- The Washington Times - Friday, August 23, 2002

An experimental AIDS drug, which has won a priority six-month review by the U.S. Food and Drug Administration, could prolong the lives of patients with drug-resistant strains of HIV, provided they can afford it.
The developers of the drug, called Fuzeon or T-20, hope that the medication is approved and on the market by the spring. They point out that Fuzeon is the first in a revolutionary new class of AIDS drugs designed for HIV patients whose viral infections are resistant to other therapies available.
"There are a lot of people who need it. Half of the people under treatment [for HIV] are resistant to at least one drug but Fuzeon is going to break the bank as far as some government drug programs are concerned," David Gilden, spokesman for the New York-based American Foundation for AIDS Research, said in a telephone interview yesterday.
Fuzeon's developers, the Swiss-based Roche Group and Trimeris Inc. of Durham, N.C., say the drug is complicated to produce and will be expensive. Some published reports say it could be the single most expensive AIDS drug on the market, costing between $10,000 and $15,000 per patient per year.
Mr. Gilden said the latter figure would be twice the price tag of the most expensive AIDS drug now available.
The FDA has approved 16 different AIDS drugs, he said, and the most expensive are Fortovase, Viracett and Kaletra. Each cost about $7,000 per patient per year. However, total costs of some combination therapies such as Viracett combined with Fidex can run to $11,000 or $12,000 a year, he said.
A Roche official has said it takes 106 chemical steps to manufacture Fuzeon. No more than 10 steps are involved in making other AIDS therapies, he said.
Also, the official said, about 45 tons of raw materials are needed to produce 1 ton of Fuzeon's active ingredients. He stressed that researchers are striving to achieve a better drug yield.
Another drawback, said Mr. Gilden, is that Fuzeon has to be injected. He said other AIDS drugs are "pills that can be popped."
Despite the obstacles, enthusiasm about Fuzeon is high. The drug works by blocking the human immunodeficiency virus from entering or fusing with a blood cell. Fuzeon is part of a new class of drugs known as peptide fusion inhibitors. In contrast, AIDS treatments now in use work inside the blood cell and target viral enzymes responsible for the spread of HIV.
Data from two large international clinical trials, presented at the XIV International AIDS Conference in Barcelona in July, showed that HIV patients on combination therapy with Fuzeon were twice as likely to have undetectable levels of HIV in their blood as those who did not receive Fuzeon. Fuzeon also provided a "significant increase in immune cells" at 24 weeks, compared with patients who received combination therapy without Fuzeon.
The drug is in the third phase of clinical trials for efficacy and has been given "fast track" designation by the FDA.
Trimeris Inc. and Roche, which has a U.S. facility in Nutley, N.J., have warned of a potential Fuzeon shortage. Roche, which will manufacture the drug, and Trimeris, which will distribute it, have said they will be able to supply only about 3,000 patients when Fuzeon first hits the market.
No one can say how many of the estimated 850,000 to 950,000 Americans infected with HIV are resistant to existing drugs. But Investor's Business Daily has reported the number in the "tens of thousands."
The Fuzeon manufacturing plant in Colorado has been set up to make enough of the AIDS drug for 25,000 patients by the end of 2003 and 40,000 patients by the end of 2004. But officials at Roche and Trimeris believe demand will be greater.
Scott Brawley, director of public policy for AIDS Action, a lobbying group that represents more than 1,400 AIDS service organizations, says he believes it will be difficult for HIV patients in tax-funded health care programs such as Medicaid, Medicare and the Ryan White Care Act's AIDS Drug Assistance program to obtain Fuzeon because of its potential high cost.

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