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GANGCYCLOVIR SHOWS PROMISE IN INCREASING SURVIVAL OF AIDS PATIENTS WITH CMV INFECTIONS; EFLORNITHINE, TRIMETREXATE EFFICACY SEEN IN PNEUMONIA PATIENTS

Executive Summary

Gangcyclovir (DHPG) treatment and maintenance therapy for cytomegalovirus infection "may be associated with an increased incidence of survival in AIDS patients," Douglas Dieterich, New York University Medical Center, reported at the third International AIDS Conference held in Washington, D.C. June 1-5. Dieterich presented data on the first 122 patients from a compassionate use study, in which a total of 163 patients were enrolled from January 1985 through June 1987. Patients were administered 5 mg/kg gangcyclovir I.V. b.i.d. for 14 days and if a relapse occurred were retreated with 6 mg/kg daily. Dieterich stated that "72% of the patients improved, 6.5% stabilized, 18% worsened, and 3.2% were not evaluable." He noted that the relapse rate was about 55% and mean time to relapse was nine weeks. With regard to survival, Dieterich reported that median survival was 19 weeks. Noting that 62 patients received maintenance therapy, he stated that "the probability of survival on maintenance was 38 weeks, without maintenance was 18 weeks." In addition, he observed that "the probability of survival from the date of their first [episode of] pneumocystis [pneumonia] for patients who received maintenance therapy was 45 weeks, and for the patients who did not receive maintenance it was 35 weeks." Dieterich noted that Syntex devised the study protocol. Results of studies on gangcyclovir and five other agents for treatment of opportunistic infections associated with AIDS were presented at one conference session. Two agents, Warner-Lambert's orphan drug trimetrexate and Merrell-Dow's orphan eflornithine, were reported to have shown efficacy in treatment of pneumocystis carinii pneumonia. In a study of trimetrexate, 49 patients were in one of three drug treatment groups: trimetrexate with leucovorin plus sulfadiazine as initial therapy for patients without a previous history of sulfadiazine intolerance; trimetrexate with leucovorin alone as initial therapy for patients with a history of sulfadiazine and pentamidine intolerance; or trimetrexate with leucovorin alone as salvage therapy for patients failing to respond to at least seven days of both trimethoprim-sulfamethoxazole and pentamidine. Trimetrexate 30 mg/m I.V. was administered every day for 21 days; leucovorin dose was 20 mg/m I.V. Carmen Allegra, National Institutes of Health, reported that the number of patients surviving the episode of pneumonia for group I was 13 out of 17 patients (77%), for group II was 14 out of 16 (88%) and for group III was 11 out of 16 (69%). He concluded that further studies are needed to "determine the optimal dosing schedule for trimetrexate and to determine the relative merits of this drug compared to currently available therapy." In response to a question, Allegra said trials using the combination of trimetrexate and AZT are under consideration. B. D. McLees, Merrell Dow Research Institute, reported the results of a compassionate use clinical trial of eflornithine in AIDS patients with pneumocystis carinii pneumonia who were resistant to conventional therapy with trimethoprim-sulfamethoxazole and/or pentamidine. Patients received an initial dose of 100 mg/kg I.V. every six hours for 14 days and then 75 mg/kg orally every six hours for four to six weeks. A total of 345 patients entered the trial but only 160 patients, those receiving 14 or more days of therapy, were evaluated. The primary measure of efficacy was survival to hospital discharge. McLees reported: "Overall, 125 patients who really had little or no hope for survival, survived to be discharged from the hospital following eflornithine treatment. The overall survival, and this includes the 44% of patients who were on mechanical ventilation at study entry" and the 100 patients "who received less than four days of eflornithine treatment, was 36%." He added that this "really represents a worse case, bottom value for the efficacy of the drug." McLees stated that "when we look at patients who completed the recommended 14 or more days of treatment, the survival was 23% for those in frank respiratory failure requiring mechanical ventialtion at study entry and it was 78% for those patients able to breathe spontaneously at study entry." G. H. Friedland, Montefiore Medical Center, presented the findings of a randomized, double-blind, placebo-controlled trial of recombinant alpha interferon in 67 AIDS patients. He reported that "no statistical differences in efficacy or toxicity were observed" between the placebo group and the two treatment groups (3 million units and 36 million units of alpha interferon). Specifically, he said that although the number of patients experiencing opportunistic infections was greater in the placebo group, it was not significant. He said there was also not a significant difference between the three groups in T4 cell counts.
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