A randomized, controlled trial of a 24-month course of interferon alfa 2b in patients with chronic hepatitis B who had hepatitis B virus DNA without hepatitis B e antigen in serum

Pietro Lampertico, Ersilio Del Ninno, Aldo Manzin, Maria Francesca Donato, Maria Grazia Rumi, Giovanna Lunghi, Alberto Morabito, Massimo Clementi, Massimo Colombo

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Abstract

Short-term interferon treatment of serum hepatitis B e antigen (HBeAg)- negative carriers with serum hepatitis B virus (HBV) DNA and histological features of chronic hepatitis B has been largely unsuccessful. In a pilot study of long-term treatment, 42 such patients were randomly assigned to 6 million units of interferon alfa 2b (IFN-α2b) three times per week for 24 consecutive months (n = 21, 4 with cirrhosis) or to no therapy (n = 21, 3 with cirrhosis). Five patients (24%) discontinued therapy because of treatment-related adverse reactions. Serum levels of alanine transaminase (ALT) became persistently normal and HBV DNA undetectable by dot-blot assay in 8 patients receiving interferon and in 2 untreated controls (38% vs. 10%; P = .03). Hepatitis flare-ups disappeared in 17 patients during therapy compared with 6 controls (81% vs. 29%; P <.001). During a median period of 22 months after interferon was stopped, 2 treated patients (10%) lost serum hepatitis B surface antigen (HBsAg) and seroconverted to antibodies to hepatitis B surface antigen (anti-HBs). Serum ALT remained persistently normal and HBV DNA undetectable by dot-blot assay in 6 initial responders and 1 initial nonresponder, compared with none of the 21 untreated controls (sustained response: 33% vs. 0; P <.001). Comparative analysis of pre- and posttreatment liver biopsies showed that mean Knodell scores dropped in the treatment group (10.3 to 53; P = .01), but not in the untreated group (9.3 to 9.8; not significant). In conclusion, a 24-month course of treatment with 6 MU IFN-α2b was well tolerated by most patients, led to sustained suppression of HBV in one third, and attenuated hepatitis in 81% of patients.

Original languageEnglish
Pages (from-to)1621-1625
Number of pages5
JournalHepatology
Volume26
Issue number6
Publication statusPublished - 1997

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interferon alfa-2b
Hepatitis B e Antigens
Chronic Hepatitis B
Hepatitis B virus
Randomized Controlled Trials
DNA
Serum
Interferons
Therapeutics
Hepatitis B Surface Antigens
Alanine Transaminase
Hepatitis
Fibrosis

ASJC Scopus subject areas

  • Hepatology

Cite this

@article{b7e19e4e7ab248f2b75f75b14b33e163,
title = "A randomized, controlled trial of a 24-month course of interferon alfa 2b in patients with chronic hepatitis B who had hepatitis B virus DNA without hepatitis B e antigen in serum",
abstract = "Short-term interferon treatment of serum hepatitis B e antigen (HBeAg)- negative carriers with serum hepatitis B virus (HBV) DNA and histological features of chronic hepatitis B has been largely unsuccessful. In a pilot study of long-term treatment, 42 such patients were randomly assigned to 6 million units of interferon alfa 2b (IFN-α2b) three times per week for 24 consecutive months (n = 21, 4 with cirrhosis) or to no therapy (n = 21, 3 with cirrhosis). Five patients (24{\%}) discontinued therapy because of treatment-related adverse reactions. Serum levels of alanine transaminase (ALT) became persistently normal and HBV DNA undetectable by dot-blot assay in 8 patients receiving interferon and in 2 untreated controls (38{\%} vs. 10{\%}; P = .03). Hepatitis flare-ups disappeared in 17 patients during therapy compared with 6 controls (81{\%} vs. 29{\%}; P <.001). During a median period of 22 months after interferon was stopped, 2 treated patients (10{\%}) lost serum hepatitis B surface antigen (HBsAg) and seroconverted to antibodies to hepatitis B surface antigen (anti-HBs). Serum ALT remained persistently normal and HBV DNA undetectable by dot-blot assay in 6 initial responders and 1 initial nonresponder, compared with none of the 21 untreated controls (sustained response: 33{\%} vs. 0; P <.001). Comparative analysis of pre- and posttreatment liver biopsies showed that mean Knodell scores dropped in the treatment group (10.3 to 53; P = .01), but not in the untreated group (9.3 to 9.8; not significant). In conclusion, a 24-month course of treatment with 6 MU IFN-α2b was well tolerated by most patients, led to sustained suppression of HBV in one third, and attenuated hepatitis in 81{\%} of patients.",
author = "Pietro Lampertico and {Del Ninno}, Ersilio and Aldo Manzin and Donato, {Maria Francesca} and Rumi, {Maria Grazia} and Giovanna Lunghi and Alberto Morabito and Massimo Clementi and Massimo Colombo",
year = "1997",
language = "English",
volume = "26",
pages = "1621--1625",
journal = "Hepatology",
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T1 - A randomized, controlled trial of a 24-month course of interferon alfa 2b in patients with chronic hepatitis B who had hepatitis B virus DNA without hepatitis B e antigen in serum

