Oral ganciclovir for patients with cytomegalovirus retinitis treated with a ganciclovir implant

Background The intraocular ganciclovir implant is effective for local treat ment of cytomegalovirus retinitis in patients with the acquired immunodefic iency syndrome (AIDS), but it does not treat or prevent other systemic mani festations of cytomegalovirus infection. Methods Three hundred seventy-seven patients with AIDS and unilateral cytom egalovirus retinitis were randomly assigned to one of three treatments: a g anciclovir implant plus oral ganciclovir (4.5 g daily), a ganciclovir impla nt plus oral placebo, or intravenous ganciclovir alone. The primary outcome measure was the development of new cytomegalovirus disease, either contral ateral retinitis or biopsy-proved extraocular disease. Results The incidence of new cytomegalovirus disease at six months was 44.3 percent in the group assigned to the ganciclovir implant plus placebo, as compared with 24.3 percent in the group assigned to the ganciclovir implant plus oral ganciclovir (P=0.002) and 19.6 percent in the group assigned to intravenous ganciclovir alone (P<0.001). As compared with placebo, oral gan ciclovir reduced the overall risk of new cytomegalovirus disease by 37.6 pe rcent over the one-year period of the study (P=0.02). However, in the subgr oup of 103 patients who took protease inhibitors, the rates of new cytomega lovirus 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 p lacebo (P=0.03). Treatment with oral or intravenous ganciclovir reduced the risk of Kaposi's sarcoma by 75 percent (P=0.008) and 93 percent (P<0.001), respectively, as compared with placebo. Conclusions In patients with AIDS and cytomegalovirus retinitis, oral ganci clovir in conjunction with a ganciclovir implant reduces the incidence of n ew cytomegalovirus disease and delays progression of the retinitis. Treatme nt with oral or intravenous ganciclovir also reduces the risk of Kaposi's s arcoma. (N Engl J Med 1999;340:1063-70.) (C) 1999, Massachusetts Medical So ciety.