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The outlook for HIV meds: a whole new class of anti-HIV drugs is on the horizon, but some patients are running out of time.

For Jeff Getty, 45, lime is of the essence. The Joshua Tree, Calif., man was diagnosed with HIV 20 years ago and has tried every drug combination available since. But in his case, the virus eventually has become resistant to new treatment mad his medication has become useless.

Four new medications debuted in 2003, but for 2004 only one--a protease inhibitor called tipranavir--is expected to hit the market for so-called treatment-experienced patients like Getty. And while researchers are on the verge of developing a whole new class of anti-HIV drugs, actual production is years away.

"2004 is going to be a dry year," says Steven Miles, associate professor of medicine and director of the University of California Los Angeles, Men's Health Program. "With the exception of tipranavir, nothing will happen, and that is a real problem for these guys who need drugs on an ongoing basis."

Since the advent of HIV, it has been common for the development of new drugs to plateau temporarily, but that's little comfort to Getty. "I am at the end of my rope," says the former HIV/AIDS activist for ACT UP and other groups. His viral load recently reached 100,000 but is now at 40,000, and he says he has between 25 and 50 T cells left. (Healthy people rove at least 500-800 T cells, which help to fight infection.) "I have an opportunistic infection called mycobacterium avium complex that is slowly killing me, and I don't have any new AIDS drugs with any efficacy."

The four new anti-HIV drugs that came out in 2003 are Fuzeon, part of a new class of drugs called entry inhibitors or fusion inhibitors; the protease inhibitors Reyataz and Lexiva; and the reverse transcriptase inhibitor Emtriva.

"We have plenty to treat naive patients who don't have resistance to HIV medications," says Tony Mills, an assistant clinical professor of medicine at UCLA who has a private HIV practice in West Hollywood, Calif., and who is HIV-positive himself. "There are plenty of excellent medications with good penetration and durability."

The greatest excitement for people who have become resistant to treatment seems to surround Fuzeon, the trade name for enfuviritide (T-20), developed by Hoffmann-La Roche and Trimeris. Fuzeon is part of a new class of drugs called entry inhibitors, which attack the way HIV binds with and penetrates T cells. Entry inhibitors bind either to the surface of the T cell or to the virus itself. In either case, they block the virus from attaching to the T cell.

Fuzeon, however, is costly--about $20,000 a year, more than twice as expensive as the entire cost of the typical three-drug cocktail--and it must be taken in twice-daily injections that some experts say leave uncomfortable red welts. Further, it must be used in combination with some other anti-HIV medication, or resistance can develop quickly.

While researchers are still developing a host of other entry inhibitors, no one believes they will debut any time soon. "A number of drugs that are early entry inhibitors are in the pipeline, but you have to think about 2008 for those," says Bob Huff, editor of "GMHC Treatment Issues," an AIDS treatment and research monthly newsletter based in New York City. "You never know if they will make it through."

Meanwhile, a number of factors seem to slow the development of new drugs, including the fact that political pressure from advocates to release more drugs quickly has weakened, due to a combination of "AIDS fatigue" and a decreasing number of AIDS activists.

"There was a period in the mid '90s when protease inhibitors were being developed, and they got through so fast--the first human trials and [Food and Drug Administration] approval were two to three years," says David Gilden, former director of treatment information for the American Foundation for AIDS Research. "There was a real push, and it was considered an emergency situation, and there were large expanded access programs. There is much less political pressure now."

Huff says some doctors are reevaluating theories on managing drug resistance. One philosophy, called "salvage therapy," holds that patients are better off staying on medications that don't seem to be working, because they may weaken the resistant strain of virus.

For some people with AIDS, like Matt Sharp, director of treatment education for Test Positive Aware Network in Chicago, experimental programs have proven lifesaving. Diagnosed with HIV in 1988, the 47-year-old Sharp's immune system is resistant to the older medicines. However, he is on twice-daily shots of Fuzeon, and he is also taking tipranavir in a clinical trial. The combination is working. "I have been able to get my virus to undetectable levels, and that is phenomenal after all these years," he says.

"We are not in as desperate a time as we once were, though everyone could use easier and less toxic drugs to take," he adds. "It will be a matter of the next couple of years and we will have even better and safer, less toxic drugs. We have always had to wait for the better drugs to come along, and we will have to wait some more."
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Title Annotation:Health; tipranavir
Author:Ouittner, Jeremy
Publication:The Advocate (The national gay & lesbian newsmagazine)
Geographic Code:1USA
Date:Mar 16, 2004
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