Viral Hepatitis
Copyright ©The Author(s) 2003. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jul 15, 2003; 9(7): 1491-1495
Published online Jul 15, 2003. doi: 10.3748/wjg.v9.i7.1491
Long-term alpha interferon and lamivudine combination therapy in non-responder patients with anti-HBe-positive chronic hepatitis B: Results of an open, controlled trial
M. Francesca Jaboli, Carlo Fabbri, Stefania Liva, Francesco Azzaroli, Giovanni Nigro, Silvia Giovanelli, Francesco Ferrara, Anna Miracolo, Sabrina Marchetto, Marco Montagnani, Antonio Colecchia, Davide Festi, Letizia Bacchi Reggiani, Enrico Roda, Giuseppe Mazzella
M. Francesca Jaboli, Stefania Liva, Francesco Azzaroli, Giovanni Nigro, Silvia Giovanelli, Francesco Ferrara, Anna Miracolo, Sabrina Marchetto, Marco Montagnani, Antonio Colecchia, Enrico Roda, Mazzella Giuseppe, Department of Internal Medicine and Gastroenterology, University of Bologna, Italy
Carlo Fabbri, Department of Gastroenterology and Gastrointestinal Endoscopy, Bellaria Hospital, Bologna, Italy
Davide Festi, Department of Medicine and Aging, University of Chieti, Italy
Letizia Bacchi Reggiani, Department of Cardiology, University of Bologna, Italy
Author contributions: All authors contributed equally to the work.
Correspondence to: Professor Giuseppe Mazzella, Department of Internal Medicine and Gastroenterology, University of Bologna, Ospedale S. Orsola- Malpighi, via Massarenti 9, 40138 Bologna, Italy. mazzella@med.unibo.it
Telephone: +39-51-6363276 Fax: +39-51-300700
Received: February 25, 2003
Revised: March 4, 2003
Accepted: March 16, 2003
Published online: July 15, 2003
Abstract

AIM: To investigate the safety and efficacy of long-term combination therapy with alpha interferon and lamivudine in non-responsive patients with anti-HBe-positive chronic hepatitis B.

METHODS: 34 patients received combination treatment (1 month lamivudine, 12 month lamivudine+interferon, 6 month lamivudine), 24 received lamivudine (12 mo), 24 received interferon (12 mo). Interferon was administered at 6 MU tiw and lamivudine at 100 mg orally once daily. Patients were followed up for 6 mo after treatment.

RESULTS: At the end of treatment, HBV DNA negativity rates were 88% with lamivudine + interferon, 99% with lamivudine and 55% with interferon, (P = 0.004, combination therapy vs. interferon, and P = 0.001 lamivudine vs. interferon), and serum transaminase normalization rates were 84%, 91% and 53% (P = 0.01 combination therapy vs. interferon, and P = 0.012 lamivudine vs. interferon). Six months later, HBV DNA negativity rates were 44% with lamivudine+interferon, 33% with lamivudine and 25% with interferon, and serum transaminase normalization rates were 61%, 42% and 45%, respectively, without statistical significance. No YMDD variants were observed with lamivudine+interferon (vs. 12% with lamivudine). The combination therapy appeared to be safe.

CONCLUSION: Although viral clearance and transaminase normalization are slower with long-term lamivudine + interferon than that with lamivudine alone, the combination regimen seems to provide more lasting benefits and to protect against the appearance of YMDD variants. Studies with other regimens regarding sequence and duration are needed.

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