NEW ORLEANS, Sept. 8 /PRNewswire/ -- Malte Schutz, MD (Illinois Masonic
Medical Center, Chicago, IL) and William Owen, MD (California Pacific Medical
Center, San Francisco, CA) reported a study today which evaluates the
durability of anti-HIV therapy including RESCRIPTOR(R) (delavirdine mesylate)
tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI), as a part
of combination therapy that contains HIV protease inhibitors. As the fight
against HIV continues, the need for therapies to treat people failing previous
therapy has intensified. In data to be presented at the 38th Infectious
Diseases Society of America meeting this week, RESCRIPTOR-containing
combination therapy that was administered for one year or more was shown to
suppress virus in a group of people failing antiretroviral therapy who had not
previously received an NNRTI.
In this observational retrospective study (years 1996-2000), data from two
Chicago and San Francisco urban practices were reviewed for all NNRTI-naive
individuals failing antiretroviral therapy. Data from thirty-two persons who
were then treated with combination therapy containing RESCRIPTOR plus protease
inhibitors are reported. After a mean of 131.4 weeks treatment
(range 56-209 weeks), 59.3% (19/32) of individuals had attained HIV RNA levels
<400 copies/mL, and 43.8% (14/32) were <50 copies/mL. The mean plasma HIV RNA
level was 48,141 copies/mL at study entry. Upon initiation of
RESCRIPTOR-containing therapy, this heavily treatment-experienced group had
been previously exposed to a mean of 5.2 antiretroviral medications comprised
of a range of 2-5 nucleoside reverse transcriptase inhibitors (NRTIs) and
1-4 protease inhibitors (PIs). RESCRIPTOR-containing regimens, administered
after failure of these previous regimens, contained 1-2 PIs and 1-2 NRTIs.
RESCRIPTOR-based combination therapy including PIs showed a similar level of
response irrespective of baseline viral load, CD4 and level of exposure to
previous antiretrovirals.
"People who have failed first or even second-line antiretroviral regimens
are now a greater share of the total HIV-infected population. Identification
of treatment options for these individuals is of critical importance to
sustain our fight against HIV. Consideration can be given to RESCRIPTOR as a
part of potential options for these regimens," said Malte Schutz, MD, a lead
investigator on this study.
RESCRIPTOR tablets are indicated for the treatment of HIV-1 infection in
combination with appropriate antiretroviral agents when therapy is warranted.
This indication is based on surrogate marker changes in clinical studies.
Clinical benefit was not demonstrated for 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 duration of the rash
was less than 2 weeks and did not require dose reduction or discontinuation of
treatment (4.3 percent of patients in clinical trials discontinued due to
rash).
Agouron Pharmaceuticals, Inc., a Pfizer Company (NYSE: PFE), is 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. Agouron employs 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 $30 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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http://www.agouron.com
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http://www.prnewswire.com/comp/019650.html or fax,
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CONTACT:
Joy Schmitt, Director, Product Public
Relations of Agouron Pharmaceuticals, Inc., 858-622-3220
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