PegIntron for Treatment of Hepatitis B Patients Who Did Not Respond to Prior Therapy

Antiviral therapy leads to hepatitis B "e" antigen (HBeAg) seroconversion in 10%-40% of the patients with HBeAg-positive chronic hepatitis B. Unfortunately, patients who do not respond to treatment may experience progression of liver disease and increased risk of hepatocellular carcinoma.

As part of a global randomized controlled trial, researchers from the Netherlands assessed the efficacy - defined as loss of HBeAg at the end of follow-up - of pegylated interferon alfa-2b (PegIntron) in patients who did not respond to previous courses of standard interferon or lamivudine (Epivir-HBV).

The investigators analyzed data from 76 previous non-responders: 37 non-responders to standard interferon, 17 non-responders to lamivudine, and 22 non-responders to both therapies. Patients received a 52-week course of 100 mcg once-weekly PegIntron combined with either 100 mg daily lamivudine or placebo. After therapy patients were followed for 26 weeks.

Results

• 13 non-responders to previous standard interferon (35%), 5 non-responders to previous lamivudine (29%), and 4 non-responders to both therapies (22%) responded to treatment with PegIntron.

• No difference in response was observed between those treated with PegIntron alone or in combination with lamivudine.

• Non-responders to prior standard interferon with baseline alanine aminotransferase (ALT) levels more than 4 times the upper limit of normal (x ULN) responded better to PegIntron than those with ALT levels of 4 x ULN or lees (53% vs 20%, respectively; P = 0.036).

Conclusion

"[Pegylated interferon alfa-2b] is effective in approximately one-third of patients who failed to respond to previous treatment with standard interferon or lamivudine," the authors concluded. "High serum ALT level at baseline of [pegylated interferon alfa-2b] therapy was the best predictor for response in these patients."

1/09/07

Reference
H J Flink, B E Hansen, E J Heathcote, and others. Successful treatment with peginterferon alfa-2b of HBeAg-positive HBV non-responders to standard interferon or lamivudine. American Journal of Gastroenterology 101(11): 2523-2529. November 2006.

HEPATITIS B
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