Miami Herald - Thursday, May 29, 2003
Fred Tasker, ftasker@herald.com

The Food and Drug Administration already has approved immediate nationwide use of the drug; the European Commission followed suit on Wednesday. Both government agencies expedited the drug's approval, even though the studies were not finished.

But a complex manufacturing process means the drug won't be widely available, and it will be expensive.

"This is very important," says Dr. Corklin R. Steinhart, medical director of the Florida AIDS Education Training Center in Miami. Six of his patients participated in the drug trials. "This is the first drug to be specifically approved for people who have run through the usual HIV medications, and who don't have a lot of other options to help keep the virus under control."

Up to 900,000 people are living with HIV in the United States, with another 40,000 HIV infections reported each year, according to the Centers for Disease Control and Prevention.

The new drug, medical name enfuvirtide, is trademarked as Fuzeon by Roche and Trimeris Inc., the partnership that developed it.

It has two major drawbacks. First, its manufacturing process takes 106 steps compared with six or eight for other anti-HIV drugs. Roche spokeswoman Heather Van Ness says only about 15,000 doses can be made this year, and only about 39,000 doses a year even by 2005.

Second, it costs up to $20,000 a year, and must be taken in addition to older anti-HIV drugs, which cost $10,000 to $12,000 a year, Steinhart says.

The new drug is needed most by patients who have developed resistance to existing anti-HIV drugs and whose immune systems are badly damaged. But it works most effectively in patients who can take it in addition to the other drugs, and whose immune systems are more intact.

The drug, approved by the FDA in March, probably will be covered by private health insurance plans, said Susan Pisano, spokeswoman for the American Association of Health Plans.

"What I'm hearing suggests that the real question won't be coverage by private insurers," said Pisano, whose group represents plans that cover 170 million Americans. "It will be availability."

Enfuvirtide is the first of a new class of drugs called entry inhibitors, which fight HIV by interfering with the virus' attempts to enter healthy cells. It's important because as HIV continues to mutate, patients have developed resistance to older drugs.

The results came from two concurrent 24-week studies. One involved 504 subjects at 112 sites in Europe and Australia; the other 501 subjects in North and South America.

"In both studies, when Fuzeon was added to the best available combination of conventional anti-HIV drugs . . . those who received Fuzeon were twice as likely to achieve undetectable levels of the virus than those who took combination therapy without it," said Dr. Jacob P. Lalezari, one of the study's authors.

But enfuvirtide must be given in twice-daily injections, not in pills, making it more complicated, says Margaret Fischl, a University of Miami AIDS researcher. And most patients in studies suffered local injection reactions.

Still, she was encouraged: "It really opens up the possibility of other drugs like it that are cheaper and better, and hopefully can be taken orally."

030529
MH030505

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2003. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .