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Being Alive
Expanded Access For Agouron's Protease Inhibitor Viracept Expanded Access Program 800.621.7111

October 5, 1996
Being Alive 1996 Oct 5: 6

Agouron Pharmaceuticals has announced the availability of its new and not-yet-FDA-approved protease inhibitor nelfinavir (brand name Viracept). They have set up an expanded access program for people with advanced hiv disease who have exhausted all current protease inhibitor treatment options.

Nelfinavir will be the fourth protease inhibitor to hit the market in the U.S. Advanced word on this drug is very positive, suggesting that nelfinavir will be at least as effective as the currently available crop of protease inhibitors (and perhaps even more so).

In order to qualify for the expanded access program, an individual must have less than 50 T-cells and be unable to use any of the three approved hiv protease inhibitors-saquinavir (Invirase), ritonavir (Norvir) and indinavir (Crixivan)-because of intolerance, contraindication or prior failure. (In other words, one must have tried all three of the protease inhibitors and stopped, either because of side effects, negative drug interactions or the inability of the drug to lower viral load or raise T-cells.) Phase II/III clinical studies of Viracept are ongoing. Its safety has been established. The most commonly reported side effects are mild to moderate diarrhea, headache and fatigue. An individual interested in obtaining nelfinavir through the Viracept Expanded Access Program must have his/her physician contact Agouron and make a formal application. A toll-free number-800.621.7111-is available for inquiries and information about the Program. Phones will be answered Monday through Friday from 8am-6pm eastern time. Calls placed before or after these hours will be returned during business hours.

Agouron expects to file a New Drug Application with the FDA in the first quarter of 1997 (followed by equivalent regulatory submissions in Canada and Europe). Once it is FDA-approved, nelfinavir's importance in the arsenal of anti-hiv drugs could prove to be crucial. As Dr. Tom Baholyodin wrote in these pages last month, studies have shown that even when hiv develops resistance to nelfinavir, the virus remains susceptible to indinavir (Crixivan), ritonavir (Norvir) and saquinavir (Invirase), as well as a new highly potent protease inhibitor being developed by Glaxo (VX-478), thus making nelfinavir the most logical choice as a first line protease inhibitor. This may not seem like welcome news to those of us already highly experienced in all three protease inhibitors, but for someone who is newly diagnosed or who has recently converted, nelfinavir could provide yet one more powerful drug to use against the virus and stave off the onset of disease.