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New AIDS Drug Will Be Free to Some Patients

HIV* Hundreds in U.S. who have a resistance to existing therapies will be eligible for Fuzeon under the FDA's 'compassionate use' program.

September 16, 2002|LINDA MARSA

An experimental AIDS drug will become available to seriously ill patients free of charge in early October.

The drug, Fuzeon, is the first in a new class of drugs known as fusion inhibitors to be made available under the Food and Drug Administration's "compassionate use" program, which permits certain patients to take a drug before it is approved for sale. Scientists estimate that tens of thousands of the 850,000 to 950,000 Americans infected with HIV have developed resistance to existing drugs.

Fusion inhibitors are "a significant breakthrough" because they thwart HIV at a much earlier stage in the virus' life cycle than current treatments, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in Bethesda, Md. Standard AIDS drugs work inside the cell, foiling HIV by stopping production of one of two key enzymes, protease or reverse transcriptase, that the virus needs to replicate. Fusion inhibitors, in contrast, prevent HIV from entering the cell and inserting its DNA into the patient's genetic machinery.

Two recent studies, involving nearly 1,000 volunteers with high viral counts, used Fuzeon in combination with three to five standard anti-HIV drugs. The therapy reduced viral loads to undetectable levels (below 50 copies per milliliter) in up to 20% of the test subjects for whom current AIDS drug therapies were ineffective.

Fuzeon "proves HIV is vulnerable to an attack directed at an entirely different target," said Fauci, who believes results will improve when the drug is used by HIV patients who aren't as sick. This also paves the way for devising more potent drugs that keep HIV from invading healthy cells, some of which already are in development.

Another advantage of Fuzeon is that it doesn't have serious side effects like other antiretrovirals. However, patients must self-administer the drug twice a day by injection, making it less convenient than AIDS drugs taken in pill form. Also, Fuzeon must be combined with other anti-HIV medicines to be effective. "Patients who are running out of treatment options will probably benefit the most from the drug," said Dr. Peter R. Wolfe, an HIV specialist in Beverly Hills.

The drug has "fast track" approval status from the FDA and may be on the market by spring 2003. However, some experts predict that its cost could exceed $12,000 annually. "We haven't announced the price yet, but we anticipate it will probably be more expensive than existing therapies," says Heather Van Ness, a spokeswoman for Hoffman-La Roche Inc. in Nutley, N.J., which developed Fuzeon in partnership with Trimeris Inc. in Durham, N.C. The most expensive AIDS drugs now cost a little less than $8,000 a year.

Fuzeon will be distributed by doctors enrolled in the compassionate-use program to 1,200 patients worldwide, including 600 in the U.S. To be eligible, patients must be under the care of participating physicians.

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