DURBAN, South Africa, July 13 /PRNewswire/ -- Agouron Pharmaceuticals,
Inc. today reported several studies indicating that a majority of people
living with HIV who received VIRACEPT(R) (nelfinavir mesylate) 1250 mg twice
daily (BID) in antiretroviral combination therapy were shown to experience
reductions in plasma HIV RNA (a measure of virus in the blood) and increases
in CD4 cells (a type of immune cell important in HIV infection). In
real-world clinical settings, the simplified, more convenient BID dosing
schedule showed comparable results to 750 mg three times daily (TID dosing).
Results will be presented this week at the 13th International AIDS Conference
in Durban, South Africa.
In a retrospective study at 4 medical centers reported by lead
investigator R.M. Novak, MD, of the University of Chicago, Illinois, the
effect on adherence and treatment response for 90 HIV-infected patients
switching from TID to BID VIRACEPT combination therapy was examined. Of those
studied, 42 had received no antiretroviral medications before taking VIRACEPT
combination therapy, while 48 had prior treatment experience. At the
initiation of VIRACEPT combination therapy, the mean plasma HIV RNA level was
4.36 log10 copies/mL. Fifty percent (50%, 45/90) of patients reported poor
adherence to the TID regimen; 12% (11/90) reported poor adherence after
switching to BID dosing. For TID and BID VIRACEPT dosing, mean plasma HIV RNA
was 2.69 log10 copies/mL vs. 2.38 log10 copies/mL at mean treatment durations
of 37 and 39.8 weeks, respectively. The percentages of people reported to
achieve HIV RNA below 400 copies/mL were 44.4% (40/90) for TID dosing and
70% (63/90) after switching to BID dosing. The mean CD4 count appeared
greater on VIRACEPT BID dosing (465 cells/mm3) than on TID dosing
(366 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 20% and 15% of
patients receiving VIRACEPT 1250 mg BID or 750 mg TID with stavudine or
lamivudine, respectively. 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 of Agouron Pharmaceuticals, Inc.,
858-622-3220 (United States); or Michael Fagan of Chandler Chicco
Agency, 44 77 14 50 38 25 (South Africa)
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