Combination Therapy with PEG-Intron and

OCD

Epivir-HBV is Superior to Epivir-HBV Monotherapy for Chronic Hepatitis B

Abstract Summary
Previous studies combining interferon with Epivir-HBV (lamivudine) have failed to prove an additional benefit in clearance of HBV infection. Researchers in Hong Kong studied the antiviral effects of PEG-Intron (pegylated interferon alfa-2b/Peg-IFN) and lamivudine combination.

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.

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.

03/28/03

Reference
JJY Sung and others. COMBINATION OF PEGYLATED INTERFERON AND LAMIVUDINE IS SUPERIOR TO LAMIVUDINE MONOTHERAPY IN THE TREATMENT OF CHRONIC HEPATITIS B - A RANDOMIZED TRIAL. Abstract 3105.00. Abstracts of the 38th Annual Meeting of the European Association of the Study of the Liver (EASL).

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