Here is a press release from today for BioChem with factual info re Hepatitis B. Sounds pretty serious to me.
Bee Bop Burke
APRIL 10, 1997
BioChem Pharma - Phase III Clinical Data on Lamivudine
for the Treatment of Hepatitis B
LONDON, UNITED KINGDOM AND LAVAL, QUEBEC--Glaxo Wellcome plc and
BioChem Pharma Inc. announce that results from a Phase III
clinical study of the investigational drug, lamivudine, in
hepatitis B will be presented today in London, U.K., at the annual
meeting of the European Association for the Study of the Liver.
The study, involving 358 Asian patients with chronic hepatitis B
across centres in Hong Kong, Singapore and Taiwan, demonstrates
the significant efficacy of lamivudine in improving liver
histology compared to placebo.
Lamivudine is a nucleoside analogue antiviral drug for the
treatment of hepatitis B, which is under development by Glaxo
Wellcome. The company intends to file for regulatory approval of
lamivudine worldwide beginning with filings in Asia later this
year. The final results of this study will form part of these
applications.
This study was designed primarily to assess the long-term effect
of lamivudine on improving liver histology, an important indicator
of severity and stage of liver disease caused by the body's immune
response against liver cells infected with hepatitis B.
These results indicate that over a one year period, improvements
in liver histology were demonstrated in a significantly higher
percentage of lamivudine patients compared to placebo (67 percent
of patients receiving lamivudine 100 mg orally once daily and 59
percent of patients receiving lamivudine 25 mg orally once daily,
compared to 30 percent of patients receiving placebo). In
addition, fewer lamivudine patients (7 percent of patients on 100
mg and 10 percent of patients on 25 mg) had deterioration of liver
histology compared to placebo (32 percent).
Chronic hepatitis B can cause deteriorating liver histology,
leading to cirrhosis (severe liver scarring) and liver cancer.
Such clinical conditions are due to progressive liver damage. The
most important goal of hepatitis B therapy is to reduce liver
damage caused by the immune system. An antiviral, such as
lamivudine, which reduces viral replication, can reduce the level
of immunological activity against infected liver cells and may
prevent long-term complications associated with this disease. |
