title: A preliminary experience with GM-CSF plus interferon in patients with HBV and HCV resistant to interferon therapy.
abstract: An open label trial of GM-CSF plus high-dose interferon (IFN) alpha 2b was performed in eight patients with chronic hepatitis B infection and 16 patients with chronic hepatitis C, who either failed to clear virus with 6 months of daily high-dose IFN (5 MU daily) therapy (n = 22) or were considered untreatable because of advanced disease and leukopenia (n = 2). The dose of GM-CSF used was 500 micrograms subcutaneously twice weekly. The dose of IFN used was 5 MU daily. Both agents were administered for 4 months. Five of the eight hepatitis B patients and five of the 16 hepatitis C virus patients responded to combined therapy having previously failed IFN therapy alone. The hepatitis B virus responders 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 viral clearance than IFN alone.
authors.affiliation: West Penn Hospital, Pittsburgh, PA, USA.
authors.forename: D H
authors.initials: DH
authors.lastname: Van Thiel
authors.forename: L
authors.initials: L
authors.lastname: Friedlander
authors.forename: R J
authors.initials: RJ
authors.lastname: Kania
authors.forename: P J
authors.initials: PJ
authors.lastname: Molloy
authors.forename: T
authors.initials: T
authors.lastname: Hassanein
authors.forename: H
authors.initials: H
authors.lastname: Faruki
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006509:Hepatitis B / Q000097:blood / Q000188:drug therapy*; D006526:Hepatitis C / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor