SAN FRANCISCO, Feb. 2 /PRNewswire/ -- Agouron Pharmaceuticals, Inc. today
announced results from the Pediatric AIDS Clinical Trials Group (PACTG) study
353 of the HIV protease inhibitor VIRACEPT(R) (nelfinavir mesylate) in
combination therapy specifically in pregnant women, and the impact of
gestational and postpartum treatment on HIV infection on mothers and newborns.
Results will be presented at the 7th Conference on Retroviruses and
Opportunistic Infections in San Francisco, California.
In this open-label study, HIV-infected pregnant women ranging from 14 to
34 weeks of gestation were enrolled and received oral doses of 750 mg
VIRACEPT(R) (nelfinavir mesylate) three times daily (TID) plus standard oral
doses of Retrovir(R) (zidovudine) and Epivir(R) (3TC or lamivudine), both
during and after pregnancy. In labor, VIRACEPT and lamuvidine were
administered orally, and zidovudine was administered intravenously.
Of the 10 women enrolled, 8 completed the study and 2 did not carry to
term for obstetrical reasons not related to treatment. There was a decrease
in maternal levels of plasma HIV RNA during the course of treatment, with a
median decline from baseline to delivery of -1.8 log10 and from baseline to
six weeks postpartum of -2.4 log10 (p=0.01). For 6/8 patients (75%), plasma
HIV RNA levels were below the level of quantification (<400 copies/mL) at
delivery. Median maternal CD4 cell count at baseline was 220 cells/mm3, and
increased to 308 and 415 cells/mm3 at delivery and six weeks postpartum,
respectively.
All eight infants were born free of HIV infection at a median gestational
age of 38 weeks (range 35-40 weeks). In this study, infants received VIRACEPT
(10mg/kg TID) in combination with weight-adjusted doses of zidovudine and
lamivudine. Transient decreases in hemoglobin and/or neutrophils were
reported, which were resolved after discontinuation of zidovudine. At one
week of life the median VIRACEPT levels in infants were low, and further study
of a higher dose (40 mg/kg BID) is underway. The safety, effectiveness and
pharmacokinetics of VIRACEPT have not been evaluated in pediatric patients
below the age of 2 years.
There are no adequate and well-controlled studies of the use of VIRACEPT
in pregnant women. Therefore, VIRACEPT should be used during pregnancy only
if clearly needed. The US Public Health Service Centers for Disease Control
and Prevention advises HIV-infected women not to breast-feed to avoid
postnatal transmission of HIV to a child who may not yet be infected.
Agouron is a member of the Antiretroviral Pregnancy Registry, a
confidential, multi-company database that tracks the effects of antiretroviral
medications on the infants of pregnant women with HIV. Physicians are
encouraged to register patients by calling 1-800-258-4263.
VIRACEPT in combination with other antiretroviral agents is indicated for
the treatment of HIV infection. This indication is based on analyses of
changes in HIV RNA levels and CD4 cell counts in controlled studies in which
patients received VIRACEPT in combination with nucleoside analogues or alone
for up to 48 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.
VIRACEPT 1250 mg (five 250 mg tablets) BID demonstrated a safety profile
similar to that of VIRACEPT 750 mg TID, with the majority of adverse events of
mild intensity. In study 542, diarrhea of moderate or severe intensity was
the most frequently reported adverse event, occurring in 14% to 18% of
patients receiving VIRACEPT 1250 mg BID or 750 mg TID with stavudine or
lamivudine. When diarrhea occurred, it was generally managed with
nonprescription antidiarrheals.
New onset or exacerbation of diabetes mellitus and hyperglycemia, changes
in the distribution of body fat, and increased bleeding in patients with
hemophilia types A and B have been reported with protease inhibitors.
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.
Agouron Pharmaceuticals, Inc., a wholly owned subsidiary of the
Warner-Lambert Company (NYSE: WLA), 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. Agouron employs more
than 1200 people of whom approximately 800 are engaged in research and
development.
WIRES: Full prescribing information for VIRACEPT to follow.
VIRACEPT(R) and Agouron(R) are registered trademarks of Agouron
Pharmaceuticals, Inc.
SOURCE Agouron Pharmaceuticals, Inc.
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http://www.prnewswire.com/comp/019650.html or fax,
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CONTACT:
Joy Schmitt, Associate Director, Product
Public Relations of Agouron Pharmaceuticals, 858-622-3220
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