Therapy of chronic hepatitis B with a 6-month course of ribavirin.
Ribavirin is a nucleoside analogue with broad spectrum antiviral activity that has been shown to inhibit viral replication in the woodchuck model of hepatitis B virus infection. We studied the effect of ribavirin on viral replication in 18 patients with chronic hepatitis B who were positive for hepatitis B e antigen. Patients were randomized to receive a 24-week course of oral ribavirin at a dose of either 800, 1000, or 1200 mg/kg per day. All patients completed 24 weeks of treatment and an additional 24 weeks of follow up without significant side effects except for mild, reversible hemolytic anemia. Response to ribavirin was similar among all three dosage groups (p > 0.5); hence the data were pooled and analyzed together. Mean hepatitis B virus DNA levels decreased from 162.7 (95% confidence interval, 106 to 219) pg/ml before treatment to its lowest level of 114.3 (95% confidence interval, 53 to 175) pg/ml at week 20 (p < 0.05). Two patients became negative for HBV DNA and lost hepatitis B e antigen. Mean serum alanine aminotransferase activity decreased markedly from 131.1 (95% confidence interval, 84 to 178) U/l before treatment to 62.4 (95% confidence interval, 48 to 77) U/l at the end of 24 weeks of ribavirin (p < 0.05) and became normal in four patients (22%). Aminotransferase levels returned to baseline within 4 weeks once ribavirin was discontinued, while HBV DNA concentrations remained below baseline even at the end of 24 weeks of follow up.(ABSTRACT TRUNCATED AT 250 WORDS)
Fried
M W
MW
National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland 20892.
Fong
T L
TL
Swain
M G
MG
Park
Y
Y
Beames
M P
MP
Banks
S M
SM
Hoofnagle
J H
JH
Di Bisceglie
A M
AM
D000284:Administration, Oral; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D002908:Chronic Disease; D015331:Cohort Studies; D004279:DNA, Viral / Q000032:analysis / Q000235:genetics; D004305:Dose-Response Relationship, Drug; D005260:Female; D006509:Hepatitis B / Q000188:drug therapy* / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006515:Hepatitis B virus / Q000235:genetics / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009705:Nucleosides / Q000494:pharmacology / Q000627:therapeutic use; D012254:Ribavirin / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D013997:Time Factors; D014779:Virus Replication / Q000187:drug effects / Q000502:physiology
D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D009705:Nucleosides; D012254:Ribavirin; D000410:Alanine Transaminase