Peg-interferon alpha-2a versus Peg-interferon alpha-2b in nonresponders with HCV active chronic hepatitis: a pilot study.
BACKGROUND
The efficacy and tolerability of Peg-Interferon alpha-2a (Peg-IFNalpha-2a) versus Peg-Interferon alpha-2b (Peg-IFNalpha-2b) were compared in a patient cohort with hepatitis C virus (HCV)-related active chronic hepatitis, unresponsive to previous antiviral treatment with standard IFN (6 MU three times/week) plus ribavirin (10.6 mg/kg/day) for a period of at least 3 months.


METHODS
A total of 143 patients were enrolled and randomized into two treatment groups (A-B). Group A (71 patients) received one vial of Peg-IFNalpha-2a weekly (180 microg) subcutaneously whereas Group B (72 patients) received 1.5 microg/kg of Peg-IFNalpha-2b weekly subcutaneously. Interferon was combined with ribavirin (15 mg/kg/day) in both groups and all patients who demonstrated nondetectable HCV-RNA or a >or=2(log) reduction in viral load at week 12, were treated for 48 weeks, with a 24-week follow up.


RESULTS
Group A (10/71) and Group B (8/72) patients discontinued treatment due to severe side effects. At the end of therapy, HCV-RNA was undetectable in 17/71 (23.9%) Group A and in 19/72 (26.4%) of Group B patients. When terminating follow up, a sustained virological response was observed in 14/71 in Group A (19.7%) and 13/72 in Group B (18.0%).


CONCLUSIONS
Within the limits of the relatively small sample size, Peg-IFNalpha-2a and Peg-IFNalpha-2b demonstrated nonstatistically significant differences in effectiveness in patients nonresponsive to previous antiviral treatment.
Scotto
Gaetano
G
Clinic of Infectious Diseases, University of Foggia, Foggia, Italy. g.scotto@medicina.unifg.it
Fazio
Vincenzina
V
Fornabaio
Chiara
C
Tartaglia
Alessandra
A
Di Tullio
Rocco
R
Saracino
Annalisa
A
Angarano
Gioacchino
G
D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects / Q000276:immunology; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use* / Q000633:toxicity; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use*
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a