A PRELIMINARY EXPERIENCE WITH GM-CSF PLUS INTERFERON IN PATIENTS WITHHBV AND HCV RESISTANT TO INTERFERON THERAPY

An open label trial of GM-CSF plus high-dose interferon (IFN) alpha 2b was performed in eight patients with chronic hepatitis B infection an d 16 patients with chronic hepatitis C, who either failed to clear vir us with 6 months of daily high-dose IFN (5 MU daily) therapy (n = 22) or were considered untreatable because of advanced disease and leukope nia (n = 2). The dose of GM-CSF used was 500 mu g subcutaneously twice weekly, The dose of IFN used was 5 MU daily, Both agents were adminis tered for 4 months. Five of the eight hepatitis B patients and five of the 16 hepatitis C virus patients responded to combined therapy havin g previously failed IFN therapy alone, The hepatitis B virus responder s had low entry ALT, AST, and gamma GPT levels as compared to the non- responders. No such differences for responders and non-responders were seen with the hepatitis C virus patients, These data suggest that the combination of GM-CSF and IFN may be more effective at achieving vira l clearance than IFN alone.