Peg对1/3的INF和LAM失效患者有效(AASLD11.17)

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Peginterferon Alfa Is Effective in Almost One-third of Patients Who Failed Previous Treatment with Standard Interferon or Lamivudine

Treatment with antiviral therapy is effective in 20-30% of HBeAg-positive chronic hepatitis B (CHB). Non-response to treatment may result in progression of liver disease and increased risk of hepatocellular carcinoma.

As part of a global randomized controlled trial researchers investigated the efficacy (i.e. loss of HBeAg at end of follow-up) of pegylated interferon (PEG-IFN) in CHB who failed to respond to previous courses of standard interferon or lamivudine. Researchers analyzed 59 non-responders to previous standard IFN and 39 non-responders to previous lamivudine therapy. All patients received a 52-week course of 100礸 PEG-IFN weekly combined with either 100mg lamivudine or placebo daily. After therapy patients were followed for 24 weeks. Median treatment duration was 24 weeks (range 3 - 52) for previous standard IFN (median dose 18 MU/week), and 52 weeks (range 2 - 411) for previous treatment with lamivudine. Median interval until retreatment was 119 weeks (range 26 - 576) and 43 weeks (range 28 - 366) for prior IFN and lamivudine, respectively.

Results

Eleven patients had a YMDD-mutant at start of Peg-IFN therapy. Seventeen (29%) non-responders to previous IFN and 9 (23%) non-responders to previous lamivudine responded (loss of HBeAg at end of follow-up) to treatment with Peg-IFN.

Treatment with the combination of Peg-IFN and lamivudine was not superior to Peg-IFN alone. Non-responders to prior IFN therapy with baseline ALT above 4 x ULN responded better to Peg-IFN than those with ALT levels below 4 x ULN (44% vs. 16 % respectively, p = 0.019).

A similar trend was found for non-responders to previous lamivudine with ALT above vs. below 4 x ULN (response 37% vs. 13%, respectively; p = 0.089). In conclusion, Peg-IFN is effective in almost one-third of patients who failed previous treatment with standard IFN or lamivudine. High ALT levels at baseline of Peg-IFN therapy was the best predictor for increased response in prior non-responders to either standard IFN or lamivudine therapy.

Reference H J Flink and others. SUCCESSFUL TREATMENT WITH PEGYLATED INTERFERON IN HBV NON-RESPONDERS TO STANDARD INTERFERON AND LAMIVUDINE. Abstract 1150 (poster). 55th AASLD. October 29-November 2, 2004. Boston, MA.