LA JOLLA, Calif., Feb. 2 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
(Nasdaq: AGPH) today reported plasma HIV RNA levels below the level of
quantification (<500 copies/mL, experimental Chiron bDNA assay) at a median
followup of 60 weeks in a majority of patients who, after failing treatment
with VIRACEPT(R) (nelfinavir mesylate) in combination therapy, were treated
with other protease inhibitors in combination therapy. Results will be
presented by investigators this week at the 6th Conference on Retroviruses and
Opportunistic Infections in Chicago, Illinois.
Pablo Tebas, M.D., from Washington University in St. Louis, MO, reported
an evaluation of 24 patients who had failed (defined as two consecutive
measurements of >5000 copies HIV RNA copies/mL by the experimental Chiron bDNA
assay) a regimen of VIRACEPT in combination with standard doses of reverse
transcriptase inhibitors, and were then switched to a combination of 400mg
Norvir(R) (ritonavir) BID (twice daily) + 400mg Invirase(R) (saquinavir hard
gel) BID + 40mg Zerit(R) BID + 150mg Epivir(R) BID. Twenty patients had
received antiretroviral therapy before receiving treatment with VIRACEPT, and
the median duration of prior VIRACEPT use for all patients was 48 weeks.
All patients (24/24) experienced an initial response to the new protease
inhibitor-containing regimen, achieving HIV RNA levels below the limit of
quantification (<500 HIV RNA copies/mL, experimental Chiron bDNA assay). At a
median follow-up interval of 60 weeks (40-98 weeks), 58% (14/24) maintained
plasma HIV RNA levels below the limit of quantification in an intent-to-treat
analysis (last observation carried forward). Patients with baseline viral HIV
RNA levels >30,000 copies/mL were less likely to preserve levels below the
limit of quantification. The HIV protease mutations D30N, N88D, or M36I
observed in some patients before switching therapy did not preclude initial
response to treatment.
The most commonly observed adverse event of moderate or greater severity
in clinical trials of VIRACEPT was diarrhea (10-30% of patients), which was
generally controlled with over-the-counter medications. New onset or
exacerbation of diabetes mellitus and hyperglycemia, as well as increased
bleeding in patients with hemophilia types A and B, has been reported with
protease inhibitors.
VIRACEPT is indicated for the treatment of HIV infection when
antiretroviral therapy is warranted. This indication is based on analyses of
surrogate marker changes in patients who received VIRACEPT in combination with
nucleoside analogues or alone for up to 24 weeks. At present, there are no
results from controlled trials evaluating the effect of therapy with VIRACEPT
on clinical progression of HIV infection, such as survival or the incidence of
opportunistic infections.
Agouron Pharmaceuticals, Inc. is an integrated pharmaceutical company
committed to the discovery, development, manufacturing, and marketing of
innovative therapeutic products engineered to inactivate proteins that play
key roles in cancer, AIDS, and other serious diseases.
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.
WIRES: Full prescribing information for VIRACEPT to follow.
VIRACEPT(R) is a registered trademark of Agouron Pharmaceuticals, Inc.
Norvir(R) is a trademark of Abbott Laboratories.
Invirase(R) is a registered trademark of Roche Laboratories, Inc.
Epivir(R) is a registered trademark of Glaxo Wellcome Oncology/HIV.
Zerit(R) is a registered trademark of Bristol-Myers Squibb Company.
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:
Investors: Donna Nichols, Vice President,
Head of Corporate Communications, 619-622-3009; Media: Joy
Schmitt, Associate Director, Product Public Relations,
619-622-3220, both of Agouron Pharmaceuticals, Inc.
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