AEGiS-AP: MEDICINE: Hope Seen in New AIDS Drugs; Called protease inhibitors, these medications act on a different part of the human immunodeficiency viruses life cycle.

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

MEDICINE: Hope Seen in New AIDS Drugs; Called protease inhibitors, these medications act on a different part of the human immunodeficiency viruses life cycle.

Associated Press - 5 November 1995
Lauran Neergaard, Associated Press Staff Writer

WASHINGTON-A long-anticipated new generation of AIDS drugs called protease inhibitors promises the most powerful medicine yet to stall--but not cure--the deadly virus, the nation's top drug regulator says.

The remarks by FDA Commissioner David Kessler bode well for the first protease inhibitor, Hoffmann-La Roche's saquina- vir, which this week undergoes scrutiny by Kessler's top advisers as they decide whether the drug should be sold.

Although he wouldn't discuss saquinavir specifically Kessler said: "There is no question this is the most active class of agents we've seen so far against the AIDS virus."

The key is that protease inhibitors act on a different part of the human immunodeficiency virus's life cycle than currently available drugs. The future in AIDS therapy, Kessler said, may be combining the two types of drugs "for a one-two punch."

"The real breakthrough here will come from combination therapy," he predicted.

Indeed, the Food and Drug Administration's scientific advisers may essentially sound a death knell for single-drug therapy as they consider whether saquinavir and an unrelated but strong antiviral, called 3TC, boost the potency of standard treatment for acquired immune deficiency syndrome.

The panel will decide Monday whether 3TC should be sold as a combination therapy with the older drug AZT, and Tuesday whether saquinavir should get the same approval.

The drugs offer the potential to treat "AIDS and HIV as a chronic condition instead of a deadly disease," said Omar Perez, health director of the National Association of People With AIDS.

Currently, there are just four anti-HIV drugs: AZT, ddI, ddC and d4T. Called nucleoside analogs, they work by blocking a protein active in the early reproduction cycle of the virus, but the virus quickly develops resistance to their effect.

Protease inhibitors block an enzyme called protease that is vital to the final stages of HIV's replication. Three companies are developing the new drugs, but Roche beat the competition to the FDA-and the agency found saquinavir so promising that it rushed the matter to the advisory committee just two months after Roche applied.

Studies show saquinavir in combination with AZT boosts the amount of patients' vital immune cells, called CD4s, by an average of 70 cells per milliliter of blood, said Roche's chief scientist, Dr. Keith Bragman.

Also, HIV may not develop resistance to saquinavir as quickly, he said.

The drug 3TC is another nucleoside analog. When taken together with AZT, it, too, boosted CD4 levels by up to 70 cells, dropped patients' virus content 50 percent to 90 percent and had few side effects, according to manufacturer Glaxo Wellcome Inc.

Glaxo also found that 3TC worked just as well in children with AIDS, and will ask the FDA Monday to approve special strawberry-banana flavored drops for them.

But there are questions about these drugs--particularly, who should take them and when, and do they actually postpone death.

Nobody knows that yet because the FDA allows drugs for fatal diseases to be approved on the basis of quicker studies that track symptoms, not death, and no one has yet directly compared all the varying treatments.

Copyright 1995/The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.

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