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Efficacy of 12-month Famciclovir Treatment in Chronic HBeAg-positive
Patients
The
current standard of therapy for chronic
hepatitis B e antigen (HBeAg)-positive infection is interferon-alfa.
However, its efficacy, based on seroconversion, is only 30 percent.
In this randomized, placebo-controlled, multicenter study, researchers
evaluated the efficacy of 12 months of famciclovir/FAM
(Famvir) therapy in 417 HBeAg-positive patients.
FAM
is a nucleoside analog that has been licensed for the treatment
of varicella zoster and herpes
simplex suppression.
Researchers
at the University of Rotterdam, The Netherlands conducted a randomized,
placebo-controlled clinical study evaluating famciclovir (500 mg
3 times daily and 1.5 g once daily) for 1 year (6 months post-treatment
follow-up) in patients with chronic hepatitis B e antigen (HBeAg)-positive
hepatitis B virus (HBV) infection.
The
study was conducted in 80 centers in North America, Europe, and
Australia/New Zealand.
A
total of 417 patients with histologically documented chronic hepatitis
B (histologic activity index [HAI] 9.5-11.0) received famciclovir
(500 mg 3 times daily or 1.5 g once daily) or placebo.
Results
Famciclovir
500 mg 3 times daily significantly reduced HBV DNA and median HAI
scores versus placebo.
By
week 8, median HBV DNA decreased from 1,645 to 283 MEq/mL (famciclovir
500 mg 3 times daily) and from 1,147 to 304 MEq/mL (famciclovir
1.5 g once daily), while increasing for placebo (1,617 to 1,685
MEq/mL).
Median
change in HBV DNA at the end of therapy was -76% (famciclovir 500
mg 3 times daily; P <.01) and -60% (famciclovir 1.5 g once daily;
P =.25) versus -37% for placebo.
Median
change in HAI was -1.5 points (famciclovir 500 mg 3 times daily;
P =.02) and -1.0 point (famciclovir 1.5 g once daily; P =.35) and
zero for placebo.
Fifty
percent of patients receiving famciclovir 500 mg 3 times daily (P
=.07) and 43% receiving 1.5 g once daily (P =.41) experienced >/=2
points improvement in HAI versus 37% for placebo.
Nine
percent of patients treated with famciclovir 500 mg 3 times daily
underwent anti-HBeAg
seroconversion with undetectable HBV DNA at end of follow-up
versus 3% in the placebo group (P =.05).
Famciclovir
was well tolerated; the incidence of post-treatment alanine
transaminase (ALT) elevations was comparable with placebo.
The
authors conclude, “In conclusion, famciclovir 500 mg 3 times daily
gave modest suppression of viral replication, but translated into
significant histologic improvement in median HAI score at 1 year.”
University
Hospital Rotterdam, Rotterdam, The Netherlands.
02/18/05
Reference
R
A de Man and others. A randomized, placebo-controlled study to evaluate
the efficacy of 12-month famciclovir treatment in patients with
chronic hepatitis B e antigen-positive hepatitis B. Hepatology 32(2): 413-417. August 2000.
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