VIRACEPT (nelfinavir mesylate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved March 1997

Specific Treatments:

HIV infection

General Information

VIRACEPT has been approved for the treatment of HIV infection in adults and children; the drug was approved under provisions of the FDA’s accelerated approval process. VIRACEPT is indicated for the treatment of HIV infection when antiretroviral therapy is warranted.

The Wholesale Acquisition Cost of VIRACEPT will be $15.48 per day or $5650 for a 365-day supply at the recommended dose of 750 mg three times daily (TID). To facilitate patients’ access to VIRACEPT, Agouron has established a patient assistance program to actively help people to find ways of paying for VIRACEPT. Agouron will provide VIRACEPT without charge to those patients whose need is greatest and who are least able to pay for the drug. In addition, Agouron will provide VIRACEPT without charge to any child in the United States who is not covered by public or private health insurance. For information on the VIRACEPT Assistance Program for both adults and children, call toll free 1-888-847-2237.

Clinical Results

At present, there are no results from controlled trials evaluating the effect of therapy with VIRACEPT on clinical progression of HIV infection, such as survival or the incidence of opportunistic infections.

VIRACEPT has been evaluated in clinical trials involving more than 1000 people to date and has been made available without charge to an additional 3000 patients through the VIRACEPT Expanded Access Program. Expanded access programs represent an effort by FDA to make investigational drugs available at the earliest opportunity to people for whom no other comparable or satisfactory therapy exists.

Side Effects

In clinical studies of VIRACEPT, the most commonly observed adverse event of moderate or greater severity was diarrhea which was generally controlled with over-the-counter medications.