Treatment of chronic hepatitis C with interferon alfa-n3: a multicenter, randomized, open-label trial.
We studied the antiviral effectiveness and safety of interferon alfa-n3, a natural alpha interferon which contains multiple interferon species, in the treatment of previously untreated patients with chronic hepatitis C. Seventy-seven patients were randomized to receive either 1.0, 2.5, 5.0, or 10.0 million units (MU) of interferon alfa-n3 three times a week for 24 weeks and were then followed for an additional 24 weeks. At the end of therapy, 67% of patients in the 10 MU group normalized serum alanine transaminase (ALT) levels and 59% had no hepatitis C virus (HCV) RNA detected by polymerase chain reaction. At the end of the follow-up period, 44% of patients in the 10 MU group maintained normal ALT, and 24% had nondetectable HCV RNA. Lower doses were much less effective. Interferon alfa-n3 was well tolerated and no patient developed neutralizing anti-interferon antibodies during or after the treatment period. Interferon alfa-n3 appears to be effective against hepatitis C virus and deserves further study in larger randomized controlled trials.
Simon
D M
DM
Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.
Gordon
S C
SC
Kaplan
M M
MM
Koff
R S
RS
Regenstein
F
F
Everson
G
G
Lee
Y M
YM
Weiner
F
F
Silverman
A
A
Plasse
T
T
Fedorczyk
D
D
Liao
M J
MJ
D000328:Adult; D000368:Aged; D000906:Antibodies / Q000097:blood; D000998:Antiviral Agents / Q000276:immunology / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D015415:Biomarkers / Q000097:blood; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology; D006526:Hepatitis C / Q000201:enzymology / Q000276:immunology / Q000628:therapy*; D006521:Hepatitis, Chronic / Q000201:enzymology / Q000276:immunology / Q000628:therapy*; D006801:Humans; D016898:Interferon-alpha / Q000276:immunology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012333:RNA, Messenger / Q000097:blood
D000906:Antibodies; D000998:Antiviral Agents; D015415:Biomarkers; D016898:Interferon-alpha; D012333:RNA, Messenger; D001219:Aspartate Aminotransferases