Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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The Wall Street Journal - September 16, 1996
Rhonda L. Rundle, Staff Reporter of The Wall Street Journal
Viracept is a member of a family of protease-inhibitor drugs that, when used in combination with some older drugs, can make the virus undetectable in the blood of some patients. Viracept will be offered to people who have stopped using the three commercially available protease inhibitors because of adverse reactions, intolerable side effects or, in a very small number of cases, because the other drugs appear to be losing their fight against the human immunodeficiency virus.
Peter Johnson, president and chief executive officer of the San Diego drug company, estimated that "somewhere between several hundred to probably several thousand patients" will be candidates to receive Viracept free of charge. The program will be unveiled in New Orleans at the Conference on Antimicrobial Agents and Chemotherapy.
The drug hasn't yet been approved by the U.S. Food and Drug Administration but will be given away with the FDA's approval under an "expanded-access" program. The program ends once the drug is approved for sale, but Agouron says patients in the program won't be cut off if they don't have insurance or funds to pay for the drug.
Agouron is following in the footsteps of Hoffmann-La Roche Inc., Merck & Co., and Abbott Laboratories Inc., which all set up expanded-access programs to give their respective protease inhibitors to certain patients before the drugs received FDA approval. But Viracept and several other emerging protease inhibitors are being tested in a new era when rival drugs are already on the market.
"Agouron has to answer a whole new set of questions, because it is the first of an entire second generation of up and coming compounds," said Dawn Averitt, executive director of the Women's Information Service and Exchange, an Atlanta-based AIDS-treatment group. The people who are waiting for Viracept have tried the other drugs and can't take them or are starting to see their virus levels climb, she said.
Agouron expects to file its Viracept application with the FDA early next year, and activists hope the agency will move quickly to approve the drug. The company has talked to other drug companies, including Bristol-Myers Squibb Co., about a possible marketing partnership. But Mr. Johnson said, "it is now quite unlikely that we would have a partner involved for the U.S. launch." However, "we expect to have one or more partners" in the European market, he added. Viracept would be Agouron's first commercial product.
Viracept has been overshadowed by the three protease inhibitors launched in December and early this year. The giveaway program will draw attention to Viracept, increase doctors' familiarity with it, and identify patients who have been unsuccessful in using the other protease inhibitors. Mr. Johnson said these considerations were "secondary" to the aim of responding to patients' needs.
Agouron initially will limit eligibility to patients with very weak immune systems as measured by CD4 white-cell counts of 50 or less. The drug will be distributed starting Oct. 1 on a first-come, first-serve basis. Agouron said it can treat at least 500 people at first and will scale up as needed. Patients and doctors seeking information about the program can call 1-800-621-7111.
In clinical tests of more than 600 people so far, Viracept has proven to be at least as potent against the virus as the approved drugs, Mr. Johnson said. The only side effect appears to be mild to moderate diarrhea.
"People like it, they don't feel bad on it, and it seems to have good [antiviral] activity," said Robert Schooley, head of the infectious-disease division at the University of Colorado.
A burning question facing Viracept is whether it will work in HIV-infected patients whose virus has mutated in ways that resist the approved protease inhibitors. Activists and physicians report that some patients have "failed" all three drugs, although scientific proof is rare. Mr. Johnson said he believes there are "very, very few" people in that situation.
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