The Associated Press - 7 Dec 1995

The Food and Drug Administration approved saquinavir Thursday, the first protease inhibitor approved anywhere in the world, to be used with older medicines to slow the HIV virus and boost patients' immune systems.

This new class of drugs cripples an enzyme vital to the late stages of HIV's reproduction while older AIDS medicines work at the front end -- meaning doctors finally can deal the virus a one-two punch.

"This is ... perhaps the most important class of drugs in the fight against HIV so far," said FDA Commissioner David Kessler, who approved saquinavir in a record 97 days.

Manufacturer Hoffman-La Roche Inc., of Nutley, N.J., said saquinavir will be on pharmacy shelves nationwide by Saturday. Sold under the brand name Invirase, a year's supply will cost $5,800 wholesale, although Roche could not give a retail price.

Some AIDS activists were outraged at the price and pledged protests to try to lower it. "It is unconscionable," said Martin Delaney of Project Inform, which got the price of the first AIDS drug, AZT, cut from $8,000 to $2,000 several years ago.

But Roche noted that it takes 15 months to make saquinavir. The company started a new program Thursday to push insurers to pay for saquinavir promptly and give it free to the uninsured.

All other AIDS drugs sold today are nucleoside analogs, which block a protein active in the early reproduction cycle of the virus until HIV develops resistance to them. They are: AZT, 3TC, ddI, ddC and d4T.

Protease inhibitors block an enzyme called protease, which is vital to the final stages of HIV replication. Administering the two types of drugs together allows doctors for the first time to attack HIV in two separate places.

Patients who took saquinavir together with AZT had an average 30- to 40-cell boost in their level of vital immune cells, and an 85 percent drop in the HIV in their blood.

Saquinavir does not work when taken alone, the FDA emphasized. For new patients, the combination therapy can be a first-line treatment while more advanced patients should take saquinavir with any nucleoside they have never tried, the FDA said. Saquinavir has fewer side effects than the older drugs.

But saquinavir does have some problems. Only 4 percent is absorbed by the body, something Roche is furiously trying to fix with a better formula. Nobody knows if the 1,800-milligram dose recommended is high enough for best results.

And early evidence indicates two protease inhibitors being tested by Roche's competitors are more potent than saquinavir. If patients develop resistance to saquinavir, they might not benefit from those more powerful drugs, expected to be sold in about a year, said Gary Rose of AIDS Action Council.

"If you've failed everything else and need a therapy, then go ahead and use it right away. But if you've got a little time to wait, that might make sense," advised Project Inform's Delaney.

Maria Ortiz, 39, of New York decided not to wait. Her immune system was almost totally gone when 3TC boosted it by 100 cells, but she's hoping saquinavir will do even more.

"I'm going to pray that it's going to work and I'll have good news," said Ortiz, on her way to take her first saquinavir dose Thursday.

Despite the concerns, AIDS activists hailed the FDA Thursday for the speedy approval. "They're ahead of anyone in the world in the ability to turn these applications around," Delaney said.

Kessler pledged to rapidly review protease inhibitors being tested by Merck & Co. and Abbott Laboratories, as well as the better saquinavir formula that Roche is working on. Merck and Abbott have not yet filed FDA applications, but early data indicate their versions are more potent than saquinavir.

"We know we can do better" than the current saquinavir formula, Kessler said. "When the other proteases get to the market, they will provide a whole new set of tools to fight this deadly virus."

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Patients may call Roche for saquinavir information at 1-800-526-6367.

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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Copyright © 1995 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.

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