THE NEW ENGLAND JOURNAL OF MEDICINE
Oral Ganciclovir for Patients With Cytomegalovirus Retinitis Treated With a Ganciclovir Implant
Daniel F. Martin, MD; Baruch D. Kuppermann, MD, PhD; Richard A. Wolitz, MD; Alan G. Palestine, MD; Hong Li, MS; Charles A. Robinson, MD; and the Roche Ganciclovir Study Group
The intraocular ganciclovir implant is effective for local treatment of cytomegalovirus retinitis in patients with the acquired immunodeficiency syndrome (AIDS), but it does not treat or prevent other systemic manifestations of cytomegalovirus infection.
Three hundred seventy-seven patients with AIDS and unilateral cytomegalovirus retinitis were randomly assigned to 1 of 3 treatments: a ganciclovir implant plus oral ganciclovir (4.5 g daily), a ganciclovir implant plus oral placebo, or intravenous ganciclovir alone. The primary outcome measure was the development of new cytomegalovirus disease, either contralateral retinitis or biopsy-proved extraocular disease.
The incidence of new cytomegalovirus disease at 6 months was 44.3% in the group assigned to the ganciclovir implant plus placebo, as compared with 24.3% in the group assigned to the ganciclovir implant plus oral ganciclovir (P = .002) and 19.6% in the group assigned to intravenous ganciclovir alone (P<.001). As compared with placebo, oral ganciclovir reduced the overall risk of new cytomegalovirus disease by 37.6% over the 1-year period of the study (P = .02). However, in the subgroup of 103 patients who took protease inhibitors, the rates of new cytomegalovirus disease were low and of similar magnitude, regardless of treatment assignment. Progression of retinitis in the eye that initially received an implant was delayed by the addition of oral ganciclovir, as compared with placebo (P = .03). Treatment with oral or intravenous ganciclovir reduced the risk of Kaposi sarcoma by 75% (P = .008) and 93% (P<.001), respectively, as compared with placebo.
In patients with AIDS and cytomegalovirus retinitis, oral ganciclovir in conjunction with a ganciclovir implant reduces the incidence of new cytomegalovirus disease and delays progression of the retinitis. Treatment with oral or intravenous ganciclovir also reduces the risk of Kaposi sarcoma.
Holland GN. Treatment Options for Cytomegalovirus RetinitisA Time for Reassessment. Arch Ophthalmol. 1999;117(11):1549-1550. doi:10.1001/archopht.117.11.1549