QUEBEC CITY, Quebec, April 29 /PRNewswire/ -- Today new study results
announced by GlaxoSmithKline showed the pharmacokinetics (PK) of the HIV
protease inhibitor (PI) LEXIVA(R) (fosamprenavir calcium) dosed in combination
with either 100mg or 200mg of the PI ritonavir (RTV) (LEXIVA/r) was not
affected when LEXIVA/r was co-administered once daily (QD) with the nucleotide
reverse transcriptase inhibitor Viread (tenofovir disoproxil fumarate) (TDF).
There also were no significant safety findings when combining LEXIVA/r with
TDF in the 35 healthy male volunteers studied. The data were presented at the
6th International Workshop on Clinical Pharmacology of HIV Therapy.
LEXIVA was co-discovered by GlaxoSmithKline (GSK) and Vertex
Pharmaceuticals.
LEXIVA is indicated for the treatment of HIV infection in adults in
combination with other antiretroviral medications. The following points
should be considered when initiating therapy with LEXIVA/r in PI-experienced
patients: the PI-experienced patient study was not large enough to reach a
definitive conclusion that LEXIVA/r and lopinavir/ritonavir are clinically
equivalent. Once-daily administration of LEXIVA plus RTV is not recommended
for PI-experienced patients.
"These data complement findings from a clinical study of LEXIVA/r in
protease inhibitor-experienced patients wherein plasma amprenavir trough
concentrations were similar for subjects receiving tenofovir as compared to
subjects not receiving tenofovir," said Doug Manion, M.D., vice president for
HIV Clinical Research for the Infectious Diseases Medicines Development Center
(MDC), GlaxoSmithKline.
This study was a prospective, crossover study of 35 male volunteers. All
subjects took LEXIVA/r in combination with TDF 300mg once daily in a fasted
state. One cohort took LEXIVA 1400mg/ritonavir 200mg once daily and the other
cohort took LEXIVA 1400mg/ritonavir 100mg once daily. After 14 days, a 24-
hour PK profile was measured.
Specific results:
No relevant effects of TDF on plasma amprenavir (APV) PK were demonstrated
when once daily TDF 300mg was given in combination with once daily LEXIVA/r
1400/100 or 1400/200.
There were no grade III-IV adverse events in any study group.
Important Safety Information about LEXIVA
HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to
others.
LEXIVA is contraindicated in patients with previously demonstrated
clinically significant hypersensitivity to any of the components of this
product or to amprenavir. Hyperglycemia, new onset or exacerbations of
diabetes mellitus and spontaneous bleeding in hemophiliacs have been reported
with protease inhibitors.
LEXIVA is contraindicated with ergot derivatives, cisapride, pimozide,
midazolam and triazolam. If LEXIVA is co-administered with ritonavir,
flecainide and propafenone are also contraindicated. Treatment with LEXIVA/r
has resulted in increases in the concentration of triglycerides. Triglyceride
and cholesterol testing should be performed prior to initiating therapy with
LEXIVA and at periodic intervals during therapy. The most common adverse
events seen in clinical trials with LEXIVA were diarrhea, nausea, vomiting,
headache and rash.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company
committed to the discovery and development of breakthrough small molecule
drugs for serious diseases. The Company's strategy is to commercialize its
products both independently and in collaboration with major pharmaceutical
companies. Vertex's product pipeline is principally focused on viral
diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes
the HIV protease inhibitor, LEXIVA with GlaxoSmithKline.
LEXIVA is a registered trademark of the GlaxoSmithKline group of
companies.
Vertex's press releases are available at http://www.vrtx.com.
Vertex Safe Harbor Statement
This press release may contain forward-looking statements. While
management makes its best efforts to be accurate in making forward-looking
statements, such statements are subject to risks and uncertainties that could
cause Vertex's actual results to vary materially. These risks and
uncertainties include those risks listed under Risk Factors in Vertex's Form
10-K filed with the Securities and Exchange Commission on March 16, 2005.
Vertex Contacts:
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Media Relations Specialist, (617) 444-6470
GlaxoSmithKline Contacts:
Mary Faye Dark, GSK, (919) 483-2839
Beth Schlesinger, Public Communications Inc., (312) 558-1770
SOURCE Vertex Pharmaceuticals
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Related links:
http://www.vrtx.com
Company News On-Call:
http://www.prnewswire.com/comp/938395.html
CONTACT:
Lora Pike, Manager, Investor Relations,
+1-617-444-6755, or Zachry Barber, Media Relations Specialist,
+1-617-444-6470, both of Vertex; or Mary Faye Dark of GSK,
+1-919-483-2839, or Beth Schlesinger of Public Communications
Inc., +1-312-558-1770, both for GlaxoSmithKline
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