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FDA approves new drug to fight HIV

May work when other protease inhibitors don't


April 16, 1999
Web posted at: 5:36 p.m. EDT (2136 GMT)

From Medical Correspondent Al Hinman

WASHINGTON (CNN) -- The U.S. Food and Drug Administration has approved another new drug to help fight HIV. Agenerase, known generically as amprenavir, is the first new protease inhibitor to win federal approval in more than two years.

According to the drug's manufacturer, Glaxo Wellcome Inc., the research used for accelerated FDA approval indicates that Agenerase offers several advantages over other protease inhibitors now available to fight the virus that causes AIDS.

Research involving 1,400 patients showed that Agenerase, taken in combination with other antiviral drugs, significantly reduced the level of HIV during the 24-week study.

Glaxo Wellcome says the research shows Agenerase may work as a new alternative for longer-term HIV patients for whom some or all other protease inhibitors no longer work. That occurs when the virus mutates, making the drugs ineffective.

 Recommended dosage:
Adult: eight capsules twice a day
Children 4 and older: liquid formula

Take with or without food
Never take with high fat meal
(decreases drug absorption)
 Side effects:
Common: nausea, diarrhea, vomiting, rash

Rare: severe and life-threatening skin reactions, including Stevens-Johnson syndrome (less than 1%)

Possible dangerous interactions with other drugs
$6,132.00 per year, wholesale

According to the manufacturer, Agenerase also appears not to have as significant a lipid (blood fat) problem as other protease inhibitors. Patients taking protease inhibitors often experience significant increases in cholesterol and lipid levels, increasing the risk of coronary heart disease.

But an FDA spokesman says it's not yet known how this latest protease inhibitor works over the long term.

Agenerase does offer patients a possible dosing advantage: It's taken only twice a day, as opposed to the normal three-times-a-day dose for most protease inhibitors. Although the manufacturer is advising patients the drug can be taken with or without food, the FDA recommends the drug be taken with food.

There now are six protease inhibitors approved for treating HIV. The class of drugs is credited with helping those infected with the AIDS virus live longer, healthier lives, despite some frequently serious side effects.

Protease inhibitors are recommended to be taken as part of a three-or-more drug "cocktail", and have been shown to help reduce the amount of virus in the body to levels too low to be detected by today's best tests.

Agenerase was developed by drug maker Vertex, but is being manufactured by Glaxo Wellcome, developer of the first HIV-fighting drug, AZT.

The wholesale price for Agenerase will be $16.80 per day, or $6,132.00 annually, according to manufacturer Glaxo Wellcome. Literature from the company states that the price to patients may vary depending on where they get the prescription filled.

Food and Drug Administration
GlaxoWellcome: For information on Agenerase
GlaxoWellcome: For prescribing information
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