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Adefovir Dipivoxil Produces sustained improvement in HBV over Long-Term; Presented at HEP DART
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By Bonnie Darves
KOHALA COAST, HAWAII -- December 29, 2005 -- Patients with chronic hepatitis B (HBV) who continue taking adefovir dipivoxil (ADV) for up to 5 years continue to see improvements in hepatic fibrosis, HBV DNA suppression and alanine aminotransferase (ALT) levels, with few adverse effects.
The new data on ADV were presented here at the Frontiers in Drug Development for Viral Hepatitis HEP DART 2005 meeting.
"At 5 years the durability of this [therapy] is still greater than 91%, and efficacy increased over time in all patient populations and disease stages," said presenter Carol Brosgart, MD, Vice President of Public Health and Policy for the drug's maker, Gilead Sciences, Foster City, California, United States.
In his presentation, Dr. Brosgart discussed long-term data on ADV, the first of a new class of nucleotide analogues of adenosine monophosphate.
The study evaluated the drug in two primary groups of patients. The first group included 123 treatment-naive chronic HBV patients with compensated liver function, and the second comprised three cohorts of nearly 500 lamivudine-resistant HBV patients -- those who were wait-listed for liver transplantation, post-transplant patients, and those with HIV co-infection.
Efficacy at 5 years was similar across all groups, Dr. Brosgart noted, with approximately 70% achieving increasingly improved fibrosis as measured by a reduction of 1 point or greater on the Ishak Fibrosis scale. ALT normalization occurred in 69% of the treatment-naive patients at 5 years and 67%.
In HBV/HIV coinfected patients, ALT normalization occurred in 84% at 5 years, and the median log-10 reduction in serum HBV DNA was 6.4, Dr. Brosgart noted. "The magnitude of those reductions continued to increase with treatment duration," she said.
The drug was well tolerated in all patient groups. Less than 3% of patients developed confirmed serum creatinine increases of 0.5 mg/dL over baseline. No ADV mutations were seen and virologic breakthrough occurred in one patient.
"We now have nearly 400,000 patient years of [ADV] treatment data to date, and it is clear that it is well tolerated, with no [tolerability] change with extended dosing," she said, adding that ADV's activity can be enhanced over time.
She cited convenient dosing schedules, a single daily 10 mg dose that does not require timing with food intake, as an additional advantage of the drug over earlier HBV therapies.
[Presentation title: Significant and Sustained Clinical Improvement following Long Term Treatment with Adefovir Dipivoxil: Results after 5 Years of Therapy. Abstract 94]
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