Intravenous versus oral ganciclovir: European/Australian comparative study of efficacy and safety in the prevention of cytomegalovirus retinitis recurrence in patients with AIDS. The Oral Ganciclovir European and Australian Cooperative Study Group.

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.