Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
The Associated Press; 50 Rockefeller Plaza, New York, NY 10020 - Friday, November 7, 1997; 7:28 p.m. EST
Lauran Neergaard, AP Medical Writer
Hoffman-La Roche's Fortovase, the improved version of the protease inhibitor saquinavir, will be on pharmacy shelves the week of Nov. 17. The company said it will cost the same as Invirase, the old brand of saquinavir -- about $5,700 a year wholesale.
Saquinavir was the first of a powerful new class of AIDS drugs called protease inhibitors to hit the market, in December 1995. But at the time, the FDA cautioned that saquinavir was the weakest of these new drugs, and Roche immediately began strengthening it.
The new Fortovase version comes in a soft gelatin capsule that delivers more drug through the body than Invirase, the FDA said.
One study showed that after 16 weeks of treatment, twice as many patients who took Fortovase had undetectable levels of the HIV virus in their blood as did patients who took Invirase, the FDA said.
The reason? The original hard capsule of Invirase took so long to dissolve in the digestive tract that enzymes had a chance to degrade it, leaving less to enter the bloodstream and fight HIV.
The soft formula combines the drug with an oil-like substance that is rapidly digested, so more medicine can get to the bloodstream, Roche said.
The FDA said Fortovase's side effects are similar to those of Invirase, including diarrhea, nausea and abdominal discomfort.
Roche will continue to sell the older Invirase for six months, giving the 40,000 Americans now taking Invirase time to switch to the new formula. The company recommended that patients consult their physicians to determine if and when to switch.
"We're hoping that most people will switch," said Roche's Dr. Sandy Palleja. "There are many patients doing well on the current formulation. ... Those patients would have a more durable effect" on Fortovase.
But Roche pledged to make limited amounts of Invirase available if some doctors decide not to change their patients' medicines.
AIDS experts recommend that most patients take combinations of drugs that generally include one protease inhibitor with two other types of anti-HIV medications. The dosage of Fortovase is 1,200 milligrams taken three times a day with meals.
Copyright 1997/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 © 1997 - 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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