Objectives: To evaluate the efficacy and safety of oral ganciclovir for the maintenance treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.
Design: A 20-week, randomized, multicentre, open-label study. Progression of retinitis was assessed by funduscopy and masked reading of fundus photographs.
Methods: Adult patients with AIDS and stable CMV retinitis following a 2-3 week induction course of intravenous ganciclovir (5 mg/kg every 12 h) were randomized 2:1 to receive maintenance therapy with oral ganciclovir 500 mg six times daily, or 5 mg/kg intravenous ganciclovir once daily infused over 1 h. The primary efficacy variable was time to progression of CMV retinitis from initiation of maintenance therapy.
Results: A total of 159 patients were enrolled; 112 received oral ganciclovir and 47 intravenous ganciclovir. By masked assessment of fundus photographs, CMV retinitis progressed in 72% of patients in the oral group and 76% in the intravenous group. Mean time to progression was 51 days with oral ganciclovir and 62 days with intravenous ganciclovir (P = 0.15). By funduscopy, CMV retinitis progressed in 59% of oral ganciclovir patients and 43% of intravenous ganciclovir patinets. Mean time to progression was 86 and 109 days, respectively (P = 0.02). Diarrhoea and neutropenia (absolute neutrophil count < 500 x 10(6)/l) were the most frequently reported adverse events in both groups. The incidence of spesis for the oral and intravenous ganciclovir patients was 3 and 8.5%, respectively. Infection at the intravenous site occurred in 0 and 9% of patients, respectively.
Conclusions: Oral ganciclovir offers an effective and safe alternative to intravenous ganciclovir in the maintenance therapy of CMV retinitis.