Good Safety Profile and Efficacy of Leucocyte Interferon-α in Combination with Oral Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C

A Multicentre, Randomised, Controlled Study

Giuseppe Barbaro, Benvenuto Grisorio, Luigi Fruttaldo, Donato Bacca, Sergio Babudieri, Donato Torre, Ruggiero Francavilla, Giovanni Rizzo, Giancarlo Belloni, Alfio Lucchini, Mauro Annese, Filippo Matarazzo, Christina Hazra, Giorgio Barbarini

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: The differential tolerability profile of various interferon (IFN)-α preparations used in combination with ribavirin for the treatment of chronic hepatitis C needs to be elucidated. Approximately 8% of patients receiving recombinant IFNα-2b plus ribavirin discontinue treatment because of adverse events. Human leucocyte IFNα is deemed to have a better safety profile than recombinant IFNα. We therefore compared the safety profile and efficacy of ribavirin combined with leucocyte IFNα or with recombinant IFNα-2b in treatment-naive patients with chronic hepatitis C. Study design: We randomised 423 patients to either leucocyte IFNα 3MU three times weekly plus ribavirin (210 patients) or the same dose of recombinant IFNα-2b plus ribavirin (213 patients). Patients were treated for 24 weeks and followed-up for a further 48 weeks. The primary endpoint was the safety profile of the two therapies; the secondary endpoint was the rate of sustained response. Results: In patients receiving leucocyte IFNα, the total number of adverse events was lower than in the group receiving recombinant IFNα (259 vs 441 patients), and the percentage of patients discontinuing treatment because of adverse events or laboratory abnormalities was significantly reduced (4% vs 11%; p = 0.013). Sustained response was observed in 47% of patients receiving leucocyte IFNα plus ribavirin and in 44% of patients receiving IFNα-2b plus ribavirin. Conclusions: Both therapeutic regimens were effective in inducing a sustained response in naive patients. However, the safety profile of leucocyte IFNα plus ribavirin was more favourable than that observed with the administration of recombinant IFNα-2b plus ribavirin, suggesting that leucocyte IFNα may be an alternative option in patients with reduced tolerability to other IFNs.

Original languageEnglish
Pages (from-to)433-439
Number of pages7
JournalBioDrugs
Volume17
Issue number6
DOIs
Publication statusPublished - 2003

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Ribavirin
Chronic Hepatitis C
Interferon-alpha
Safety
Interferons
Therapeutics

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Immunology and Allergy
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Good Safety Profile and Efficacy of Leucocyte Interferon-α in Combination with Oral Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C : A Multicentre, Randomised, Controlled Study. / Barbaro, Giuseppe; Grisorio, Benvenuto; Fruttaldo, Luigi; Bacca, Donato; Babudieri, Sergio; Torre, Donato; Francavilla, Ruggiero; Rizzo, Giovanni; Belloni, Giancarlo; Lucchini, Alfio; Annese, Mauro; Matarazzo, Filippo; Hazra, Christina; Barbarini, Giorgio.

In: BioDrugs, Vol. 17, No. 6, 2003, p. 433-439.

Research output: Contribution to journalArticle

Barbaro, G, Grisorio, B, Fruttaldo, L, Bacca, D, Babudieri, S, Torre, D, Francavilla, R, Rizzo, G, Belloni, G, Lucchini, A, Annese, M, Matarazzo, F, Hazra, C & Barbarini, G 2003, 'Good Safety Profile and Efficacy of Leucocyte Interferon-α in Combination with Oral Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C: A Multicentre, Randomised, Controlled Study', BioDrugs, vol. 17, no. 6, pp. 433-439. https://doi.org/10.2165/00063030-200317060-00006
Barbaro, Giuseppe ; Grisorio, Benvenuto ; Fruttaldo, Luigi ; Bacca, Donato ; Babudieri, Sergio ; Torre, Donato ; Francavilla, Ruggiero ; Rizzo, Giovanni ; Belloni, Giancarlo ; Lucchini, Alfio ; Annese, Mauro ; Matarazzo, Filippo ; Hazra, Christina ; Barbarini, Giorgio. / Good Safety Profile and Efficacy of Leucocyte Interferon-α in Combination with Oral Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C : A Multicentre, Randomised, Controlled Study. In: BioDrugs. 2003 ; Vol. 17, No. 6. pp. 433-439.
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abstract = "Background: The differential tolerability profile of various interferon (IFN)-α preparations used in combination with ribavirin for the treatment of chronic hepatitis C needs to be elucidated. Approximately 8{\%} of patients receiving recombinant IFNα-2b plus ribavirin discontinue treatment because of adverse events. Human leucocyte IFNα is deemed to have a better safety profile than recombinant IFNα. We therefore compared the safety profile and efficacy of ribavirin combined with leucocyte IFNα or with recombinant IFNα-2b in treatment-naive patients with chronic hepatitis C. Study design: We randomised 423 patients to either leucocyte IFNα 3MU three times weekly plus ribavirin (210 patients) or the same dose of recombinant IFNα-2b plus ribavirin (213 patients). Patients were treated for 24 weeks and followed-up for a further 48 weeks. The primary endpoint was the safety profile of the two therapies; the secondary endpoint was the rate of sustained response. Results: In patients receiving leucocyte IFNα, the total number of adverse events was lower than in the group receiving recombinant IFNα (259 vs 441 patients), and the percentage of patients discontinuing treatment because of adverse events or laboratory abnormalities was significantly reduced (4{\%} vs 11{\%}; p = 0.013). Sustained response was observed in 47{\%} of patients receiving leucocyte IFNα plus ribavirin and in 44{\%} of patients receiving IFNα-2b plus ribavirin. Conclusions: Both therapeutic regimens were effective in inducing a sustained response in naive patients. However, the safety profile of leucocyte IFNα plus ribavirin was more favourable than that observed with the administration of recombinant IFNα-2b plus ribavirin, suggesting that leucocyte IFNα may be an alternative option in patients with reduced tolerability to other IFNs.",
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T1 - Good Safety Profile and Efficacy of Leucocyte Interferon-α in Combination with Oral Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C

