DURBAN, South Africa, July 11 /PRNewswire/ -- Agouron Pharmaceuticals,
Inc. today reported results from studies evaluating safety and efficacy of
RESCRIPTOR(R) (delavirdine mesylate) Tablets, a non-nucleoside reverse
transcriptase inhibitor (NNRTI), as part of combination therapy containing HIV
protease inhibitors (PIs) for the treatment of HIV infection. In data to be
presented this week at the 13th International AIDS Conference in Durban, South
Africa, RESCRIPTOR appeared to enhance HIV protease inhibitor-containing
combination therapy by reducing plasma HIV RNA (a measure of virus in the
blood) and increasing CD4 cells (a type of immune cell) in a small study of
people failing antiretroviral therapy who had never previously received
NNRTIs. In an additional report, combination therapy containing RESCRIPTOR
and a reduced dose of indinavir lowered the rate of nephrolithiasis (kidney
stones) compared to full dose indinavir without RESCRIPTOR.
In a retrospective study conducted at the California Pacific Medical
Center in San Francisco, CA, 13 NNRTI naive HIV-infected individuals in an
urban private practice who were failing antiretroviral treatment received
RESCRIPTOR as part of second-line therapy in combination with either a new
single PI or dual PI regimen. At study entry, the median plasma HIV RNA level
was 25,650 copies/mL, and the CD4 cell count was 176 cells/mm3. After 24
months of treatment, 84% (11/13) of individuals had attained HIV RNA levels
< 500 copies/mL, and the median CD4 cell count was 410 cells/mm3. "NNRTIs as
a class of drugs may have an impact on subsequent therapy. In designing
strategies for antiretroviral therapy, consideration can be given to using
RESCRIPTOR for subsequent regimens," said W.F. Owen, Jr., MD, lead
investigator on this study.
In preliminary studies conducted by Joseph Eron, MD, at the University of
North Carolina, Chapel Hill, the coadministration of RESCRIPTOR with a regimen
including a reduced dose of indinavir was shown to result in an incidence of
nephrolithiasis of 1% (2/199); for patients receiving a regimen including full
dose indinavir without RESCRIPTOR, the incidence was approximately
9.9% (7/71). In two open-label clinical studies a total of 270 HIV-infected
patients were randomized to receive regimens including 400 mg RESCRIPTOR three
times daily (TID) plus a reduced dose of indinavir (600 mg or 400 mg) TID, or
a control regimen including the full dose of indinavir (800 mg) TID without
RESCRIPTOR. In this study, RESCRIPTOR was shown to boost the minimum
concentration of indinavir in the body after administration while minimally
affecting the maximum concentration (peak concentration).
RESCRIPTOR tablets are indicated for the treatment of HIV-1 infection in
combination with appropriate antiretroviral agents when therapy is warranted.
The indication is based on surrogate marker changes in clinical studies.
Clinical benefit has not been demonstrated with RESCRIPTOR based on survival
or incidence of AIDS-defining clinical events in a completed trial comparing
RESCRIPTOR plus didanosine with didanosine monotherapy.
Resistant virus emerges rapidly when RESCRIPTOR is administered as
monotherapy. Therefore, RESCRIPTOR should always be administered in
combination with appropriate antiretroviral therapy.
RESCRIPTOR has been shown to be generally well tolerated. The most
commonly reported side effect attributable to RESCRIPTOR was a skin rash that
occurred in 18 percent of patients. In most cases, the rash disappeared
within three to 14 days without a dosage reduction or interruption of
treatment (4.3 percent of patients in clinical trials discontinued due to
rash).
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.
For further information about Agouron Pharmaceuticals, Inc., or about
RESCRIPTOR, please dial toll free 1-888-847-2237. To receive full prescribing
information for RESCRIPTOR via fax, dial 1-888-288-9639.
Agouron(R) is a registered trademark of Agouron Pharmaceuticals, Inc.
RESCRIPTOR(R) is a registered trademark of Pharmacia & Upjohn.
RESCRIPTOR is distributed by 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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