TREATMENT OF CYTOMEGALOVIRUS ESOPHAGITIS IN PATIENTS WITH ACQUIRED-IMMUNE-DEFICIENCY-SYNDROME - A RANDOMIZED CONTROLLED-STUDY OF FOSCARNET VERSUS GANCICLOVIR

Objective: Although several uncontrolled studies have shown that the r esponse rate to ganciclovir and foscarnet for all forms of cytomegalov irus (CMV) infection in immunocompromised patients is almost similar, to date, no controlled clinical trial has been specifically designed t o compare these two agents in the treatment of CMV esophagitis, The ai m of this study was, therefore, to compare the efficacy and safety of these two drugs in the induction therapy of CMV esophagitis in patient s with acquired immunodeficiency syndrome (AIDS), Methods: Thirty-nine of 211 (18%) consecutive AIDS patients undergoing endoscopy for esoph ageal 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 rand omized 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 t reated with ganciclovir, Clinical and laboratory evaluation was perfor med weekly, and endoscopy was repeated at the end of therapy. The two treatment groups were well balanced as to the following characteristic s 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 endoscop ic improvement (complete disappearance of macroscopic lesions or signi ficant reduction of the endoscopic score) was observed in eight of 11 (73 %) of foscarnet and seven of 10 (70%) of ganciclovir-treated patie nts, and inclusion bodies disappeared from follow-up biopsies in 55% a nd 50% of patients, respectively. The symptomatic response was also si milar for both treatments: 82% of patients who received foscarnet and 80% of those treated with ganciclovir had a complete or at least a goo d clinical response. Frequency of adverse events was comparable with b oth 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-re lated CMV esophagitis, Consequently, the choice of the anti-CMV agent should be tailored to the individual patient according to the differen t toxicity profiles of the two drugs. (C) 1998 by Am. Coll. of Gastroe nterology.