updated 4/15/2004 12:42:22 PM ET 2004-04-15T16:42:22

A year after launching the first drug in a new class of AIDS medications, Hoffmann-La Roche Inc. says it has overcome shortages of its hard-to-manufacture Fuzeon and is making it widely available.

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Fuzeon, which costs more than $20,000 a year, will be available starting April 26 at retail and specialty pharmacies nationwide, the Nutley, N.J.-based drug maker said Wednesday. In addition, more state AIDS drug assistance programs are now covering the drug — 37, up from 19 last July. Medicaid and most private insurers already cover it, according to the company.

Unlike other AIDS drugs, Fuzeon blocks the HIV virus, the cause of AIDS, from entering immune cells. But because of the cost and the need for patients to inject it themselves twice a day just under the skin in the thigh, arm or belly, patients normally get Fuzeon only when other AIDS medicines no longer work.

Use limited by cost
Jules Levin, executive director of the National AIDS Treatment Advocacy Project, said Fuzeon’s use has been limited by the cost and doctors’ belief many patients couldn’t handle the injections and the swelling, tenderness and nodules that sometimes develop at injection sites, even though no other side effects are common.

Hoffmann-La Roche initially limited access to ensure patients starting on Fuzeon could keep getting it because missing medication doses makes it easier for the HIV virus to grow resistant to the drugs.

Previously, doctors had to send a special order for Fuzeon to a single specialty pharmacy company, which mailed it back after determining an insurer would pay. Levin said some insurers still make doctors get pre-approval for the prescription, requiring extra paperwork and a second office visit by the patient.

Pamela Van Houton, a spokeswoman for Hoffmann-La Roche, part of the Swiss-based Roche Group, said the company has expanded manufacturing capacity, so doctors now can write a prescription for patients to take to any pharmacy.

Fuzeon’s high cost is due to its complexity, the company says. Production involves 44 different raw materials and more than 100 manufacturing steps and takes about six months.

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