Reuters Health Information (2005-03-10): Entecavir effective against hepatitis B
Entecavir effective against hepatitis B
Last Updated: 2005-03-10 16:05:29 -0400 (Reuters Health)
WASHINGTON (Reuters) - Bristol-Myers Squibb Co.'s.
experimental drug entecavir is effective for the treatment of chronic
hepatitis B infection, but Food and Drug Administration reviewers also
expressed concern over possible long-term resistance to the drug and
The FDA released documents on Thursday, ahead of a panel meeting
with outside experts on Friday to discuss whether the drug should be
approved. The agency usually, but not always, takes its panelists'
Clinical trials and related studies showed entecavir "effectively reduces the (hepatitis B) viral burden," the reviewers said.
Studies also showed a number of other benefits in patients taking
the drug for 48 weeks, including few major interactions with other
drugs and easily adjusted doses, they said.
But reviewers also expressed caution. "These positive
findings...must be weighed against findings that are less clearly
The effect of the drug beyond 48 weeks is not clear, they said,
warning that there may be a possibility of resistance. "This may have a
significant impact on long-term dosing as the clinical trials
continue," they said.
The company's studies also left lingering questions over whether the
medicine could cause cancer, the reviewers said. They called for the
experts to discuss the risk on Friday.
"To our knowledge, there has not been a public discussion of an
acceptable level of carcinogenicity risk in relationship to chronic HBV
treatment," the reviewers wrote.
Novartis and Idenix Pharmaceuticals Inc. are jointly developing a rival hepatitis drug called telbivudine.