12:00 AM
Aug 12, 2002
 |  BioCentury  |  Product Development

Hints of a higher bar in HBV

Adefovir dipivoxil from Gilead Sciences Inc. sailed through last week's Antiviral Drugs Advisory Committee meeting, with the panel unanimously recommending approval to treat chronic hepatitis B (CHB) in adults with active liver disease based on histological data. At the same time, the committee voiced concerns about using adefovir in patients with renal impairment and in patients co-infected with HIV. And importantly for other companies developing HBV treatments, FDA's analysis of the data imply that the agency might yet again raise the bar for approving new HBV drugs.

A new standard

The advisory panel spent little time worrying over the primary data. To a person, the committee expressed no hesitation in signing off on the use of Adefovir to treat CHB patients with compensated liver disease based on the strength of liver histology data.

The primary endpoint of the two pivotal studies, one in hepatitis E antigen (HBeAg) positive patients and one in HBeAg-negative patients, was a ³2point reduction on the Knodell necroinflammatory score with no worsening in fibrosis score at 48 weeks. Both trials enrolled only patients with compensated liver disease, in which the organ is able to offset the effects of infection.

In the intent to treat populations, 53% of HBeAg-positive and 64% of HBeAg-negative patients had improved liver histology compared to 25% and 33% of patients on placebo (p<0.001 for both trials).

Perhaps more telling, however, was FDA's review of the data, which also focused on fibrosis scores. Using...

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