RIO DE JANEIRO, Brazil, July 26 /PRNewswire-FirstCall/ -- HIV patients
with hepatitis C (HCV) or B (HBV) had no negative effect to liver enzymes
through 120 weeks of treatment (n=35) with a once-daily (QD) dose of LEXIVA(R)
(fosamprenavir calcium) boosted with ritonavir (LEXIVA/r) as part of an
antiretroviral regimen. These data were from a retrospective analysis of a
subset of patients in study APV30002/APV30005 and were presented here today at
the 3rd Annual International AIDS Society (IAS) Conference on HIV Pathogenesis
and Treatment. There are no data on the use of Lexiva in combination with
ritonavir in patients with any degree of hepatic impairment.
"It is encouraging that the liver enzymes remained stable in co-infected
patients," said Mark Shaefer, Pharm. D., Acting Vice President, HIV,
Infectious Disease Medicine Development Center at GlaxoSmithKline.
LEXIVA is an HIV protease inhibitor (PI) that was co-discovered by
GlaxoSmithKline (GSK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX).
It is the first PI with flexible dosing and no food or water restrictions.
LEXIVA is indicated in combination with other antiretroviral agents for
the treatment of HIV infection in adults. 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 ritonavir is not recommended for PI-
experienced patients.
Among results of the 120-week analysis presented at IAS:
* Median decreases of -5 u/L alanine aminotransferase (ALT) and -9 u/L
aspartate aminotransferase (AST) were observed among 35 patients with
HCV or HBV infection. ALT and AST are enzymes that, when elevated, may
be markers for liver disease.
* Median decreases of -8 u/L in ALT and -8 u/L in AST were observed among
134 patients without hepatitis co-infection.
* There were few new treatment-emergent Grade 3-4 ALT or AST toxicities
observed between week 48 and week 120.
* The incidence of adverse events was comparable between patients co-
infected with hepatitis and those without co-infection.
The 48-week data are from the SOLO trial, an open-label, multi-center
study evaluating the safety and efficacy of QD dosing of LEXIVA/r in 649
treatment-naive patients. LEXIVA/r was administered as part of a regimen that
also included abacavir sulfate (ABC) and lamivudine (3TC). The study
presented at IAS analyzed data from patients who completed 48 weeks of
treatment in the SOLO study and were enrolled in an ongoing study (APV30005)
of long-term treatment results.
"Approximately 25 percent of HIV patients in the developed world are co-
infected with HCV or HBV, and effective antiretroviral therapy has been
associated with slower progression of liver disease," said Edwin DeJesus,
M.D., study investigator, Orlando Immunology Center, Orlando, Florida.
"Safety data from long-term trials such as SOLO and APV30005 -- especially
with regard to liver toxicity -- are important information in optimizing
treatment for HIV patients."
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.
Redistribution/accumulation of body fat including central obesity,
dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial
wasting, breast enlargement, and "cushingoid appearance" have been observed in
patients receiving antiretroviral therapy. The causal relationship,
mechanism, and long-term consequences of these events are currently unknown.
LEXIVA should be used with caution in patients with a known sulfonamide
allergy.
Severe or life-threatening skin reactions were reported in less than 1
percent of 700 patients treated with LEXIVA in clinical studies, including one
case of Stevens-Johnson syndrome.
Skin rashes (all grades, without regard to causality) occurred in
approximately 19 percent of patients treated with LEXIVA in the pivotal
efficacy studies. This led to the discontinuation of LEXIVA in less than 1
percent of patients.
During the initial phase of treatment, patients responding to
antiretroviral therapy may develop an inflammatory response to indolent or
residual opportunistic infections.
LEXIVA is contraindicated with ergot derivatives, cisapride, pimozide,
midazolam, and triazolam. If LEXIVA is coadministered with ritonavir,
flecainide and propafenone are also contraindicated. Caution should be used
when coadministering medications that are substrates, inhibitors, or inducers
of CYP3A4, or potentially toxic medications that are metabolized by CYP3A4.
Serious and/or life-threatening drug interactions could occur between LEXIVA
and amiodarone, lidocaine (systemic), tricyclic antidepressants, and
quinidine. Concentration monitoring of these agents is recommended if these
agents are used concomitantly with LEXIVA. LEXIVA should not be
coadministered with rifampin, St. John's wort, lovastatin, simvastatin, or
delavirdine. Particular caution should be used when prescribing
phosphodiesterase (PDE-5) inhibitors for erectile dysfunction (eg, sildenafil
or vardenafil) in patients receiving LEXIVA. This list of potential drug
interactions is not complete.
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 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-promotes
the HIV protease inhibitor, LEXIVA(R), with GlaxoSmithKline.
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.
LEXIVA(R) is a registered trademark of the GlaxoSmithKline group of
companies.
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, Specialist, Media Relations, (617) 444-6470
GSK Contact:
Mary Faye Dark, GlaxoSmithKline, (919) 483-2839
SOURCE Vertex Pharmaceuticals Incorporated
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Related links:
http://www.vrtx.com
http://www.LEXIVA.com http://www.bridgestoaccess.gsk.com
Company News On-Call:
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, Specialist, Media
Relations, +1-617-444-6470, all of Vertex; or Mary Faye Dark of
GlaxoSmithKline, +1-919-483-2839
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