Oral ganciclovir safe, effective for children co-infected with CMV and HIV

Ganciclovir prophylaxis substantially reduces cytomegalovirus (CMV) replication in children co-infected with HIV, according to a report published in the December 2000 issue of The Journal of Infectious Diseases. Dr. Lisa M. Frenkel, from the University of Washington, in Seattle, and colleagues explain that according to studies in adults, oral administration of ganciclovir is associated with reduced incidence of neutropenia and bacterial infections compared with intravenous administration.

In the present study, the authors assessed the pharmacokinetics, safety and efficacy of oral ganciclovir in 36 CMV patients, ages 6 months to 16 years, who were severely immunocompromised by HIV infection. According to the paper, administration of 30 mg/kg ganciclovir at 8-hour intervals achieved serum drug levels similar to those used for maintenance treatment of CMV retinitis in adults.

The investigators report that doses between 10 and 50 mg/kg per 8 hours were generally well tolerated. About 20% of patients withdrew from the trial because of intolerance of the large volume of suspension or number of capsules. No patient withdrew because of neutropenia, but four required granulocyte colony-stimulating factor.

The study team notes that CMV recurrence or new-onset disease occurred in seven and three children, respectively. Of the three children with new-onset disease, one developed ganciclovir resistance, another had resistant CMV at the start of the study, and the third had wild-type virus. In light of their findings, the study team concludes that “oral ganciclovir at least 30 mg/kg every 8 hours, either as a suspension prepared in a pharmacy or as capsules, should provide effective prophylaxis of CMV disease in children.”

In interview, Dr. Frenkel said she would not recommend routine use of oral ganciclovir for children with CMV/HIV infection. “Fortunately, treatment of HIV with combinations of antiretroviral drugs appears to result in the improvement or maintenance of sufficient anti-CMV immunity such that CMV disease rarely occurs,” she said. “In severely immunocompromised children, however, I would consider prophylaxis with ganciclovir if they are infected with CMV.”