ORAL GANCICLOVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN PERSONS WITH AIDS

Background. In the advanced stages of the acquired immunodeficiency sy ndrome (AIDS), cytomegalovirus (CMV) disease, particularly vision-dama ging retinitis due to CMV, is common. We evaluated prophylactic treatm ent with orally administered ganciclovir as a way to prevent CMV disea se. Methods. We conducted a prospective, randomized, double-blind, pla cebo-controlled study of CMV-infected persons with AIDS with either CD 4+ lymphocyte counts of less than or equal to 50 per cubic millimeter or counts of less than or equal to 100 per cubic millimeter in those w ith a history of an AIDS-defining opportunistic infection. Patients we re randomly assigned, in a 2:1 ratio, to receive either oral ganciclov ir (1000 mg three times daily) or placebo. Results. The study was stop ped after a median of 367 days of follow-up. In an intention-to-treat analysis, the 12-month cumulative rates of confirmed CMV disease were 26 percent in the placebo group (n=239) and 14 percent in the ganciclo vir group (n=486), representing an overall reduction in risk of 49 per cent in the ganciclovir group (P<0.001). The incidence of CMV retiniti s after 12 months was 24 percent in the placebo group and 12 percent i n the ganciclovir group (P<0.001). The prevalence of CMV-positive urin e cultures at base line was 42 percent; after two months it was 43 per cent in the placebo group and 10 percent in the ganciclovir group (P<0 .001). The one-year mortality rate was 26 percent in the placebo group and 21 percent in the ganciclovir group (P=0.14). Therapy with granul ocyte colony-stimulating factor was more frequent in the ganciclovir g roup (24 percent) than in the placebo group (9 percent). Conclusions. In persons with advanced AIDS, prophylactic oral ganciclovir significa ntly reduces the risk of CMV disease. (C) 1996, Massachusetts Medical Society.