AU - Lampertico, Pietro

AU - Del Ninno, Ersilio

AU - Manzin, Aldo

AU - Donato, Maria Francesca

AU - Rumi, Maria Grazia

AU - Lunghi, Giovanna

AU - Morabito, Alberto

AU - Clementi, Massimo

AU - Colombo, Massimo

PY - 1997

Y1 - 1997

N2 - Short-term interferon treatment of serum hepatitis B e antigen (HBeAg)- negative carriers with serum hepatitis B virus (HBV) DNA and histological features of chronic hepatitis B has been largely unsuccessful. In a pilot study of long-term treatment, 42 such patients were randomly assigned to 6 million units of interferon alfa 2b (IFN-α2b) three times per week for 24 consecutive months (n = 21, 4 with cirrhosis) or to no therapy (n = 21, 3 with cirrhosis). Five patients (24%) discontinued therapy because of treatment-related adverse reactions. Serum levels of alanine transaminase (ALT) became persistently normal and HBV DNA undetectable by dot-blot assay in 8 patients receiving interferon and in 2 untreated controls (38% vs. 10%; P = .03). Hepatitis flare-ups disappeared in 17 patients during therapy compared with 6 controls (81% vs. 29%; P <.001). During a median period of 22 months after interferon was stopped, 2 treated patients (10%) lost serum hepatitis B surface antigen (HBsAg) and seroconverted to antibodies to hepatitis B surface antigen (anti-HBs). Serum ALT remained persistently normal and HBV DNA undetectable by dot-blot assay in 6 initial responders and 1 initial nonresponder, compared with none of the 21 untreated controls (sustained response: 33% vs. 0; P <.001). Comparative analysis of pre- and posttreatment liver biopsies showed that mean Knodell scores dropped in the treatment group (10.3 to 53; P = .01), but not in the untreated group (9.3 to 9.8; not significant). In conclusion, a 24-month course of treatment with 6 MU IFN-α2b was well tolerated by most patients, led to sustained suppression of HBV in one third, and attenuated hepatitis in 81% of patients.

AB - Short-term interferon treatment of serum hepatitis B e antigen (HBeAg)- negative carriers with serum hepatitis B virus (HBV) DNA and histological features of chronic hepatitis B has been largely unsuccessful. In a pilot study of long-term treatment, 42 such patients were randomly assigned to 6 million units of interferon alfa 2b (IFN-α2b) three times per week for 24 consecutive months (n = 21, 4 with cirrhosis) or to no therapy (n = 21, 3 with cirrhosis). Five patients (24%) discontinued therapy because of treatment-related adverse reactions. Serum levels of alanine transaminase (ALT) became persistently normal and HBV DNA undetectable by dot-blot assay in 8 patients receiving interferon and in 2 untreated controls (38% vs. 10%; P = .03). Hepatitis flare-ups disappeared in 17 patients during therapy compared with 6 controls (81% vs. 29%; P <.001). During a median period of 22 months after interferon was stopped, 2 treated patients (10%) lost serum hepatitis B surface antigen (HBsAg) and seroconverted to antibodies to hepatitis B surface antigen (anti-HBs). Serum ALT remained persistently normal and HBV DNA undetectable by dot-blot assay in 6 initial responders and 1 initial nonresponder, compared with none of the 21 untreated controls (sustained response: 33% vs. 0; P <.001). Comparative analysis of pre- and posttreatment liver biopsies showed that mean Knodell scores dropped in the treatment group (10.3 to 53; P = .01), but not in the untreated group (9.3 to 9.8; not significant). In conclusion, a 24-month course of treatment with 6 MU IFN-α2b was well tolerated by most patients, led to sustained suppression of HBV in one third, and attenuated hepatitis in 81% of patients.

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