Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS

Stephen A. Spector, George F. Mckinley, Jacob P. Lalezari, Tobias Samo, Robert Andruczk, Stephen Follansbee, Paula D. Sparti, Diane V. Havlir, Gail Simpson, William Buhles, Rodney Wong, Mary Jean Stempien

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291 Scopus citations

Abstract

Background. In the advanced stages of the acquired immunodeficiency syndrome (AIDS), cytomegalovirus (CMV) disease, particularly vision-damaging retinitis due to CMV, is common. We evaluated prophylactic treatment with orally administered ganciclovir as a way to prevent CMV disease. Methods. We conducted a prospective, randomized, double-blind, placebo-controlled study of CMV-infected persons with AIDS with either CD4+ lymphocyte counts of ≤50 per cubic millimeter or counts of ≤100 per cubic millimeter in those with a history of an AIDS-defining opportunistic infection. Patients were randomly assigned, in a 2:1 ratio, to receive either oral ganciclovir (1000 mg three times daily) or placebo. Results. The study was stopped 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) and14 percent in the ganciclovir group (n = 486), representing an overall reduction in risk of 49 percent in the ganciclovir group (P<0.001). The incidence of CMV retinitis after 12 months was 24 percent in the placebo group and 12 percent in the ganciclovir group (P<0.001). The prevalence of CMV-positive urine cultures at base line was 42 percent; after two months it was 43 percent 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 granulocyte colony-stimulating factor was more frequent in the ganciclovir group (24 percent) than in the placebo group (9 percent). Conclusions. In persons with advanced AIDS, prophylactic oral ganciclovir significantly reduces the risk of CMV disease.

Original languageEnglish
Pages (from-to)1491-1497
Number of pages7
JournalNew England Journal of Medicine
Volume334
Issue number23
DOIs
StatePublished - 6 Jun 1996
Externally publishedYes

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