SciClone Pharmaceuticals Inc. reported interim positive results froma Phase III trial of Zadaxin and alpha interferon in hepatitis Cpatients at the annual meeting of the American Association for theStudy of Liver Diseases in Chicago.
The combination of Zadaxin and alpha interferon demonstratedsignificantly higher efficacy than single-agent alpha interferon, theonly FDA-approved therapy for chronic hepatitis C, said MarkCulhane, chief financial officer at SciClone, of San Mateo, Calif.
The randomized, double-blind and placebo-controlled trial included103 patients.
Biochemical response, Culhane said, was observed in 41.9 percent ofpatients treated with the combination therapy, 16.6 percent amongpatients treated with alpha interferon only and 2.7 percent among thepatients who received placebo.
Among patients with genotype 1a or 1b, a complete response wasobserved in 31 percent of the patients treated with combinationtherapy, Culhane said, compared with 12 percent among patientstreated with single-agent interferon.
Over 50 percent of the patients were genotype 1a or 1b, which, in thetreatment of hepatitis C, is the most resistant to current forms oftreatment, Culhane said.
"Over 70 percent of hepatitis C is genotype 1a or 1b," said Culhane."There were no side effects from the combination therapy. We arevery encouraged with the outcome."
Among patients with other genotypes, the researchers observedcomplete response in 50 percent of patients treated with combinationtherapy, compared with 25 percent among patients treated withsingle-agent interferon. _ Frances Bishopp
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