T2 - A Multicentre, Randomised, Controlled Study

AU - Barbaro, Giuseppe

AU - Grisorio, Benvenuto

AU - Fruttaldo, Luigi

AU - Bacca, Donato

AU - Babudieri, Sergio

AU - Torre, Donato

AU - Francavilla, Ruggiero

AU - Rizzo, Giovanni

AU - Belloni, Giancarlo

AU - Lucchini, Alfio

AU - Annese, Mauro

AU - Matarazzo, Filippo

AU - Hazra, Christina

AU - Barbarini, Giorgio

PY - 2003

Y1 - 2003

N2 - Background: The differential tolerability profile of various interferon (IFN)-α preparations used in combination with ribavirin for the treatment of chronic hepatitis C needs to be elucidated. Approximately 8% of patients receiving recombinant IFNα-2b plus ribavirin discontinue treatment because of adverse events. Human leucocyte IFNα is deemed to have a better safety profile than recombinant IFNα. We therefore compared the safety profile and efficacy of ribavirin combined with leucocyte IFNα or with recombinant IFNα-2b in treatment-naive patients with chronic hepatitis C. Study design: We randomised 423 patients to either leucocyte IFNα 3MU three times weekly plus ribavirin (210 patients) or the same dose of recombinant IFNα-2b plus ribavirin (213 patients). Patients were treated for 24 weeks and followed-up for a further 48 weeks. The primary endpoint was the safety profile of the two therapies; the secondary endpoint was the rate of sustained response. Results: In patients receiving leucocyte IFNα, the total number of adverse events was lower than in the group receiving recombinant IFNα (259 vs 441 patients), and the percentage of patients discontinuing treatment because of adverse events or laboratory abnormalities was significantly reduced (4% vs 11%; p = 0.013). Sustained response was observed in 47% of patients receiving leucocyte IFNα plus ribavirin and in 44% of patients receiving IFNα-2b plus ribavirin. Conclusions: Both therapeutic regimens were effective in inducing a sustained response in naive patients. However, the safety profile of leucocyte IFNα plus ribavirin was more favourable than that observed with the administration of recombinant IFNα-2b plus ribavirin, suggesting that leucocyte IFNα may be an alternative option in patients with reduced tolerability to other IFNs.

AB - Background: The differential tolerability profile of various interferon (IFN)-α preparations used in combination with ribavirin for the treatment of chronic hepatitis C needs to be elucidated. Approximately 8% of patients receiving recombinant IFNα-2b plus ribavirin discontinue treatment because of adverse events. Human leucocyte IFNα is deemed to have a better safety profile than recombinant IFNα. We therefore compared the safety profile and efficacy of ribavirin combined with leucocyte IFNα or with recombinant IFNα-2b in treatment-naive patients with chronic hepatitis C. Study design: We randomised 423 patients to either leucocyte IFNα 3MU three times weekly plus ribavirin (210 patients) or the same dose of recombinant IFNα-2b plus ribavirin (213 patients). Patients were treated for 24 weeks and followed-up for a further 48 weeks. The primary endpoint was the safety profile of the two therapies; the secondary endpoint was the rate of sustained response. Results: In patients receiving leucocyte IFNα, the total number of adverse events was lower than in the group receiving recombinant IFNα (259 vs 441 patients), and the percentage of patients discontinuing treatment because of adverse events or laboratory abnormalities was significantly reduced (4% vs 11%; p = 0.013). Sustained response was observed in 47% of patients receiving leucocyte IFNα plus ribavirin and in 44% of patients receiving IFNα-2b plus ribavirin. Conclusions: Both therapeutic regimens were effective in inducing a sustained response in naive patients. However, the safety profile of leucocyte IFNα plus ribavirin was more favourable than that observed with the administration of recombinant IFNα-2b plus ribavirin, suggesting that leucocyte IFNα may be an alternative option in patients with reduced tolerability to other IFNs.

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