Agouron's Women First Study is the First of its Kind
LA JOLLA, Calif., Feb. 3 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
(Nasdaq: AGPH) today announced preliminary results from an ongoing women's
study called Women First, to evaluate the safety, efficacy, and tolerability
of the HIV protease inhibitor VIRACEPT(R) (nelfinavir mesylate) in combination
therapy specifically in women, a patient group typically comprising about
10% of participants in previous trials of antiretroviral therapy. This study
is also evaluating the efficacy in women of twice daily (BID) and three times
daily (TID) dosing regimens in combination therapy. Results from Women First
will be presented this week at the 6th Conference on Retroviruses and
Opportunistic Infections in Chicago, Illinois.
In an ongoing study at six sites that will continue for two years,
68 HIV-infected women not previously treated with a protease inhibitor
(PI naive) were randomized into two groups. The BID dosing group, with a mean
baseline HIV RNA level in plasma of 4.9 log10 copies/mL, received 1250mg
VIRACEPT BID + 1000mg Invirase(R) (saquinavir hard gel capsules) BID +
standard doses of Zerit(R) (d4T or stavudine) and Epivir(R)
(3TC or lamivudine). The TID dosing group, with a mean baseline HIV RNA level
in plasma of 4.8 log10 copies/mL, received the standard doses of 750mg
VIRACEPT TID + 600mg saquinavir hard gel capsules TID + standard doses of
stavudine and 3TC.
Similar improvements in antiviral markers were seen in an on-treatment
analysis of patients from both groups who have reached the 12 month time
point. At 12 months, HIV RNA in plasma was below the limit of quantification
by the Roche AMPLICOR(TM) HIV-1 Monitor test (<400 copies HIV RNA/mL) in
approximately 91% of patients (10/11) in the BID dosing group and 73% of
patients (8/11) in the TID dosing group. Seventy-three percent of patients
(8/11) in the BID dosing group and 73% of patients (8/11) in the TID dosing
group achieved HIV RNA levels below the limit of quantification by an
experimental ultrasensitive assay (<50 copies/mL) at 12 months, with mean
reductions of 2.89 log10 and 2.25 log10 in those dosing groups, respectively.
The Women First study is also addressing compliance issues inherent in a
combination treatment regimen. Tools are used to educate patients living with
HIV, and to assist them in integrating the medications into their daily
routines. Resources supplied to patients include pill boxes labeled with the
proper dosing schedules, dosing instruction cards, patient planners,
personalized graphs tracking their individual HIV RNA and CD4+ T-cell counts,
and bimonthly patient newsletters to provide continuing education and feedback
on disease management issues.
"The Women First study has been a significant opportunity for HIV-positive
women to participate in a study that is specifically focused on their
treatments and outcomes," said Judith Currier, M.D., Women First Principal
Investigator at the University of California at Los Angeles. "This study is
of unique concern to HIV-positive women and will provide insight into the use
of VIRACEPT in their daily lives."
VIRACEPT-containing combination therapy was generally well-tolerated in
HIV-infected women after 48 weeks of therapy in the Women First study. In
this study, diarrhea of moderate or greater severity occurred in 4% of
patients. 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 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.
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 trademarks of Glaxo Wellcome Oncology/HIV.
AMPLICOR(TM) is a trademark of Roche Laboratories, 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:
Investors: Donna Nichols, Vice President,
Head of Corporate Communications, 619-622-3009, or Media: Joy
Schmitt, Associate Director, Product Public Relations,
619-622-3220, both of Agouron Pharmaceuticals
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