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Expanded Access Available for New Hepatitis B Drug- Adefovir
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Gilead Sciences is now offering adefovir dipivoxil to patients with
lamivudine-resistant chronic HBV infection through an Expanded Access Program
in the United States.
The primary objective of the Expanded Access Program is to provide access to
adefovir dipivoxil 10 mg prior to its commercial availability to adults with
chronic HBV infection who have developed resistance to lamivudine and who
are at risk of disease progression. Similar programs for other countries
around the world are in the planning stages, including Canada, and will be
initiated in the next few months.
Patients enrolled in the Expanded Access Program will receive adefovir
dipivoxil 10 mg via their physician free of charge until the drug has been
approved by the U.S. Food and Drug Administration and is commercially
available, or until the program is terminated by Gilead.
Program entry criteria include:
- Patients must be at least 16 years of age.
- At least 24 cumulative weeks of prior treatment with lamivudine.
- Lamivudine resistance as defined by positive serum HBV DNA greater
than or equal to 106 copies/mL (PCR assay) and ALT greater than or equal to
1.2 X ULN within four weeks of screening despite ongoing treatment with
lamivudine.
- Adequate hematologic and renal function at screening as defined
within the protocol.
- Physicians will be required to evaluate patients at baseline and
after one month on therapy, then every two months thereafter until drug
discontinuation or study termination. Data collection is limited to the
reporting of adverse events and serious adverse events, concomitant
medications and laboratory results of renal function for determination of
the appropriate dosing interval.
- Patients co-infected with HIV, HCV or other viral infections will be
eligible provided they meet all other entry criteria.
Physicians will be directed to a toll free number for registration at
1-800-GILEAD-5 or
1-650-574-3000. If you have any questions regarding the program please
feel free to call.
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