Comparison of Triple and Binary Class Therapies
In Nucleoside Experienced Patients
SAN FRANCISCO, Feb. 2 /PRNewswire/ -- Agouron Pharmaceuticals, Inc. today
reported that among HIV-infected patients who failed exclusive treatment with
nucleoside reverse transcriptase inhibitors (NRTIs), those patients switching
to a triple class regimen containing the HIV protease inhibitor (PI)
VIRACEPT(R) (nelfinavir mesylate) reported significantly greater and more
durable reductions in plasma HIV RNA at 48 weeks when compared to those
receiving a binary (two-class) regimen. Investigators will present results
from the Adult AIDS Clinical Trial Group (AACTG) 364 study this week at the
7th Conference on Retroviruses and Opportunistic Infections in San Francisco,
California.
In a randomized clinical trial, 195 patients were evaluated in a study to
compare one triple class and two binary class combination antiretroviral
therapies in the following arms, respectively: A. VIRACEPT + efavirenz +
NRTIs; B. VIRACEPT + placebo + NRTIs; C. efavirenz + placebo + NRTIs. All
patients had previously failed combination therapy (relapsing to >500 HIV RNA
copies/mL as measured by the Amplicor HIV-1 Monitor Assay) in treatment
exclusively with standard doses of approved NRTIs; at study entry they were
assigned one or two new open-label NRTIs regardless of study arm.
Median baseline HIV RNA for patients across all arms of the study was
7776 copies/mL. At 48 weeks by on-treatment analysis, 67% of the triple class
treated patients (Arm A) had achieved plasma HIV RNA levels below the limit of
quantification (<50 copies/mL by an ultrasensitive assay), compared to 22% and
44% of binary class treated patients (Arms B & C, respectively). Genotypic
analyses were conducted to further explore the basis for the results from the
two-class arms of the trial. At week 16, among those experiencing viral
rebound to plasma HIV RNA >200 copies/mL after study initiation, it took
significantly longer for patients to breach this higher plasma HIV RNA level
in the PI + NNRTI + NRTI treated group (Arm A) compared to Arms B & C.
The Adult AIDS Clinical Trials Group (AACTG) is a multicenter cooperative
clinical trials group involved in all phases of clinical research, from early
safety studies to large-scale efficacy trials. It evaluates new drugs and
drug combinations for the treatment of HIV infection in adults.
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.
 back to top
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:
Joy Schmitt, Associate Director, Product
Public Relations, Agouron Pharmaceuticals, Inc., 858-622-3220
|
