Ganciclovir treatment of gastrointestinal infections caused by cytomegalovirus in patients with AIDS.

Ganciclovir (DHPG) treatment of 69 AIDS patients with gastrointestinal infection due to cytomegalovirus (CMV) was studied. Sites of infection included the colon (46 patients, 67%), esophagus and stomach (15 patients, 22%), rectum (five patients, 7%), liver (two patients, 3%), and small bowel (one patient, 1.4%). Ganciclovir was given in a dose of 5 mg/kg intravenously every 12 hours for 14 days. Maintenance therapy consisted of 6 mg/kg daily. Positive clinical responses were seen in 52 (75%) of the 69 patients, stable responses in 9 (13%), and worsening in eight (11%). The virologic response was positive in 47 patients (68%), while virologic findings did not change in three patients (4%) and could not be evaluated in 19 patients (28%). Toxicity was mainly hematologic, with moderate leukopenia (1,000-1,900 leukocytes/mm3) in seven patients and severe leukopenia (less than 1,000 leukocytes/mm3) in three patients. The median survival time was 18 weeks (range, 1-68 weeks). Forty-seven patients survived for 4 weeks; of these, 22 (47%) relapsed. The median time to relapse was 9 weeks. Despite the uncontrolled nature of this study, ganciclovir is probably an effective and safe agent for the treatment of gastrointestinal CMV infections. The high probability of relapse (50%) should be considered and maintenance therapy offered to most patients.