Treatment of cytomegalovirus esophagitis in patients with acquired immune deficiency syndrome: a randomized controlled study of foscarnet versus ganciclovir. The Italian Cytomegalovirus Study Group.

OBJECTIVE

Although several uncontrolled studies have shown that the response rate to ganciclovir and foscarnet for all forms of cytomegalovirus (CMV) infection in immunocompromised patients is almost similar, to date, no controlled clinical trial has been specifically designed to compare these two agents in the treatment of CMV esophagitis. The aim of this study was, therefore, to compare the efficacy and safety of these two drugs in the induction therapy of CMV esophagitis in patients with acquired immunodeficiency syndrome (AIDS).

METHODS

Thirty-nine of 211 (18%) consecutive AIDS patients undergoing endoscopy for esophageal symptoms had macroscopic esophagitis that proved to be sustained by CMV based on the documentation of typical intranuclear inclusions at histology; 23 were considered eligible for this study and were randomized to receive foscarnet 90 mg/kg b.i.d. or ganciclovir 5 mg/kg b.i.d. for 21 days. Twelve patients received foscarnet, whereas 11 were treated with ganciclovir. Clinical and laboratory evaluation was performed weekly, and endoscopy was repeated at the end of therapy. The two treatment groups were well balanced as to the following characteristics at entry: age, sex, absolute number of CD4 cells, duration of AIDS, Karnofsky score, frequency of concomitant Candida esophagitis (grade I or II), and severity of esophageal symptoms.

RESULTS

Marked endoscopic improvement (complete disappearance of macroscopic lesions or significant reduction of the endoscopic score) was observed in eight of 11 (73%) of foscarnet and seven of 10 (70%) of ganciclovir-treated patients, and inclusion bodies disappeared from follow-up biopsies in 55% and 50% of patients, respectively. The symptomatic response was also similar for both treatments: 82% of patients who received foscarnet and 80% of those treated with ganciclovir had a complete or at least a good clinical response. Frequency of adverse events was comparable with both drugs: only one patient in each group suspended treatment because of severe side effects.

CONCLUSIONS

Foscarnet and ganciclovir appear to be similarly effective and safe in the induction therapy of AIDS-related CMV esophagitis. Consequently, the choice of the anti-CMV agent should be tailored to the individual patient according to the different toxicity profiles of the two drugs.