LA JOLLA, Calif., Feb. 4 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
(Nasdaq: AGPH) today reported positive results in patients who, after failing
treatment with VIRACEPT(R) (nelfinavir mesylate), were treated with other
protease inhibitors and experienced favorable anti-HIV responses. Results
from the multicenter study were presented at the 5th Conference on
Retroviruses and Opportunistic Infections in Chicago.
Pablo Tebas, M.D., from Washington University in St. Louis, MO, reported
an evaluation of 26 patients from key clinical trials of VIRACEPT (studies 506
and 511) who had received VIRACEPT for an average of 55 weeks prior to
experiencing virologic failure (two consecutive HIV viral RNA assays >5000
copies/mL). These patients were then switched to a combination of 400mg
Norvir(TM) (ritonavir) BID (twice daily) + 400mg Invirase(R) (saquinavir hard
gel) BID + 40mg Zerit(R) (d4T or stavudine) BID and 150mg Epivir(R) (3TC or
lamivudine) BID. Of the 26 patients, 21 had received antiretroviral therapy
before receiving treatment with VIRACEPT.
Twenty-four weeks after switching from VIRACEPT, 68% of patients (13/19)
had viral loads (the amount of HIV in plasma) below the limit of detection
using the bDNA assay (a branch DNA-based assay with a lower limit of
quantification of <500 HIV RNA copies/mL). Two patients discontinued the
study during the first four weeks due to GI intolerance.
Genotypic analyses were conducted on virus from 16 of the patients prior
to their switching from VIRACEPT therapy. The most frequently observed
mutations were D30N (the mutation commonly associated with resistance to
VIRACEPT) in 11 of the patients, and L90M (a mutation commonly associated with
resistance to saquinavir) in 5 patients. No increase in risk of virologic
failure was observed for patients with the L90M mutation at baseline.
The most commonly observed adverse event of moderate or greater severity
in clinical trials of VIRACEPT was diarrhea, 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, have 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 analogs 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 discovery, development, manufacturing, and marketing of small
molecule drugs 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(TM) is a trademark of Abbott Laboratories.
Invirase(R) is a registered trademark of Roche Laboratories Inc.
Zerit(R) is a registered trademark of Bristol-Myers Squibb Company.
Epivir(R) is a registered trademark of Glaxo Wellcome Oncology/HIV.
SOURCE Agouron Pharmaceuticals, Inc.
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Related links:
http://www.agouron.com
CONTACT:
Investors: Donna Nichols, Vice President,
Head of Corporate Communications, 619-622-3009, or Media: Joy
Schmitt, Manager, Product Public Relations, 619-622-3220, both of
Agouron Pharmaceuticals, Inc.
CNOC: http://www.prnewswire.com or fax, 800-758-5804, ext.
019650
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