Lamivudine vs lamivudine and interferon combination treatment of HBeAg(−) chronic hepatitis B

Authors

  • C. Yurdaydin,

    1. Department of Gastroenterology, Pathology and the Hepatology Institute, University of Ankara Medical School; and Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey
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  • H. Bozkaya,

    1. Department of Gastroenterology, Pathology and the Hepatology Institute, University of Ankara Medical School; and Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey
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  • H. Çetinkaya,

    1. Department of Gastroenterology, Pathology and the Hepatology Institute, University of Ankara Medical School; and Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey
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  • T. Şahin,

    1. Department of Gastroenterology, Pathology and the Hepatology Institute, University of Ankara Medical School; and Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey
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  • D. Karaoğuz,

    1. Department of Gastroenterology, Pathology and the Hepatology Institute, University of Ankara Medical School; and Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey
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  • M. Törüner,

    1. Department of Gastroenterology, Pathology and the Hepatology Institute, University of Ankara Medical School; and Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey
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  • Ö. Erkan,

    1. Department of Gastroenterology, Pathology and the Hepatology Institute, University of Ankara Medical School; and Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey
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  • A. O. Heper,

    1. Department of Gastroenterology, Pathology and the Hepatology Institute, University of Ankara Medical School; and Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey
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  • E. Erden,

    1. Department of Gastroenterology, Pathology and the Hepatology Institute, University of Ankara Medical School; and Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey
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  • A. M. Bozdayi,

    1. Department of Gastroenterology, Pathology and the Hepatology Institute, University of Ankara Medical School; and Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey
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  • Ö. Uzunalimoğlu

    1. Department of Gastroenterology, Pathology and the Hepatology Institute, University of Ankara Medical School; and Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey
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Cihan Yurdaydın, Department of Gastroenterology, University of Ankara Medical School, Cebeci Tıp Fakültesi Hastanesi, 06100 Dikimevi, Ankara, Turkey. E-mail: cihan.yurdaydin@dialup.ankara.edu.tr

Abstract

Summary.  To determine whether combination treatment of HBeAg(−) chronic hepatitis B is beneficial we studied 78 patients with HBeAg(−), HBV DNA-positive chronic hepatitis B who were randomized to lamivudine, 100 mg, qd, for 12 months or lamivudine–interferon (9 MU, t.i.w.) in combination. In the combination arm, 2 months of lamivudine treatment preceded 10 months of combination treatment. Biochemical, virologic and histologic responses were assessed at the end of treatment, after six and a median 27 months of drug-free follow-up (short- and long-term follow-up, respectively). Virologic response was defined as undetectable HBV DNA with a hybridization assay and biochemical response as normal alanine aminotransferase (ALT). Change in HBV DNA was also assessed by real-time polymerase chain reaction (PCR). Presence of YMDD mutants at the end of treatment was investigated with a line probe assay. Both treatment regimes led to a median 2 log decline in HBV DNA levels. Virologic end of treatment responses were 90 and 92% with mono- and combination treatment, respectively. Corresponding virologic responses at short- and long-term follow-up were 59 and 54%, and 27 and 25%, respectively. Patients having a baseline HBV DNA value ≥200 pg/mL were more likely to relapse within 6 months off therapy than those patients with a baseline HBV DNA level <200 pg/mL (P = 0.041). YMDD mutants were observed in 53% of patients receiving lamivudine compared with 24% of patients receiving the combination regime (P = 0.017). In conclusion, efficay of combination treatment is similar to lamivudine monotherapy. However, combination treatment decreases the development of YMDD mutant strains compared with lamivudine monotherapy.

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