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FDA Approves Administration of LEXIVA with Lower Dose of "Boosting" Medication Ritonavir
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Data Show Lower Dose Associated with Fewer Adverse Events in Healthy Volunteers
Research Triangle Park, NC - October 12, 2007 - GlaxoSmithKline's [NYSE: GSK] HIV protease inhibitor LEXIVA (fosamprenavir calcium) may now be administered with 100mg of ritonavir, an agent that increases, or boosts, the level of protease inhibitors in the bloodstream.
The U.S. Food and Drug Administration approved once-daily LEXIVA 1400 mg with 100mg of ritonavir in adult patients who had not previously taken a protease inhibitor (PI). The approval was based on pharmacokinetic data demonstrating comparable blood plasma levels in healthy volunteers when LEXIVA was administered with the lower 100mg dose of ritonavir and the previously approved 200mg dose of ritonavir. This information has been added to the LEXIVA product label.
LEXIVA is indicated in combination with other antiretrovirals for the treatment of HIV infections. Ritonavir works with LEXIVA and other protease inhibitors to boost the medication level in the bloodstream making the protease inhibitor more effective in suppressing HIV. HIV medicines do not cure HIV infections/AIDS or prevent passing HIV to others.
"GlaxoSmithKline remains committed to improving patient care by making dosing options more convenient," said Mark Shaefer, Pharm. D., Director, Clinical Development at GlaxoSmithKline. "We understand that reducing the number of pills taken daily is an important consideration for patients starting HIV treatment."
The data supporting this label change were published in the February 2007 issue of Antimicrobial Agents and Chemotherapy.
LEXIVA Indication Statement and Background
LEXIVA is indicated for the treatment of HIV infection in combination with other antiretroviral medications. The following points should be considered when initiating therapy with LEXIVA plus ritonavir (LEXIVA/r) in protease inhibitor (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.
The recommended dosing for LEXIVA is:
- Therapy naive adults
- LEXIVA 1400mg twice daily
- LEXIVA 1400mg once daily plus ritonavir 100mg once daily
- LEXIVA 1400mg once daily plus ritonavir 200mg once daily
- LEXIVA 700mg twice daily plus ritonavir 100mg twice daily
- Protease inhibitor experienced adults
- LEXIVA 700mg twice daily plus 100mg ritonavir twice daily
LEXIVA was initially approved by the FDA for use in the US in 2003. It is the first PI to offer flexible dosing options (for PI-naive patients) with no food or water restrictions.
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 (amprenavir). High blood sugar, diabetes or worsening of diabetes, and bleeding in hemophiliacs have occurred in some patients taking protease inhibitors. When patients start taking HIV medicines, their immune system may get stronger and could begin to fight infections that have been hidden in their body, such as pneumonia, herpes virus, or tuberculosis. If patients have new symptoms after starting their HIV medicines, they should tell their 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 patients have HIV and their 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 www.LEXIVA.com.
LEXIVA was co-discovered by GlaxoSmithKline and Vertex Pharmaceuticals Incorporated.
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 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 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 focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection. Vertex co-discovered the HIV protease inhibitor, LEXIVA, with GlaxoSmithKline.
Inquiries
US Media Inquiries: Michael N. Joyner (919) 483 2839
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