Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
PRNewswire - November 29, 1999
"We are gratified that the FDA has approved twice daily dosing for VIRACEPT," said Peter Johnson, Agouron's president and chief executive officer. "This simpler and more convenient dosing schedule for VIRACEPT, that preserves its safety, tolerability, and anti-HIV potency, will further enhance the utility of the most extensively prescribed HIV protease inhibitor in the United States."
The clearance was based principally on interim results from a pivotal phase III trial involving more than 500 patients that showed similar decreases in plasma HIV RNA and increases in CD4+ T cell counts between 1250mg BID and 750mg TID dosing of VIRACEPT, and a similar safety profile, when used in combination with standard doses of Zerit(R) (d4T or stavudine) and Epivir(R) (3TC or lamivudine).
VIRACEPT is indicated for the treatment of HIV infection when antiretroviral therapy is warranted. This indication is based on analyses of surrogate marker changes in patients who received VIRACEPT in combination with nucleoside analogs or alone for up to 24 weeks. 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 is generally well-tolerated when taken 1250 mg BID or 750 mg TID. In study 542, diarrhea of moderate or greater intensity occurred in 14% to 18% of patients receiving VIRACEPT 1250 mg BID or 750 mg TID with stavudine or lamivudine. New onset or exacerbation of diabetes mellitus and hyperglycemia, changes in the distribution of body fat, and increased bleeding in patients with hemophilia types A and B have been reported with protease inhibitors.
For further information about Agouron Pharmaceuticals, Inc., or about VIRACEPT, please dial toll free 1-888-VIRACEPT (847-2237). To receive full prescribing information for VIRACEPT via fax, dial 1-888-288-9639.
Agouron Pharmaceuticals, Inc., a wholly owned subsidiary of the Warner-Lambert Company (NYSE: WLA), is an integrated pharmaceutical company committed to the discovery, development, manufacturing, and marketing of innovative therapeutic products engineered to inactivate proteins that play key roles in cancer, AIDS, and other serious diseases. Agouron employs more than 1,100 people of whom approximately 700 are engaged in research and development.
VIRACEPT(R) and Agouron(R) are registered trademarks of Agouron Pharmaceuticals, Inc.
Zerit(R) is a registered trademark of Bristol-Myers Squibb Company.
Epivir(R) is a registered trademark of Glaxo Wellcome Oncology/HIV.
SOURCE Agouron Pharmaceuticals, Inc.
CONTACT: Joy Schmitt, Associate Director, Product Public Relations, of Agouron Pharmaceuticals, 858-622-3220/
Web Site: http://www.agouron.com/
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