Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
The Associated Press - 7 Dec 1995
Hoffman-La Roche's saquinavir is the nation's first protease inhibitor, a new class of drugs that cripples an enzyme vital to the late stages of reproduction by the HIV virus.
All other AIDS drugs sold today are nucleoside analogs, which work on another part of the virus. Saquinavir's approval -- in a record 97 days after Roche filed its application -- means doctors for the first time can attack HIV in two separate places.
"This is some of the most hopeful news in years for people living with AIDS," said Health and Human Services Secretary Donna Shalala.
But saquinavir must be taken in combination with older AIDS drugs -- not alone -- for it to work, the FDA emphasized.
Studies show patients who take saquinavir alone get about the same boost in their immune system as those who take AZT, the standard therapy, but not the same drop in the amount of virus in their blood that other AIDS drugs offer.
But patients who took saquinavir together with AZT showed more improvement, seeing a modest boost in their level of vital immune cells called CD4s and about an 85 percent drop in the amount of HIV in their blood. While Roche said 25 percent of patients in one study had a 100 CD4 cell boost after four months of treatment, the FDA cautioned that most patients have just a 30-to-40-cell improvement.
The best results come when patients take saquinavir together with a nucleoside analog they have never before taken, the FDA said.
Patients must take at least 600 milligrams of saquinavir three times a day. The FDA said side effects were generally modest.
Protease inhibitors block an enzyme called protease that is vital to the final stages of HIV's replication. Three companies are developing the drugs, but Roche beat the competition to the FDA -- and the agency found saquinavir so promising that it approved it in 97 days, faster than it has approved any other AIDS drug.
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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