Peginterferon alfa-2b and Ribavirin: Effective in Patients With Hepatitis C Who Failed Interferon alfa/Ribavirin Therapy

Thierry Poynard, Massimo Colombo, Jordi Bruix, Eugene Schiff, Ruben Terg, Steven Flamm, Ricardo Moreno-Otero, Flair Carrilho, Warren Schmidt, Thomas Berg, Thomas McGarrity, E. Jenny Heathcote, Fernando Gonçales, Moises Diago, Antonio Craxi, Marcelo Silva, Pierre Bedossa, Pabak Mukhopadhyay, Louis Griffel, Margaret BurroughsClifford Brass, Janice Albrecht

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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 languageEnglish
JournalGastroenterology
Volume136
Issue number5
DOIs
Publication statusPublished - May 2009

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Ribavirin
Hepatitis C
Interferon-alpha
Hepacivirus
RNA
Fibrosis
Therapeutics
Odds Ratio
Genotype
peginterferon alfa-2b
Safety
Weights and Measures
Chronic Hepatitis C
Viral Load
Maintenance
Research Personnel
Recurrence
Sustained Virologic Response

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 journalArticle

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 2009, 'Peginterferon alfa-2b and Ribavirin: Effective in Patients With Hepatitis C Who Failed Interferon alfa/Ribavirin Therapy', Gastroenterology, vol. 136, no. 5. https://doi.org/10.1053/j.gastro.2009.01.039
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. / Peginterferon alfa-2b and Ribavirin : Effective in Patients With Hepatitis C Who Failed Interferon alfa/Ribavirin Therapy. In: Gastroenterology. 2009 ; Vol. 136, No. 5.
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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.

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