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COMBINATION OF PEGYLATED INTERFERON AND LAMIVUDINE IS SUPERIOR TO LAMIVUDINE MONOTHERAPY IN THE TREATMENT OF CHRONIC HEPATITIS B - A RANDOMIZED TRIAL
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J.J.Y. Sung*, H.L.Y. Chan, A.Y. Hui, F.K.L. Chan, A.M.L. Chim,
M.L. Wong, N.W.Y. Leung,
Department Of Medicine & Therapeutics, Chinese University Of Hong Kong, Hong Kong
Background: Previous studies combining interferon with lamivudine failed to prove additional benefit in clearance of HBV infection. We aimed to study the anti-viral effects of pegylated interferon (Peg-IFN) and lamivudine combination.
Patients and Methods: Treatment-naive chronic hepatitis B patients who had positive HBeAg, HBV DNA >1, 000, 000 copies/ml and ALT 1.3-5X upper limit of normal were recruited into an open-labeled, randomized study. Patients received either combination treatment (Combo group) with Peg-IFN 1.5 mcg/kg for 8 weeks, then Peg-IFN plus lamivudine 100mg daily for 24 weeks followed by lamivudine alone for 28 weeks, or lamivudine monotherapy 100mg daily for 52 weeks (Lam group). End-of-treatment and sustained (24-week post-treatment) virological response (VR, defined as HBeAg seroconversion and undetectable HBV DNA) and biochemical response (BR, defined as normalization of ALT) were analyzed.
Results: The interim results of first 40 patients who finished treatment and follow-up were analyzed. There was no difference in the gender, age and ALT levels between the two groups.
The proportion of patients achieving end-of-treatment and sustained VR in Combo group was significantly higher than that of Lam group (75% vs 25%, p=0.0005 and 50% vs 10%, p=0.02 respectively).
There was no significant difference in the end-of-treatment and sustained BR between the Combo and Lam groups (95% vs 70%, p=0.1 and 50% vs 30%, p=0.3 respectively).
Four patients receiving Peg-IFN had premature termination of treatment due to serious adverse events.
Conclusion: Combination of Peg-IFN and lamivudine has superior anti-viral effect to lamivudine monotherapy in the treatment of chronic hepatitis B infection.
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