DURBAN, South Africa, July 11 /PRNewswire/ -- Agouron Pharmaceuticals,
Inc. today reported that, in a long-term study, a majority of people living
with HIV who received VIRACEPT(R) (nelfinavir mesylate) combination therapy
for three years in this clinical trial were shown to experience suppression of
virus as well as replenishment of CD4 cells (a type of immune cell important
in HIV infection). Results will be presented this week at the 13th
International AIDS Conference in Durban, South Africa.
In this multicenter observational study, chief investigator Joseph Gathe,
MD, of the Montrose Clinic (Houston, Texas), reported on 56 HIV-infected
individuals who had never previously taken any anti-HIV drugs who received
VIRACEPT 750 mg three times daily (TID) in combination with standard doses of
zidovudine and lamivudine. At the start of the study, individuals had a mean
plasma HIV RNA of 204,000 copies/mL and a mean CD4 cell count of
310 cells/mm3. After three years, 76.9% (43/56) of participants had plasma
HIV RNA reduced to <50 copies/mL by an ultrasensitive assay, and exhibited an
increase to a mean of 556 CD4 cells/mm3.
VIRACEPT in combination with other antiretroviral agents is indicated for
the treatment of HIV infection.
VIRACEPT 1250 mg (five 250 mg tablets) BID demonstrated a safety profile
similar to that of VIRACEPT 750 mg TID, with the majority of adverse events of
mild intensity. In study 542, diarrhea of moderate or severe intensity was
the most frequently reported adverse event, occurring in 15% to 20% of
patients receiving VIRACEPT 1250 mg BID or 750 mg TID with stavudine or
lamivudine. When diarrhea occurred, it was generally managed with
nonprescription antidiarrheals.
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.
VIRACEPT may interact with some drugs, therefore, patients should be advised
to report to their doctor the use of any other prescription, non prescription
or herbal products, particularly St. John's Wort. Exercise caution when
coadministering with drugs that induce CYP3A or potentially toxic drugs that
are themselves metabolized by CYP3A. Particular caution should be used when
prescribing sildenafil in patients receiving protease inhibitors, including
VIRACEPT.
For further information about Agouron Pharmaceuticals, Inc., or about
VIRACEPT, please see Agouron's website at http://www.agouron.com, or 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. and Pfizer Global Research and Development
La Jolla Laboratories, wholly owned entities of Pfizer Inc. (NYSE: PFE), are
committed to the discovery, development, and marketing of innovative
therapeutic products engineered to inactivate proteins that play key roles in
cancer, AIDS, and other serious diseases. The combined organizations employ
more than 1400 people of whom approximately 850 are engaged in research and
development.
Pfizer Inc, the world's largest pharmaceutical company, discovers,
develops, manufactures and markets leading prescription medicines, for humans
and animals, and many of the world's best known over-the-counter brands. This
year, Pfizer expects global sales of more than $31 billion and has a research
and development budget of $4.7 billion.
WIRES: Full prescribing information for VIRACEPT to follow.
VIRACEPT(R) and Agouron(R) are registered trademarks of Agouron
Pharmaceuticals, Inc.
SOURCE Agouron Pharmaceuticals, Inc.
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Related links:
http://www.agouron.com
Company News On-Call:
http://www.prnewswire.com/comp/019650.html or fax,
800-758-5804, ext. 019650
CONTACT:
Joy Schmitt, United States, 858-622-3220, or
Michael Fagan, Durban, South Africa, 44 77 14 50 38 25, both of
Agouron Pharmaceuticals, Inc.
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