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Pegylated
Interferon Alfa-2b Alone or in Combination with Lamivudine for HBeAg-positive
Chronic Hepatitis B: Results of a Randomised Trial
The Lancet has published results of
a large multi-center, randomized, international trial conducted
in 15 countries comparing the safety and effectiveness of peginterferon
alfa-2b (Peg Intron) alone (monotherapy) or in combination with
lamivudine (Epivir-HBV; Zeffix) among patients with chronic hepatitis
B who are HBeAg-positive.
Following is a summary of the study that appears in the January
8, 2005 issue of The Lancet:
Treatment
of HBeAg-positive patients with chronic hepatitis B is not effective
in most cases. Researchers evaluated whether a combination of the
immunomodulatory agent pegylated
interferon alfa-2b (Peg Intron) and the antiviral drug lamivudine
might improve the rate of sustained response.
307
HBeAg-positive patients with chronic hepatitis B were assigned combination
therapy (100 microgram/week pegylated interferon alfa-2b and 100
mg/day lamivudine) or monotherapy (100 microgram/week pegylated
interferon alfa-2b and placebo) for 52 weeks.
During
weeks 32–52 the pegylated interferon dose was 50 microgram/week
in both treatment groups.
The analyses were based on the modified intention-to-treat population
after exclusion of 24 patients from one centre withdrawn for misconduct,
ten who lost HBeAg before the study start, and seven who received
no study medication. All included patients were followed up for
26 weeks after treatment.
Results
49
(36%) of 136 patients assigned monotherapy and 46 (35%) of 130 assigned
combination therapy had lost HBeAg at the end of follow-up (p=0·91).
More of the combination-therapy than of the monotherapy group had
cleared HBeAg at the end of treatment (57 [44%] vs 40 [29%]; p=0·01)
but relapsed during follow-up. Patterns were similar when response
was assessed by suppression of serum hepatitis B virus (HBV) DNA
or change in concentrations of alanine aminotransferase.
Response
rates (HBeAg loss) varied by HBV genotype (p=0·01): A, 42 (47%)
patients; B, ten (44%); C, 11 (28%); and D, 26 (25%).
Conclusions
The
authors conclude:
Treatment with pegylated interferon alfa-2b is effective for HBeAg-positive
chronic hepatitis B;
Combination with lamivudine in the regimen used
is not superior to monotherapy;
HBV genotype is an important predictor of response
to treatment.
Press
Release on study results and implications from Erasmus Medical Center
01/07/05
Reference
H L A Janssen and others (for the HBV
99 -01 Study Group). Pegylated interferon alfa-2b alone or in combination
with lamivudine for HBeAg-positive chronic hepatitis B: a randomised
trial. The Lancet 365: 123 -129. January 8, 2005.
Additional HIVandHepatitis.com Articles:
- Articles on HBV
Experimental PEG-Intron - Monotherapy
- Articles on HBV
Experimental PEG-Intron plus Epivir-HBV - Combination
Link to Index to All Hepatitis B Articles
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