Back to Search Start Over

Peginterferon alfa-2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa/ribavirin therapy.

Authors :
Poynard T
Colombo M
Bruix J
Schiff E
Terg R
Flamm S
Moreno-Otero R
Carrilho F
Schmidt W
Berg T
McGarrity T
Heathcote EJ
Gonçales F
Diago M
Craxi A
Silva M
Bedossa P
Mukhopadhyay P
Griffel L
Burroughs M
Brass C
Albrecht J
Source :
Gastroenterology [Gastroenterology] 2009 May; Vol. 136 (5), pp. 1618-28.e2. Date of Electronic Publication: 2009 Jan 22.
Publication Year :
2009

Abstract

Background & Aims: Treatment with peginterferon alfa and ribavirin produces a sustained virologic response (SVR) in approximately 60% of hepatitis C virus (HCV)-infected patients. Alternate options are needed for patients who relapse or do not respond to therapy.<br />Methods: This prospective, international, multicenter, open-label study evaluated efficacy and safety of peginterferon alfa-2b (1.5 microg/kg/wk) plus weight-based ribavirin (800-1400 mg/day) in 2333 chronic HCV-infected patients with significant fibrosis/cirrhosis whose previous interferon alfa/ribavirin therapy failed. Patients with undetectable HCV-RNA at treatment week (TW) 12 received 48 weeks of therapy; patients with detectable HCV-RNA at TW12 could enter maintenance studies at TW18; 188 patients with low/detectable HCV-RNA at TW12 continued therapy at the investigator's request.<br />Results: Overall, 22% of the patients attained SVR (56% with undetectable HCV-RNA and 12% with low/detectable HCV-RNA at TW12). SVR was better in relapsers (38%) than nonresponders (14%), regardless of previous treatment, and in patients previously treated with interferon-alfa/ribavirin (25%) than peginterferon alfa-ribavirin (17%). Predictors of response in patients with undetectable HCV-RNA at TW12 were genotype (2/3 vs 1, respectively; odds ratio [OR] 2.4; P < .0001), fibrosis score (F2 vs F4; OR, 2.2; F3 vs F4; OR, 1.7; P < .0001), and baseline viral load (< or =600,000 vs >600,000 IU/mL; OR, 1.4; P = .0223). These factors plus previous treatment and response were overall predictors of SVR. Safety was similar among fibrosis groups.<br />Conclusions: Peginterferon alfa-2b plus weight-based ribavirin is effective and safe in patients who failed interferon alfa/ribavirin therapy. Genotype, baseline viral load, and fibrosis stage were predictors of response.

Details

Language :
English
ISSN :
1528-0012
Volume :
136
Issue :
5
Database :
MEDLINE
Journal :
Gastroenterology
Publication Type :
Academic Journal
Accession number :
19208349
Full Text :
https://doi.org/10.1053/j.gastro.2009.01.039