ORAL GANCICLOVIR AS MAINTENANCE TREATMENT FOR CYTOMEGALOVIRUS RETINITIS IN PATIENTS WITH AIDS

Background. Cytomegalovirus retinitis, a sight threatening infection a ssociated with the acquired immunodeficiency syndrome (AIDS), currentl y requires lifelong intravenous treatment. An effective oral treatment would bean important advance. Methods. We compared oral with intraven ous ganciclovir in an open-label, randomized study in patients with AI DS and newly diagnosed, stable cytomegalovirus retinitis (the disease was stabilized by three weeks of treatment with intravenous ganciclovi r). Sixty subjects were randomly assigned to maintenance therapy with intravenous ganciclovir at a dose of 5 mg per kilogram of body weight daily, and 63 to maintenance therapy with oral ganciclovir at a dose o f 3000 mg daily. The subjects were followed for up to 20 weeks, with p hotography of the fundi conducted every other week. The photographs we re evaluated at the completion of the study by an experienced grader w ho was unaware of the subjects' treatment assignments. Results. Effica cy could be evaluated in 117 subjects; photographs were ungradable for 2 of the 117. On the basis of the masked assessment of photographs fr om 115 subjects, the mean time to the progression of retinitis was 62 days in those given intravenous ganciclovir and 57 days in those given oral ganciclovir (P=0.63; relative risk [oral vs. intravenous], 1.08; 95 percent confidence interval for the difference in means, -22 to +1 2 days). On the basis of funduscopy by ophthalmologists who were aware of the subjects' treatment assignments, the mean time to progression was 96 days in subjects given intravenous ganciclovir and 68 days in s ubjects given oral ganciclovir (P=0.03; relative risk [oral vs. intrav enous], 1.68; 95 percent confidence interval for the difference in mea ns, -45 to -11 days). Survival, changes in visual acuity, the incidenc e of viral shedding, and the incidence of adverse gastrointestinal eve nts were similar in the two groups. Neutropenia, anemia, intravenous-c atheter-related adverse events, and sepsis were more common in the gro up given intravenous ganciclovir. Conclusions. Oral ganciclovir is saf e and effective as maintenance therapy for cytomegalovirus retinitis a nd is more convenient for patients to take than intravenous ganciclovi r.