- LEXIVA(R)/R Twice-Daily Provided Comparable Efficacy to Kaletra
Twice-Daily in Treatment-Naive HIV Patients -
TORONTO, Aug. 17 /PRNewswire-FirstCall/ -- This month, The Lancet
published results of a study showing that HIV regimens using LEXIVA
(Telzir) Tablets+ritonavir and Kaletra (lopinavir/ritonavir) Capsules both
given twice-daily had comparable (non-inferior) efficacy and tolerability
in adults who had no previous exposure to HIV medicines. Parts of this
study were also presented at this week's International AIDS Conference in
Toronto, Canada.
The publication of the 48-week clinical study known as KLEAN (Kaletra
vs. LEXIVA with Epivir(R) (lamivudine) and Abacavir in ART-Naive patients)
was announced today by GlaxoSmithKline and Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX), the companies that co-discovered LEXIVA.
LEXIVA is indicated for the treatment of HIV infection in adults in
combination with other antiretroviral medications. Once-daily
administration of LEXIVA/r is not recommended for PI-experienced patients.
"Protease inhibitors continue to be a key component of antiretroviral
therapy and this new information reinforces the efficacy and safety of
LEXIVA/r for treatment-naive patients with HIV," said Joseph Eron, Jr., MD,
Professor of Medicine, Division of Infectious Diseases, University of North
Carolina at Chapel Hill.
Study Explained
The publication reported results from the KLEAN study, a randomized,
open-label, multicenter, international Phase IIIb trial comparing LEXIVA/r
twice-daily to lopinavir/r twice-daily in treatment-naive patients. The
study included 878 patients with HIV-1 RNA (vRNA) >1,000 copies/mL (c/mL)
and any CD4+ cell count during the pre-trial screening. Patients were
randomized to receive either LEXIVA/r or lopinavir/r twice daily,
administered with Epzicom(TM) (abacavir/lamivudine) once daily, with 434
patients in the LEXIVA/r arm and 444 in the lopinavir/r arm.
Primary endpoints were the proportion of subjects with vRNA <400 c/mL
at week 48 and treatment discontinuations due to adverse events. These
results were analyzed according to intent to treat exposed TLOVR (Time to
Loss of Virologic Response). Protocol-defined virologic failure was defined
as failure to achieve HIV RNA <400 c/mL by week 24 or confirmed rebound
greater than or equal to 400 c/mL. Seventy-seven percent of the patients
(676) completed the study, with 12 percent and 10 percent of patients
discontinuing treatment due to adverse events in the LEXIVA/r and Kaletra
arms, respectively.
LEXIVA/r administered twice-daily was shown to be non-inferior to
lopinavir/r given twice-daily over 48 weeks. At 48 weeks, 73 percent (315)
of the patients treated with LEXIVA/r achieved vRNA <400 c/mL, and 71
percent (315) of the patients in the lopinavir/r arm achieved this
measurement by week 48. At 48 weeks, 66 percent (285) of the patients
treated with LEXIVA/r and 65 percent (288) of the lopinavir/r patients
achieved vRNA <50c/mL. The median CD4 cell increase in patients at 48 weeks
was 176 c/ml in patients who received LEXIVA/r and 191 c/ml in patients who
received lopinavir/r.
The most frequently reported drug related Grade 2 - 4 adverse events
reported in the study included diarrhea (13 percent, 11 percent), nausea (6
percent, 5 percent) and abacavir hypersensitivity reaction (6 percent, 4
percent) in the study arms containing LEXIVA/r and lopinavir/r,
respectively. Similar increases in fasting lipid values were also observed
in both regimens. Adverse events in this study were consistent with those
described in the product information for LEXIVA and Kaletra.
LEXIVA INDICATION STATEMENT AND BACKGROUND
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.
LEXIVA was co-discovered by GlaxoSmithKline and Vertex Pharmaceuticals
Incorporated. LEXIVA was approved by the FDA for use in the US in 2003.
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.bridgestoaccess.gsk.com
http://www.treathiv.com http://www.LEXIVA.com
http://www.prnewswire.com/comp/938395.html/
CONTACT:
Michael Partridge, Director, Corporate
Communications, +1-617-444-6108, 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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