Iron reduction and sustained response to interferon-α therapy in patients with chronic hepatitis C: Results of an Italian multicenter randomized study

Silvia Fargion, Anna Ludovica Fracanzani, Angelo Rossini, Mauro Borzio, Oliviero Riggio, Giovanni Belloni, Franco Bissoli, Roberto Ceriani, Marco Ballarè, Marco Massari, Caterina Trischitta, Pierluigi Fiore, Anna Orlandi, Lorenzo Morini, Michela Mattioli, Silvia Oldani, Bruno Cesana, Gemino Fiorelli

Research output: Contribution to journalArticle

Abstract

OBJECTIVES: It has been suggested that iron depletion improves the response to interferon in patients with chronic hepatitis C. We aimed to evaluate whether iron reduction by phlebotomy before interferon improves the rate of virological sustained response in previously untreated noncirrhotic patients. METHODS: One hundred fourteen hepatitis C virus (HCV) RNA positive patients with hepatic iron concentrations of ≥700 μg/g dry wt (men) and ≥500 μg/g dry wt (women), stratified according to HCV genotype and γ-glutamyltransferase values, were randomly allocated to interferon alone (6 MU three times a week) (group A) or to phlebotomy until iron depletion followed by interferon (6 MU three times a week) (group B). After 4 months dosage was reduced to 3 MU three times a week for another 8 months. RESULTS: Virological sustained response was observed in 25 patients (22%), nine (15.8%, 95% CI = 7.5-27.9) of group A and 16 (28.1%, 95% CI = 17.0-41.6) of group B. At univariate analysis the variables associated with the response were HCV genotypes 2-3, normal γ-glutamyltransferase, higher levels of baseline ALT, normal ALT values, and negativity for HCV-RNA at the 3rd month of therapy. At multivariate analysis, genotype and ALT levels at enrollment maintained their association with the response. A trend toward a better response to interferon was observed in patients who received phlebotomy (odds ratio = 2.32, 95% CI = 0.96-6.24, p = 0.082). Patients with hepatic iron concentration of ≤1100 μg/g dry wt had a trend toward a higher rate of virological sustained response (p = 0.059) when submitted to treatment B. CONCLUSION: Iron removal by phlebotomy is able to improve the rate of response to interferon, especially in patients with lower hepatic iron deposits; it could be useful as adjuvant therapy to new therapeutic modalities.

Original languageEnglish
Pages (from-to)1204-1210
Number of pages7
JournalAmerican Journal of Gastroenterology
Volume97
Issue number5
DOIs
Publication statusPublished - 2002

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Chronic Hepatitis C
Interferons
Multicenter Studies
Iron
Phlebotomy
Hepacivirus
Genotype
Therapeutics
Liver
RNA
Reference Values
Multivariate Analysis
Odds Ratio

ASJC Scopus subject areas

  • Gastroenterology

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Iron reduction and sustained response to interferon-α therapy in patients with chronic hepatitis C : Results of an Italian multicenter randomized study. / Fargion, Silvia; Fracanzani, Anna Ludovica; Rossini, Angelo; Borzio, Mauro; Riggio, Oliviero; Belloni, Giovanni; Bissoli, Franco; Ceriani, Roberto; Ballarè, Marco; Massari, Marco; Trischitta, Caterina; Fiore, Pierluigi; Orlandi, Anna; Morini, Lorenzo; Mattioli, Michela; Oldani, Silvia; Cesana, Bruno; Fiorelli, Gemino.

In: American Journal of Gastroenterology, Vol. 97, No. 5, 2002, p. 1204-1210.

Research output: Contribution to journalArticle

Fargion, S, Fracanzani, AL, Rossini, A, Borzio, M, Riggio, O, Belloni, G, Bissoli, F, Ceriani, R, Ballarè, M, Massari, M, Trischitta, C, Fiore, P, Orlandi, A, Morini, L, Mattioli, M, Oldani, S, Cesana, B & Fiorelli, G 2002, 'Iron reduction and sustained response to interferon-α therapy in patients with chronic hepatitis C: Results of an Italian multicenter randomized study', American Journal of Gastroenterology, vol. 97, no. 5, pp. 1204-1210. https://doi.org/10.1016/S0002-9270(02)04061-3
Fargion, Silvia ; Fracanzani, Anna Ludovica ; Rossini, Angelo ; Borzio, Mauro ; Riggio, Oliviero ; Belloni, Giovanni ; Bissoli, Franco ; Ceriani, Roberto ; Ballarè, Marco ; Massari, Marco ; Trischitta, Caterina ; Fiore, Pierluigi ; Orlandi, Anna ; Morini, Lorenzo ; Mattioli, Michela ; Oldani, Silvia ; Cesana, Bruno ; Fiorelli, Gemino. / Iron reduction and sustained response to interferon-α therapy in patients with chronic hepatitis C : Results of an Italian multicenter randomized study. In: American Journal of Gastroenterology. 2002 ; Vol. 97, No. 5. pp. 1204-1210.
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abstract = "OBJECTIVES: It has been suggested that iron depletion improves the response to interferon in patients with chronic hepatitis C. We aimed to evaluate whether iron reduction by phlebotomy before interferon improves the rate of virological sustained response in previously untreated noncirrhotic patients. METHODS: One hundred fourteen hepatitis C virus (HCV) RNA positive patients with hepatic iron concentrations of ≥700 μg/g dry wt (men) and ≥500 μg/g dry wt (women), stratified according to HCV genotype and γ-glutamyltransferase values, were randomly allocated to interferon alone (6 MU three times a week) (group A) or to phlebotomy until iron depletion followed by interferon (6 MU three times a week) (group B). After 4 months dosage was reduced to 3 MU three times a week for another 8 months. RESULTS: Virological sustained response was observed in 25 patients (22{\%}), nine (15.8{\%}, 95{\%} CI = 7.5-27.9) of group A and 16 (28.1{\%}, 95{\%} CI = 17.0-41.6) of group B. At univariate analysis the variables associated with the response were HCV genotypes 2-3, normal γ-glutamyltransferase, higher levels of baseline ALT, normal ALT values, and negativity for HCV-RNA at the 3rd month of therapy. At multivariate analysis, genotype and ALT levels at enrollment maintained their association with the response. A trend toward a better response to interferon was observed in patients who received phlebotomy (odds ratio = 2.32, 95{\%} CI = 0.96-6.24, p = 0.082). Patients with hepatic iron concentration of ≤1100 μg/g dry wt had a trend toward a higher rate of virological sustained response (p = 0.059) when submitted to treatment B. CONCLUSION: Iron removal by phlebotomy is able to improve the rate of response to interferon, especially in patients with lower hepatic iron deposits; it could be useful as adjuvant therapy to new therapeutic modalities.",
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T1 - Iron reduction and sustained response to interferon-α therapy in patients with chronic hepatitis C

