A randomized trial of pegylated interferon alpha-2b plus ribavirin in the retreatment of chronic hepatitis C.
OBJECTIVE
The efficacy of combination therapy with pegylated interferon (PEG IFN) alpha plus ribavirin (RBV) in the retreatment of chronic hepatitis C (CHC) in patients who previously failed combination standard IFN plus RBV or IFN monotherapy has not been well established.


METHODS
Three hundred and twenty-one CHC patients including virologic nonresponders to combination IFN plus RBV (n = 219) or IFN monotherapy (n = 47), and relapsers to combination therapy (n = 55) were randomized to receive PEG IFN alpha-2b 1.5 microg/kg per wk plus RBV 800 mg per day (Regimen A, n = 160) or PEG IFN alpha-2b 1.0 microg/kg per wk plus RBV 1,000-1,200 mg per day (Regimen B, n = 161) for 48 wks.


RESULTS
Sustained virologic response (SVR) occurred in 16% of the overall study population (Regimen A vs B, 18%vs 13%, p= 0.21), in 8% of the combination therapy nonresponders (10%vs 6%, p= 0.35), in 21% of the IFN monotherapy nonresponders (16%vs 27%, p= 0.35), and in 42% of the combination therapy relapsers (50%vs 32%, p= 0.18). In nonresponders to prior combination therapy, HCV ribonucleic acid levels <100,000 copies/mL at the end of the prior treatment course were associated with an increased SVR compared with levels >or=100,000 copies/mL (21%vs 5%, p= 0.002). In the overall study population, genotype 1 patients had lower SVR rates than others (14%vs 33%, p= 0.01), and African Americans had lower SVR than Caucasians (4%vs 18%, p= 0.01).


CONCLUSIONS
Combination therapy with PEG IFN alpha-2b plus RBV is more effective in patients who relapsed after combination standard IFN plus RBV than in nonresponders to either combination therapy or IFN monotherapy. There was no significant effect of dosing regimen.
Jacobson
Ira M
IM
Center for the Study of Hepatitis C and Division of Gastroenterology and Hepatology, Weill Medical College of Cornell University, New York, New York 10021, USA.
Gonzalez
Stevan A
SA
Ahmed
Furqaan
F
Lebovics
Edward
E
Min
Albert D
AD
Bodenheimer
Henry C
HC
Esposito
Stephen P
SP
Brown
Robert S
RS
Bräu
Norbert
N
Klion
Franklin M
FM
Tobias
Hillel
H
Bini
Edmund J
EJ
Brodsky
Neil
N
Cerulli
Maurice A
MA
Aytaman
Ayse
A
Gardner
Peter W
PW
Geders
Jane M
JM
Spivack
Julie E
JE
Rahmin
Michael G
MG
Berman
David H
DH
Ehrlich
James
J
Russo
Mark W
MW
Chait
Maxwell
M
Rovner
Deborah
D
Edlin
Brian R
BR
D001741:Black or African American; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004337:Drug Carriers; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins; D012008:Recurrence; D019233:Retreatment; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D044465:White People
D000998:Antiviral Agents; D004337:Drug Carriers; D004338:Drug Combinations; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b