DURBAN, South Africa, July 13 /PRNewswire/ -- Agouron Pharmaceuticals,
Inc. today reported no difference in adherence to therapy among a survey of
people living with HIV that was designed to compare adherence rates between
either the HIV protease inhibitor VIRACEPT(R) (nelfinavir mesylate) twice
daily (BID) or non-nucleoside reverse transcriptase inhibitors (NNRTIs) given
once or twice daily, each given as part of combination therapy. The study was
conducted by the Adult AIDS Clinical Trials Group (AACTG). Results will be
presented this week at the 13th International AIDS Conference in Durban, South
Africa.
In this prospective multicenter anonymous survey, 136 adults receiving
either VIRACEPT BID (43) or NNRTIs (93; 45 efavirenz and 48 nevirapine) as
part of combination therapy were surveyed for adherence to therapy. Groups
were comparable in demographics, HIV status, and substance abuse history.
Patients surveyed reported the following: missed at least one day of all
doses, VIRACEPT 5%, NNRTI 4%; missed doses in preceding weekend, VIRACEPT 7%,
NNRTI 9%; never missed doses, VIRACEPT 33%, NNRTI 29%; last missed doses
within preceding month, VIRACEPT 37%, NNRTI 38%; last missed doses more than
one month ago, VIRACEPT 30%, NNRTI 33%.
The Adult AIDS Clinical Trials Group (AACTG) is a multicenter cooperative
clinical trials group funded by the Division of AIDS, National Institute of
Allergy and Infectious Diseases of the National Institutes of Health. It is
involved in various phases of clinical research, from early safety studies to
large-scale efficacy trials. The AACTG evaluates new drugs and drug
combinations for the treatment of HIV infection in adults.
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 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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