THE VIRGINIAN-PILOT
Copyright (c) 1995, Landmark Communications, Inc.
DATE: Friday, December 8, 1995 TAG: 9512080533
SECTION: FRONT PAGE: A4 EDITION: FINAL
SOURCE: ASSOCIATED PRESS
DATELINE: WASHINGTON LENGTH: Medium: 66 lines
AIDS patients will be able to buy by Saturday the first of a long-anticipated new generation of AIDS drugs, the most powerful yet to stall but not cure the deadly virus.
The Food and Drug Administration on Thursday approved saquinavir, 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.
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. Early evidence indicates two protease inhibitors being tested by Roche's competitors are more potent than saquinavir. MEMO: Patients may call Roche for saquinavir information at 1-800-526-6367.
ILLUSTRATION: Photo
HOFFMAN-LAROCHE
Saquinavir, the first in a new line of drugs, will hit shelves
Saturday.
KEYWORDS: AIDS TREATMENT DRUGS by CNB