Daily interferon regimen for chronic hepatitis C. A prospective randomised study

Raffaele Bruno, Maurizia Debiaggi, Paolo Sacchi, Elena Maffezzini, Francesca Zara, Enrico Brunetti, Carlo Filice, Savino F A Patruno, Gaetano Filice

Research output: Contribution to journalArticle

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Abstract

Objective: To compare the safety and efficacy of two regimens of lymphoblastoid interferon, 3 MU daily for 12 months vs 6 MU three times weekly for 12 months, for the treatment of patients with chronic hepatitis C. Design: This was a prospective, randomised, nonblind study. Setting: The study was conducted in outpatients attending the University Hospital in Pavia, Italy, between 1997 and 1998. Patients: 100 treatment-naive outpatients with chronic hepatitis C genotype 1b participated in the study. Main Outcome Measures: We measured serum hepatitis C virus (HCV) RNA levels, serum alanine aminotransferase (ALT), histological activity index score and fibrosis stage. Patients were classified as follows: primary responders (PR) when ALT normalised and HCV-RNA became negative during treatment; nonresponders (NR) if ALT remained elevated and HCV-RNA remained positive during treatment; sustained responders (SR) when HCV-RNA became persistently negative and ALT became normalised during treatment and for at least 6 months after treatment; relapsers (R) were PR whose ALT returned to abnormal values and HCV-RNA became positive again after the end of treatment. Results: 50 patients received 3 MU daily, of whom 42 (84%) were PR and eight (16%) were NR. Of the 42 PR, 23 (54.7%) were SR and 19 (45.3%) were R. 50 patients received 6 MU three times weekly, of whom 21 (42%) were PR and 29 (58%) were NR. Of the 21 PR, five (23.8%) were SR and 16 (76.2%) were R. Adverse effects were comparable in the two groups and were never serious enough to require withdrawal of therapy. Conclusion: These findings support the choice of a 3 MU daily regimen of lymphoblastoid interferon for the treatment of patients with chronic HCV infection and provide corroborative evidence in support of molecular virological data suggesting a relatively rapid viral turnover in this clinical setting.

Original languageEnglish
Pages (from-to)11-16
Number of pages6
JournalClinical Drug Investigation
Volume18
Issue number1
DOIs
Publication statusPublished - 1999

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Chronic Hepatitis C
Interferons
Prospective Studies
Hepacivirus
Alanine Transaminase
RNA
Therapeutics
Interferon-alpha
Outpatients
Virus Diseases
Serum
Italy
Fibrosis
Genotype
Outcome Assessment (Health Care)
Safety

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology

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Daily interferon regimen for chronic hepatitis C. A prospective randomised study. / Bruno, Raffaele; Debiaggi, Maurizia; Sacchi, Paolo; Maffezzini, Elena; Zara, Francesca; Brunetti, Enrico; Filice, Carlo; Patruno, Savino F A; Filice, Gaetano.

In: Clinical Drug Investigation, Vol. 18, No. 1, 1999, p. 11-16.

Research output: Contribution to journalArticle

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abstract = "Objective: To compare the safety and efficacy of two regimens of lymphoblastoid interferon, 3 MU daily for 12 months vs 6 MU three times weekly for 12 months, for the treatment of patients with chronic hepatitis C. Design: This was a prospective, randomised, nonblind study. Setting: The study was conducted in outpatients attending the University Hospital in Pavia, Italy, between 1997 and 1998. Patients: 100 treatment-naive outpatients with chronic hepatitis C genotype 1b participated in the study. Main Outcome Measures: We measured serum hepatitis C virus (HCV) RNA levels, serum alanine aminotransferase (ALT), histological activity index score and fibrosis stage. Patients were classified as follows: primary responders (PR) when ALT normalised and HCV-RNA became negative during treatment; nonresponders (NR) if ALT remained elevated and HCV-RNA remained positive during treatment; sustained responders (SR) when HCV-RNA became persistently negative and ALT became normalised during treatment and for at least 6 months after treatment; relapsers (R) were PR whose ALT returned to abnormal values and HCV-RNA became positive again after the end of treatment. Results: 50 patients received 3 MU daily, of whom 42 (84{\%}) were PR and eight (16{\%}) were NR. Of the 42 PR, 23 (54.7{\%}) were SR and 19 (45.3{\%}) were R. 50 patients received 6 MU three times weekly, of whom 21 (42{\%}) were PR and 29 (58{\%}) were NR. Of the 21 PR, five (23.8{\%}) were SR and 16 (76.2{\%}) were R. Adverse effects were comparable in the two groups and were never serious enough to require withdrawal of therapy. Conclusion: These findings support the choice of a 3 MU daily regimen of lymphoblastoid interferon for the treatment of patients with chronic HCV infection and provide corroborative evidence in support of molecular virological data suggesting a relatively rapid viral turnover in this clinical setting.",
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AU - Sacchi, Paolo

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AB - Objective: To compare the safety and efficacy of two regimens of lymphoblastoid interferon, 3 MU daily for 12 months vs 6 MU three times weekly for 12 months, for the treatment of patients with chronic hepatitis C. Design: This was a prospective, randomised, nonblind study. Setting: The study was conducted in outpatients attending the University Hospital in Pavia, Italy, between 1997 and 1998. Patients: 100 treatment-naive outpatients with chronic hepatitis C genotype 1b participated in the study. Main Outcome Measures: We measured serum hepatitis C virus (HCV) RNA levels, serum alanine aminotransferase (ALT), histological activity index score and fibrosis stage. Patients were classified as follows: primary responders (PR) when ALT normalised and HCV-RNA became negative during treatment; nonresponders (NR) if ALT remained elevated and HCV-RNA remained positive during treatment; sustained responders (SR) when HCV-RNA became persistently negative and ALT became normalised during treatment and for at least 6 months after treatment; relapsers (R) were PR whose ALT returned to abnormal values and HCV-RNA became positive again after the end of treatment. Results: 50 patients received 3 MU daily, of whom 42 (84%) were PR and eight (16%) were NR. Of the 42 PR, 23 (54.7%) were SR and 19 (45.3%) were R. 50 patients received 6 MU three times weekly, of whom 21 (42%) were PR and 29 (58%) were NR. Of the 21 PR, five (23.8%) were SR and 16 (76.2%) were R. Adverse effects were comparable in the two groups and were never serious enough to require withdrawal of therapy. Conclusion: These findings support the choice of a 3 MU daily regimen of lymphoblastoid interferon for the treatment of patients with chronic HCV infection and provide corroborative evidence in support of molecular virological data suggesting a relatively rapid viral turnover in this clinical setting.

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