The recent Food and Drug Administration approval of Fuzeon, the first in a new class of AIDS drugs, shows promise in helping a substantial number of HIV and AIDS sufferers who have developed resistance to many of today's common anti-retroviral drugs.
Fuzeon was discovered in the early 1990s by two Duke researchers who subsequently established Trimeris, a local pharmaceutical firm, to complete the transition from drug discovery to clinical application.
Dani Bolognesi, James B. Duke professor of surgery and chief executive officer of Trimeris, was "overwhelmed" with the approval of the drug.
"The results of the drug beat all expectations - "they were simply spectacular," he said. "No one believed we'd be able to restore the immune system and suppress the viral response or even restore quality of life."
Fuzeon, which inhibits the ability of the HIV virus to fuse to cells of the immune system, signals the wave of the future for AIDS drugs. Both Bolognesi and Dr. Charles Hicks, associate clinical professor of medicine, stressed that new drugs with novel mechanisms of action such as fusion inhibitors are imperative in the continuing struggle against AIDS.
Hicks said that Fuzeon is aimed primarily at patients who have accumulated high resistance to conventional drugs and are experiencing slowly increasing viral counts. He added that patients would first exhaust current treatment options, which include protease and reverse transcriptase inhibitors, before combining them with Fuzeon once resistance has developed.
Only about 6,000 to 8,000 patients will have access to the drug this year, Hicks said. Although 2,000 kilograms are being produced currently, this quantity is not sufficient to accommodate the demand for the drug, and Bolognesi said that plans are in store to double capacity.
Fuzeon has not been received without controversy, however. Although few dispute the promise the drug holds, AIDS advocacy groups such as ACTUP - AIDS Coalition to Unleash Power - are strongly opposed to the high price set by Roche Pharmaceuticals, Trimeris' partner in the manufacturing and distribution of the drug.
Fuzeon will be administered as a twice-daily injection. Because this mechanism is radically different from the common avenue of a pill delivery, its cost will be much steeper than the current AIDS drugs on the market.
With a price of slightly under $20,000 per year, Fuzeon is much more expensive than current treatments, which range in cost between $7,000 to $12,000 per year. However, Bolognesi was quick to point out that Fuzeon is comparably priced to similar biological drugs such as those for cancer.
Mark Milano, a spokesperson for ACTUP, decried the high cost for Fuzeon treatment, saying that setting this price was tantamount to allowing people to die.
"It's price gouging.... We don't feel it's justified by the research and development or manufacturing costs," he said, adding the drug could easily cost only $10,000 per year.
Bolognesi refuted Milano's assertion, stating that Trimeris and Roche were recovering far less than the usual profit margins made on traditional drugs and that Trimeris was instituting two programs to help patients receive reimbursement for Fuzeon or receive the drug free of charge.
Tom Matthews, original discoverer of the drug at Duke and senior vice president of research and development at Trimeris, said he understood the plight of patients for whom Fuzeon is unaffordable.
"We're very sympathetic to [the fact that it's expensive], but it's just an extremely complicated drug," said Matthews, an associate research professor of experimental surgery. However, he added that Trimeris was heavily investing in developing drugs that could be less expensive.
Regardless of Fuzeon's availability, trials have shown its clinical effectiveness. The next step, Bolognesi said, is to improve fusion inhibitors and to develop more powerful forms.
T-1249, the second generation drug which is approximately three years behind Fuzeon, deals with viruses that have developed a resistance to Fuzeon. A third-generation drug in the pipeline will eventually counteract T-1249 resistance.
With fusion inhibitors holding the key to future AIDS treatments, clinicians are anticipating Fuzeon's success in patients.
"Fuzeon will be a new weapon in the arsenal of AIDS drugs," Hicks said.
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