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. Methods: This prospective, international, multicenter, open-label study evaluated efficacy and safety of peginterferon alfa-2b (1.5 μg/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. 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 (≤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. 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.
| Original language | English |
|---|---|
| Journal | Gastroenterology |
| Volume | 136 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - May 2009 |
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ASJC Scopus subject areas
- Gastroenterology
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Peginterferon alfa-2b and Ribavirin : Effective in Patients With Hepatitis C Who Failed Interferon alfa/Ribavirin Therapy. / Poynard, Thierry; Colombo, Massimo; Bruix, Jordi; Schiff, Eugene; Terg, Ruben; Flamm, Steven; Moreno-Otero, Ricardo; Carrilho, Flair; Schmidt, Warren; Berg, Thomas; McGarrity, Thomas; Heathcote, E. Jenny; Gonçales, Fernando; Diago, Moises; Craxi, Antonio; Silva, Marcelo; Bedossa, Pierre; Mukhopadhyay, Pabak; Griffel, Louis; Burroughs, Margaret; Brass, Clifford; Albrecht, Janice.
In: Gastroenterology, Vol. 136, No. 5, 05.2009.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Peginterferon alfa-2b and Ribavirin
T2 - Effective in Patients With Hepatitis C Who Failed Interferon alfa/Ribavirin Therapy
AU - Poynard, Thierry
AU - Colombo, Massimo
AU - Bruix, Jordi
AU - Schiff, Eugene
AU - Terg, Ruben
AU - Flamm, Steven
AU - Moreno-Otero, Ricardo
AU - Carrilho, Flair
AU - Schmidt, Warren
AU - Berg, Thomas
AU - McGarrity, Thomas
AU - Heathcote, E. Jenny
AU - Gonçales, Fernando
AU - Diago, Moises
AU - Craxi, Antonio
AU - Silva, Marcelo
AU - Bedossa, Pierre
AU - Mukhopadhyay, Pabak
AU - Griffel, Louis
AU - Burroughs, Margaret
AU - Brass, Clifford
AU - Albrecht, Janice
PY - 2009/5
Y1 - 2009/5
N2 - 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. Methods: This prospective, international, multicenter, open-label study evaluated efficacy and safety of peginterferon alfa-2b (1.5 μg/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. 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 (≤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. 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.
AB - 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. Methods: This prospective, international, multicenter, open-label study evaluated efficacy and safety of peginterferon alfa-2b (1.5 μg/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. 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 (≤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. 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.
UR - http://www.scopus.com/inward/record.url?scp=67349172961&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=67349172961&partnerID=8YFLogxK
U2 - 10.1053/j.gastro.2009.01.039
DO - 10.1053/j.gastro.2009.01.039
M3 - Article
C2 - 19208349
AN - SCOPUS:67349172961
VL - 136
JO - Gastroenterology
JF - Gastroenterology
SN - 0016-5085
IS - 5
ER -