title: A pilot study of ribavirin therapy for chronic hepatitis C.
abstract: Interferon-alpha therapy is of proven efficacy in chronic hepatitis C, but it is not universally effective and may be associated with intolerable side effects. Ribavirin is a nucleoside analog with a broad spectrum of antiviral action. We conducted an uncontrolled pilot study of ribavirin therapy in 13 patients with chronic hepatitis C. Ribavirin was given for 6 mo, in a dose that was increased, at 2-mo intervals, from 600 mg to 1,000 mg to 1,200 mg/day. Serum ALT levels gradually decreased in all 13 treated patients; the mean percentage of decrease was 67% (from 210 U/L [range = 109 to 593] to 63 U/L [range = 22 to 108 U/L]; p = 0.0006) after 6 mo of treatment. Serum aminotransferase levels fell to the normal range in four patients (31%). In the 3 to 6 mo after cessation of ribavirin therapy, serum aminotransferase activities gradually rose to near pretreatment levels in all but one patient. Therapy was associated with a significant decrease in the geometric mean titer of hepatitis C virus RNA in serum (1:1,981 vs. 1:199; p less than 0.02) although no patients lost hepatitis C virus RNA from serum during therapy. No significant improvement was seen in liver histological appearance. Ribavirin therapy resulted in mild, reversible hemolysis; no patient exhibited symptomatic anemia. These findings suggest that ribavirin has a beneficial effect in patients with chronic hepatitis C, although further studies are needed to determine how ribavirin is best used.
authors.affiliation: Liver Disease Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland 20892.
authors.forename: A M
authors.initials: AM
authors.lastname: Di Bisceglie
authors.forename: M
authors.initials: M
authors.lastname: Shindo
authors.forename: T L
authors.initials: TL
authors.lastname: Fong
authors.forename: M W
authors.initials: MW
authors.lastname: Fried
authors.forename: M G
authors.initials: MG
authors.lastname: Swain
authors.forename: N V
authors.initials: NV
authors.lastname: Bergasa
authors.forename: C A
authors.initials: CA
authors.lastname: Axiotis
authors.forename: J G
authors.initials: JG
authors.lastname: Waggoner
authors.forename: Y
authors.initials: Y
authors.lastname: Park
authors.forename: J H
authors.initials: JH
authors.lastname: Hoofnagle
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D015415:Biomarkers / Q000097:blood; D004334:Drug Administration Schedule; D005260:Female; D006526:Hepatitis C / Q000097:blood / Q000188:drug therapy* / Q000201:enzymology; D006521:Hepatitis, Chronic / Q000097:blood / Q000188:drug therapy* / Q000201:enzymology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012367:RNA, Viral / Q000097:blood; D012254:Ribavirin / Q000627:therapeutic use*
chemical_list: D015415:Biomarkers; D012367:RNA, Viral; D012254:Ribavirin; D000410:Alanine Transaminase