title: Oral ganciclovir for patients with cytomegalovirus retinitis treated with a ganciclovir implant. Roche Ganciclovir Study Group.
abstract: BACKGROUND
  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.
  
  
  METHODS
  Three hundred seventy-seven patients with AIDS and unilateral cytomegalovirus retinitis were randomly assigned to one of three 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.
  
  
  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 ganciclovir reduced the overall risk of new cytomegalovirus disease by 37.6 percent over the one-year period of the study (P=0.02). 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=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 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's sarcoma.
authors: Department of Ophthalmology, Emory University School of Medicine, Atlanta, GA 30322, USA. dmart04@emory.edu
authors: D F
authors: DF
authors: Martin
authors: B D
authors: BD
authors: Kuppermann
authors: R A
authors: RA
authors: Wolitz
authors: A G
authors: AG
authors: Palestine
authors: H
authors: H
authors: Li
authors: C A
authors: CA
authors: Robinson
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000401:mortality / Q000517:prevention & control; D000284:Administration, Oral; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003586:Cytomegalovirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D017726:Cytomegalovirus Retinitis / Q000188:drug therapy* / Q000401:mortality / Q000517:prevention & control; D018450:Disease Progression; D004343:Drug Implants; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D007275:Injections, Intravenous; D008297:Male; D011480:Protease Inhibitors / Q000627:therapeutic use; D012306:Risk; D012514:Sarcoma, Kaposi / Q000453:epidemiology / Q000517:prevention & control; D016019:Survival Analysis
chemical_list: D000998:Antiviral Agents; D004343:Drug Implants; D011480:Protease Inhibitors; D015774:Ganciclovir