Oral ganciclovir for cytomegalovirus retinitis in patients with AIDS: results of two randomized studies.

OBJECTIVE

To determine the relative effectiveness of an oral formulation compared to a standard intravenous regimen of ganciclovir in preventing the progression of cytomegalovirus (CMV) retinitis in patients with AIDS.

DESIGN

Two randomized, multicenter 20-week studies of standard intravenous ganciclovir maintenance therapy compared with 3000 mg/day or oral ganciclovir.

METHODS

Patients randomized to receive intravenous ganciclovir (5 mg/kg per day) or oral ganciclovir (500 mg six times a day), or to receive intravenous ganciclovir (5 mg/kg per day) or one of two regimens of oral ganciclovir (500 mg six times a day or 1000 mg three times/day).

PATIENTS: AIDS patients with newly diagnosed CMV retinitis or who had CMV retinitis treated previously with intravenous ganciclovir for more than 4 weeks, but less than 4 months. MAIN OUTCOME AND MEASURE(S): Primary endpoints were times to first progression of retinitis, time to the occurrence of one or more prospectively observed, severe and dose-limiting adverse events, or 20 weeks. Visual assessments every 2 weeks included indirect ophthalmologic examination (funduscopy), photographs (bilateral, full 9- or 12-field photographs), and Snellen visual acuity assessments.

RESULTS

Mean times to progression for intravenous ganciclovir by photographic assessment were 62 days and 66 days, and for oral ganciclovir mean times were 57 days and 54 days. The differences in mean time to progression (oral minus intravenous) was -5 days and -12 days. In the funduscopic assessment, both the mean time to progression and the differences in mean time to progression were longer in both treatment groups. Neutropenia was more common in the intravenous than in the oral ganciclovir treatment groups, but no significant differences were found in other laboratory parameters.

CONCLUSIONS

CMV retinitis progression occurs a mean of 5-12 days sooner with oral ganciclovir than with intravenous ganciclovir maintenance treatment. Oral ganciclovir is an effective alternative to intravenous ganciclovir for maintenance therapy of CMV retinitis in patients with AIDS.