DURBAN, South Africa, July 13 /PRNewswire/ -- Agouron Pharmaceuticals,
Inc. today reported a study in healthy volunteers indicating that an
investigational once-daily dosing (QD) of the HIV protease inhibitor
VIRACEPT(R) (nelfinavir mesylate) in combination with small doses of ritonavir
resulted in comparable pharmacokinetics of VIRACEPT relative to twice daily
dosing (BID) of VIRACEPT alone. This study, which also examined tolerability
of the combination, provides a favorable basis for further studies to evaluate
the safety and efficacy of a simplified once-daily dosing of VIRACEPT in
combination with ritonavir. Agouron scientists will present results this week
at the 13th International AIDS Conference in Durban, South Africa.
The combination of ritonavir with other HIV protease inhibitors has been
shown to increase blood levels. In this open-label study, concentrations of
VIRACEPT and its active metabolite M8 were measured in participants over a
period of 24 hours on day 14 of a once-daily dosing regimen. QD dosing of
VIRACEPT plus ritonavir showed comparable AUC(24), C(max), and C(min) values
(standard measures of drug exposure), with respect to a control arm of
VIRACEPT 1250 mg BID without ritonavir, in the following investigational
dosage combinations (10 volunteers per arm): VIRACEPT 1875, 2500, and 2500
mg, with respective ritonavir doses of 200, 100, and 200 mg. The combined
concentrations of VIRACEPT and its active metabolite M8 showed similar or
higher results for all three pharmacokinetic parameters in these groups. No
serious adverse events were observed in this study.
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.
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, 858-622-3220 (United
States); or Michael Fagan of Chandler Chicco Agency, 44 77 14 50
38 25 (South Africa)
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