AEGiS-BALA: Viracept Approved By FDA


Viracept Approved By FDA

Being Alive; April 1997
Walt Senterfitt

On March 14, the FDA (U. S. Food and Drug Administration) announced that it had approved the marketing of nelfinavir (Viracept) by its manufacturer, Agouron, Inc. of San Diego. The approval came rapidly under the FDA's accelerated review and approval process for drugs for hiv and other life-threatening conditions. The approval is based solely upon the ability of the drug to reduce viral load and increase CD4 or T-cell counts in clinical trials of 24 weeks. The company must conduct further studies to characterize the durability of response to the drug as well as to show its benefit in terms of slowing progression to symptomatic disease or death.

It is good news for all PWAs and hiv positives to have a fourth protease inhibitor approved for marketing and availability. Agouron announced that the drug would be widely available through retail and mail order pharmacies as well as institutional suppliers within a few days. The company was expecting approval, and had geared up production and distribution capacity with help from its major investor and Viracept's co-sponsor, the Japan Tobacco Company.

Approval for Adults and Children

The approved dose for adults is 750 mg three times a day (slightly less stringent that the every-8-hours regimen that had originally been thought necessary). The company and many advocates for children with aids were proud that it is the first protease inhibitor approved for use in adults and children at the same time.

Viracept promises, on the evidence available so far, to be at least as potent as the other protease inhibitors or combinations now in use and probably safer (fewer dangerous adverse effects) and more tolerable (fewer obnoxious side effects). The major side effect reported in clinical trials was diarrhea, which affected about 20% of the study participants on the 750 mg dosage of Viracept. The company says this diarrhea generally responds well to Immodium.

Adverse Drug Interactions

There are fewer, but still some, adverse drug interactions reported so far with nelfinavir or Viracept. In particular, it is advised that one not take the following drugs while taking Viracept: astemizole (Hismanal), cisapride (Propulsid), rifampin, terfenadine (Seldane) or triazolam (Halcion). There may be others: read the package insert and consult your medical provider. Agouron's representatives say that it should be acceptable to take certain decongestants or antihistamines that have been a problem with other protease inhibitors, including loratidine (Claritin) and fexofenadine (Allegra).

Data on nelfinavir's resistance profile is still incomplete, but preliminary data is encouraging. If one develops resistance to nelfinavir, there does not appear to be cross-resistance to other protease inhibitors. The reverse, however, is still unknown (i.e., if one is resistant to other protease inhibitors, will one be cross-resistant to nelfinavir?). The data are being collected to answer this question. Data is also not yet available on the effect of combining Viracept with other antiviral drugs, including Viramune (nevirapine) and the other protease inhibitors.

Assistance Programs

The wholesale cost will be $15.48 a day or $5650 a year, roughly comparable to the others of the same class. The company has announced a Viracept Assistance Program to help solve cost problems by obtaining reimbursement, or providing free drug to "those whose needs are greatest and who are least able to pay." (This implies a rationing or a priority system of providing free drug, based on severity of need.) For children, Agouron says it will supply the drug without charge to anyone not covered by public or private health insurance. (Note the different standards for adults and kids.) The Assistance Program can be reached toll-free at 888.777.6637.

We will bring you more information on actual usage in the community and additional recommendations, as that information becomes available. In the meantime, Agouron's Consumer Communications number (for questions about side effects, interactions, dosages, etc.) is also toll-free, 888.847.2237. You might also call the Project Inform Hotline or consult your favorite hiv informational Website.


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This information is designed to support, not replace, the relationship that exists between you and your doctor.
©1997. AEGIS.