title: 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.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of oral ganciclovir for the maintenance treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.
  
  
  METHODS
  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.
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000517:prevention & control*; D000284:Administration, Oral; D000328:Adult; D001315:Australia; D017726:Cytomegalovirus Retinitis / Q000517:prevention & control*; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D004341:Drug Evaluation; D005060:Europe; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015774:Ganciclovir