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Adefovir Expanded Access Enrollment Cited By Gilead To Support Approval

Executive Summary

Gilead's adefovir dipivoxil is currently being used by physicians responsible for 70% of the prescriptions for AIDS antiretroviral therapies in the U.S., via the company's expanded access program.

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An "Evolving" Standard for AIDS Drugs?

Antiviral Drugs Advisory Committee member John Hamilton, MD, suggested that advances in AIDS therapy have changed the equation for evaluating new agents. Here are his comments, as transcribed by "The Pink Sheet."

Gilead Adefovir Approval Awaits "Unequivocal" Evidence Of Efficacy At 60 mg

Gilead has begun enrollment in two placebo-controlled trials of a 60 mg dose of adefovir dipivoxil that could provide sufficient evidence to prompt a reconsideration of the HIV therapy by FDA's Antiviral Drugs Advisory Committee.

Bristol-Myers Squibb Videx

Once-daily oral dose of two 200 mg didanosine chewable tablets approved by FDA Oct. 28. Videx' revised label also includes risk information about pancreatitis in patients receiving triple combination therapy including Videx, Bristol's Zerit (stavudine) and a protease inhibitor. Labeling has also added a precaution that "pancreatitis resulting in death was observed in one patient who received Videx plus stavudine plus nelfinavir [Warner-Lambert's Viracept]...and in one patient who received Videx plus stavudine plus indinavir [Merck's Crixivan]." Two of 68 patients receiving Videx/Zerit/Crixivan and Bristol's Droxil (hydroxyurea) died from pancreatitis, labeling continues

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