Twice Daily Dosing of Viracept Demonstrates Activity at 48 Weeks
PR Newswire, Friday, September 25, 1998 at 13:42
LA JOLLA, Calif., Sept. 25 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
(NASDAQ:AGPH) reported preliminary data today from several clinical studies
indicating that twice daily dosing of its HIV protease inhibitor VIRACEPT(R)
(nelfinavir mesylate) in combination therapy produces anti-HIV effects at 48
weeks comparable to those resulting from standard three times daily dosing of
the drug in combination therapy. Results from clinical studies carried out in
Europe and in the U.S. were reported this week by clinicians at the 38th
Interscience Conference on Antimicrobial Agents and Chemotherapy in San Diego,
California.
In an ongoing European study conducted at 24 sites that will continue for
96 weeks, approximately 283 patients were initially randomized to receive
either the standard three times daily (TID) dose of 750mg VIRACEPT or one of
three twice daily (BID) VIRACEPT doses (1250mg, 1000mg, or 750mg) in
combination with standard doses of Zerit(R) (d4T or stavudine) and Epivir(R)
(3TC or lamivudine). The study protocol was subsequently amended to
consolidate the comparison to the 1250mg BID vs. 750mg TID VIRACEPT regimens
in a total of 360 patients.
Preliminary results from the BID dosing groups were compared with results
from the TID dosing group. HIV in plasma fell below the limit of detection by
the Roche AMPLICOR(TM) assay (<400 HIV RNA copies/mL) at 48 weeks in
approximately 80% of patients in both the BID dosing groups (132/165) and the
TID dosing group (48/59). Sixty-eight percent of patients (112/164) in the
BID dosing groups and 64% of patients (38/59) in the TID dosing group achieved
viral loads below the limit of detection when tested with an experimental
ultrasensitive assay (<50 copies/mL) at 48 weeks.
Mean CD4+ T-cell counts (infection-fighting cells of the immune system) at
48 weeks increased by 195 cells/mm3 and 174 cells/mm3 in the BID groups and
the TID group, respectively. Prior to treatment, the mean viral load (the
amount of HIV in plasma) of patients was approximately 5.0 log10 viral
copies/mL of plasma. The mean baseline CD4+ T-cell counts were 273 and 254
cells/mm3 in the BID and TID groups, repectively. Patients enrolled in this
study had less than six months of prior nucleoside antiretroviral therapy.
The only side effect of moderate or greater intensity to occur in more
than 5% of patients receiving VIRACEPT was diarrhea, which occurred at a rate
of 17% and 12%, respectively, in the BID and TID groups. 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.
These European data were generally consistent with results presented from
pilot studies conducted at three sites in the United States. Three 48-week
studies were designed to assess BID regimens of VIRACEPT in combination with
two nucleoside analogs. At baseline, the mean viral load of the 34 patients
enrolled in these studies was 4.8 log10 copies/mL, and their mean CD4+ T-cell
count was 392 cells/mm3. Patients received 1250mg VIRACEPT BID + d4T + 3TC,
1250mg VIRACEPT BID + AZT + 3TC, or 1000mg VIRACEPT BID + AZT + 3TC. At 24
weeks, those patients who received the 1000mg VIRACEPT regimen were then
increased to 1250mg VIRACEPT BID + AZT + 3TC for the remainder of the study.
Of the 20 patients who were evaluated at week 48, 80% of patients (16/20)
achieved viral loads below the limit of detection (<400 copies HIV RNA/mL);
79% of patients (15/19) tested with an experimental ultrasensitive assay (<50
copies/mL) at 48 weeks also achieved viral loads below the limit of detection.
Patients' mean CD4+ T-cell increase from baseline was 104 cells/mm3.
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 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.
This press release may contain forward-looking statements or predictions.
These statements represent the company's judgment as of this date and are
subject to risks and uncertainties (including those associated with regulatory
approvals and the impact of competitive products) that could cause the actual
results to differ materially. Important factors concerning these risks are
discussed in Agouron's Form 10-K for the fiscal year ended June 30, 1998
currently on file with the Securities and Exchange Commission. Agouron
undertakes no obligation to publicly release the result of any revisions to
such forward-looking statements which may be made to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events.
For further information about Agouron Pharmaceuticals, Inc., or about
VIRACEPT, please see Agouron's website at 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.
Zerit(R) is a registered trademark of Bristol-Myers Squibb Company.
Retrovir(R) and Epivir(R) are registered trademarks of Glaxo Wellcome
Oncology/HIV.
AMPLICOR(TM) is a trademark of Roche Laboratories, Inc.
SOURCE Agouron Pharmaceuticals, Inc.
-0- 09/25/98
/CONTACT: Investor Contact: Donna Nichols, Vice President, Head of
Corporate Communications, of Agouron Pharmaceuticals, Inc., 619-622-3009/
/Company News On-Call: prnewswire.com or fax, 800-758-5804,
ext. 019650/
/Web site: agouron.com |
