TORONTO, Aug. 13 /PRNewswire-FirstCall/ -- Updated treatment guidelines
issued today by the International AIDS Society-USA (IAS-USA) now include
the HIV protease inhibitor LEXIVA(R) boosted with ritonavir as a
recommended option for protease inhibitor-based regimens in the initial
treatment of adults with HIV infection. These guidelines were presented
today at the International AIDS Conference (IAC) in Toronto, Canada.
LEXIVA is a protease inhibitor that was co-discovered by
GlaxoSmithKline and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX).
LEXIVA is indicated in combination with other antiretroviral agents for the
treatment of HIV infection in adults. LEXIVA was approved by the FDA for
use in the US in 2003. (Please see the LEXIVA INDICATION STATEMENT section
for the full indication language.)
Recent research has shown that LEXIVA/r offers comparable
(non-inferior) efficacy and safety to lopinavir/r when both are given
twice-daily as part of an HIV regimen in patients starting therapy. Based
on these data, the IAS-USA included LEXIVA/r as a recommended component of
initial antiretroviral therapy.
The IAS-USA commissions expert panels to issue recommendations and
guidelines to provide standard approaches to patient care. The updated
guidelines published in the current issue of the Journal of the American
Medical Association (JAMA) stated that, "[t]he choice of initial drug
centers on acceptability; predicted tolerance; pill burden; comorbid
conditions; short-term, mid-term and long term adverse event profiles."
The updated guidelines reflect the international perspectives of the
panelists and are designed to serve as a tool for clinicians in countries
where resources are sufficient to provide relatively unrestricted choices
of drugs.
"We are pleased to see that the guidelines committee has recognized
LEXIVA as an important treatment option for patients with HIV," said Mark
Shaefer, Director, Clinical Development, HIV Infectious Disease Medicine
Development Center at GSK.
LEXIVA INDICATION STATEMENT
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 plus ritonavir
(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 ritonavir is not recommended for PI-experienced patients.
IMPORTANT SAFETY INFORMATION ABOUT LEXIVA
HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to
others.
Patients should not take LEXIVA if they have had an allergic reaction
to LEXIVA or AGENERASE(R) (amprenavir). High blood sugar, diabetes or
worsening of diabetes, and bleeding in hemophiliacs have occurred in some
patients taking protease inhibitors. When a patient starts taking HIV
medicines, his immune system may get stronger and could begin to fight
infections that have been hidden in his body, such as pneumonia, herpes
virus, or tuberculosis. If a patient has new symptoms after starting his
HIV medicines, he should tell his doctor. Changes in body fat may occur in
some patients taking antiretroviral therapy. The cause and long-term health
effects of these conditions are not known at this time. Skin rashes can
occur in patients taking LEXIVA. Rarely, rashes were severe or life
threatening. Opportunistic infections can develop when a patient has HIV
and his immune system is weak. It is very important that patients see their
healthcare provider regularly while taking LEXIVA to discuss any side
effects or concerns. Most common side effects in clinical studies were
diarrhea, headache, nausea, rash, and vomiting. In most cases, these side
effects did not cause people to stop taking their medicine.
For full prescribing information for LEXIVA, please visit
http://www.treathiv.com
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and an industry leader in HIV
research and therapies. The company is engaged in basic research programs
designed to investigate new targets to treat HIV. For full prescribing
information please go to http://www.LEXIVA.com.
GSK's Bridges to Access program can help provide qualified individuals
with access to GSK's antiretroviral medications, as well as help identify
insurance or other support for medications. Patients may be eligible for
this program if they are not eligible for prescription drug benefits
through any other private or public insurer, payer or program. In 2004,
GlaxoSmithKline donated more than $372.5 million worth of prescription
drugs to 475,000 patients. For more information, visit
http://www.bridgestoaccess.gsk.com or call 1-866-PATIENT.
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-discovered the HIV protease inhibitor, LEXIVA, with GlaxoSmithKline.
Vertex's press releases are available at http://www.vrtx.com.
Vertex Contacts:
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Senior Media Relations Specialist, (617) 444-6470
GSK Media Contact:
Marc Meachem, (919) 483-2839
SOURCE Vertex Pharmaceuticals Incorporated
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Related links:
http://www.vrtx.com
http://www.treathiv.com http://www.LEXIVA.com
http://www.bridgestoaccess.gsk.com
http://www.prnewswire.com/comp/938395.html /
CONTACT:
Michael Partridge, Director, Corporate
Communications, +1-617-444-6108, or Lora Pike, Manager, Investor
Relations, +1-617-444-6755, or Zachry Barber, Senior Media
Relations Specialist, +1-617-444-6470, all of Vertex; or Marc
Meachem of GSK Media, +1-919-483-2839
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