T2 - Results of an Italian multicenter randomized study

AU - Fargion, Silvia

AU - Fracanzani, Anna Ludovica

AU - Rossini, Angelo

AU - Borzio, Mauro

AU - Riggio, Oliviero

AU - Belloni, Giovanni

AU - Bissoli, Franco

AU - Ceriani, Roberto

AU - Ballarè, Marco

AU - Massari, Marco

AU - Trischitta, Caterina

AU - Fiore, Pierluigi

AU - Orlandi, Anna

AU - Morini, Lorenzo

AU - Mattioli, Michela

AU - Oldani, Silvia

AU - Cesana, Bruno

AU - Fiorelli, Gemino

PY - 2002

Y1 - 2002

N2 - OBJECTIVES: It has been suggested that iron depletion improves the response to interferon in patients with chronic hepatitis C. We aimed to evaluate whether iron reduction by phlebotomy before interferon improves the rate of virological sustained response in previously untreated noncirrhotic patients. METHODS: One hundred fourteen hepatitis C virus (HCV) RNA positive patients with hepatic iron concentrations of ≥700 μg/g dry wt (men) and ≥500 μg/g dry wt (women), stratified according to HCV genotype and γ-glutamyltransferase values, were randomly allocated to interferon alone (6 MU three times a week) (group A) or to phlebotomy until iron depletion followed by interferon (6 MU three times a week) (group B). After 4 months dosage was reduced to 3 MU three times a week for another 8 months. RESULTS: Virological sustained response was observed in 25 patients (22%), nine (15.8%, 95% CI = 7.5-27.9) of group A and 16 (28.1%, 95% CI = 17.0-41.6) of group B. At univariate analysis the variables associated with the response were HCV genotypes 2-3, normal γ-glutamyltransferase, higher levels of baseline ALT, normal ALT values, and negativity for HCV-RNA at the 3rd month of therapy. At multivariate analysis, genotype and ALT levels at enrollment maintained their association with the response. A trend toward a better response to interferon was observed in patients who received phlebotomy (odds ratio = 2.32, 95% CI = 0.96-6.24, p = 0.082). Patients with hepatic iron concentration of ≤1100 μg/g dry wt had a trend toward a higher rate of virological sustained response (p = 0.059) when submitted to treatment B. CONCLUSION: Iron removal by phlebotomy is able to improve the rate of response to interferon, especially in patients with lower hepatic iron deposits; it could be useful as adjuvant therapy to new therapeutic modalities.

AB - OBJECTIVES: It has been suggested that iron depletion improves the response to interferon in patients with chronic hepatitis C. We aimed to evaluate whether iron reduction by phlebotomy before interferon improves the rate of virological sustained response in previously untreated noncirrhotic patients. METHODS: One hundred fourteen hepatitis C virus (HCV) RNA positive patients with hepatic iron concentrations of ≥700 μg/g dry wt (men) and ≥500 μg/g dry wt (women), stratified according to HCV genotype and γ-glutamyltransferase values, were randomly allocated to interferon alone (6 MU three times a week) (group A) or to phlebotomy until iron depletion followed by interferon (6 MU three times a week) (group B). After 4 months dosage was reduced to 3 MU three times a week for another 8 months. RESULTS: Virological sustained response was observed in 25 patients (22%), nine (15.8%, 95% CI = 7.5-27.9) of group A and 16 (28.1%, 95% CI = 17.0-41.6) of group B. At univariate analysis the variables associated with the response were HCV genotypes 2-3, normal γ-glutamyltransferase, higher levels of baseline ALT, normal ALT values, and negativity for HCV-RNA at the 3rd month of therapy. At multivariate analysis, genotype and ALT levels at enrollment maintained their association with the response. A trend toward a better response to interferon was observed in patients who received phlebotomy (odds ratio = 2.32, 95% CI = 0.96-6.24, p = 0.082). Patients with hepatic iron concentration of ≤1100 μg/g dry wt had a trend toward a higher rate of virological sustained response (p = 0.059) when submitted to treatment B. CONCLUSION: Iron removal by phlebotomy is able to improve the rate of response to interferon, especially in patients with lower hepatic iron deposits; it could be useful as adjuvant therapy to new therapeutic modalities.

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