A randomized controlled trial of lymphoblastoid interferon‐α in patients with chronic hepatitis B lacking HBeAg

Ongoing hepatitis B virus replication in the presence of antibody to HBeAg can be observed in patients with active liver disease. These forms of chronic hepatitis B have been described as having a poor prognosis. We have conducted a randomized controlled trial to assess the efficacy of lymphoblastoi...

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Veröffentlicht in:Hepatology (Baltimore, Md.) Md.), 1992-04, Vol.15 (4), p.584-589
Hauptverfasser: Fattovich, Giovanna, Farci, Patrizia, Rugge, Massimo, Brollo, Lucio, Mandas, Antonella, Pontisso, Patrizia, Giustina, Giuliano, Lai, M. Eliana, Belussi, Fabio, Busatto, Graziella, Balestrieri, Angelo, Ruol, Arturo, Alberti, Alfredo
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container_title Hepatology (Baltimore, Md.)
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creator Fattovich, Giovanna
Farci, Patrizia
Rugge, Massimo
Brollo, Lucio
Mandas, Antonella
Pontisso, Patrizia
Giustina, Giuliano
Lai, M. Eliana
Belussi, Fabio
Busatto, Graziella
Balestrieri, Angelo
Ruol, Arturo
Alberti, Alfredo
description Ongoing hepatitis B virus replication in the presence of antibody to HBeAg can be observed in patients with active liver disease. These forms of chronic hepatitis B have been described as having a poor prognosis. We have conducted a randomized controlled trial to assess the efficacy of lymphoblastoid interferon‐α in 60 patients with antibody to HBeAg and hepatitis B virus DNA–positive chronic hepatitis. Patients received 5 million U/m2 interferon three times a week for 6 mo, or no treatment. Final evaluation 18 mo after randomization showed hepatitis B virus DNA negativity and ALT normalization in 53% of treated patients and in 17% of controls (p < 0.01). The probability of sustained hepatitis B virus DNA loss was significantly higher in treated patients than in controls (p < 0.005). Blinded histological assessment revealed improvement in 50% of treated patients compared with 33% of controls. Pretreatment hepatitis B virus DNA and aminotransferase levels and histological appearance were not predictive of response. The results of this trial indicated that marked reduction of viral replication in serum and remission of liver damage can be obtained with lymphoblastoid interferon in about 50% of patients with HBeAg antibody– and HBV DNA–positive chronic hepatitis. This rate of response is higher than that reported previously. (Hepatology 1992;15:584–589).
doi_str_mv 10.1002/hep.1840150405
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Final evaluation 18 mo after randomization showed hepatitis B virus DNA negativity and ALT normalization in 53% of treated patients and in 17% of controls (p &lt; 0.01). The probability of sustained hepatitis B virus DNA loss was significantly higher in treated patients than in controls (p &lt; 0.005). Blinded histological assessment revealed improvement in 50% of treated patients compared with 33% of controls. Pretreatment hepatitis B virus DNA and aminotransferase levels and histological appearance were not predictive of response. The results of this trial indicated that marked reduction of viral replication in serum and remission of liver damage can be obtained with lymphoblastoid interferon in about 50% of patients with HBeAg antibody– and HBV DNA–positive chronic hepatitis. This rate of response is higher than that reported previously. 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subjects Adult
Antibiotics. Antiinfectious agents. Antiparasitic agents
Biological and medical sciences
Biopsy
Chronic Disease
DNA, Viral - analysis
Female
Hepatitis B - immunology
Hepatitis B - pathology
Hepatitis B - therapy
Hepatitis B e Antigens - analysis
Hepatitis B virus - genetics
Humans
Interferon-gamma - adverse effects
Interferon-gamma - therapeutic use
Liver - pathology
Male
Medical sciences
Pharmacology. Drug treatments
title A randomized controlled trial of lymphoblastoid interferon‐α in patients with chronic hepatitis B lacking HBeAg
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