As many as 90 percent of patients with acquired immunodeficiency syndrome have evidence of cytomegalovirus infection, especially cytomegalovirus retinitis, on autopsy. Although ganciclovir and foscarnet, two antiviral agents, are approved for the treatment of some cytomegalovirus-related conditions, they necessitate long-term intravenous treatment, an impractical procedure unacceptable to many patients. Oral ganciclovir is effective therapy in patients with AIDS who have newly diagnosed and recurrent cytomegalovirus retinitis. In a prospective randomized double-blind, placebo-controlled clinical trial, Spector and colleagues evaluated the efficacy of oral ganciclovir as a prophylactic treatment in the prevention of cytomegalovirus disease in patients with AIDS.
The study included over 725 patients with AIDS and cytomegalovirus infection. All of the patients either had human immunodeficiency virus (HIV) infection and CD4+ lymphocyte counts that were 50 cells or less per [mm.sup.3] or had an opportunistic infection and CD4+ counts of more than 100 cells per [mm.sup.3]. Cytomegalovirus infection was confirmed by antibody test or urine culture.
Two-thirds of the group (486 patients) were randomized to receive 239 mg of ganciclovir three times daily, and 239 received placebo for approximately one year. Twelve-month cumulative rates of confirmed cytomegalovirus disease were 14 percent in the patients receiving ganciclovir, compared with 26 percent in the patients receiving placebo. This represented an overall risk reduction of 26 percent in the patients receiving ganciclovir. The incidence of cytomegalovirus retinitis after 12 months was 12 percent in the ganciclovir group and 24 percent in the placebo group. The prevalence of cytomegalovirus-positive cultures at baseline was 44 percent in the placebo group and 41 percent in the ganciclovir group; after two months, it was 43 percent in the placebo group and 10 percent in the ganciclovir group.
At 12 months, the mortality rate was percent in the placebo group and 21 percent in the ganciclovir group. The primary cause of death in both groups was progressive HIV-related disease. Few severe adverse events occurred in either group. Gastrointestinal symptoms were the most commonly reported adverse events, occurring in 74 percent of the placebo group and 77 percent of the ganciclovir group. Other events included neuropathy, neutropenia, anemia and mild increases in serum creatinine concentrations.
These results suggest that oral ganciclovir may significantly decrease the risk of cytomegalovirus disease in persons with advanced AIDS. Although the drug did not significantly increase overall survival, the survival-free interval for cytomegalovirus disease was significantly prolonged.
COPYRIGHT 1996 American Academy of Family Physicians
COPYRIGHT 2004 Gale Group
Contact
Home
A
Gabapentin