral culture in at risk pediatric lung transplant recipients. Further clinical studies are underway to determine optimal CMV prevention strategies.