-- Simple tablet form -- the lower-strength tablet is more convenient to
administer than the oral solution.
-- Dosing is with or without food, providing patients greater
flexibility -- the current soft capsule formulation should be taken
-- No required refrigeration -- unlike the current soft capsule
formulation or oral solution, which require refrigeration, the new
Kaletra tablet can be stored at room temperature.
"HIV/AIDS continues to have a devastating effect on millions of children around the world, especially those patients living in resource-limited settings," said Scott Brun, M.D., divisional vice president, infectious diseases, Global Pharmaceutical Research and Development, Abbott. "The new lower-strength Kaletra formulation is another example of Abbott's continued commitment to advancing treatment and care for the HIV community."
Kaletra Lower-Strength Tablet Availability
Based on the U.S. Food and Drug Administration (FDA) approval on Nov. 9, 2007, Abbott is shipping the lower-strength tablets to countries that have issued approved waiver orders. On Dec. 1, 2007, Uganda, the first country to issue such a waiver order, was one of the first countries in the world -- and the first country in Africa -- to receive the lower-strength tablets. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), an estimated 110,000 Ugandan children were living with HIV in 2005. Other African governments are now also talking to Abbott about the possibility of waiver shipments.
The World Health Organization recommends lopinavir/ritonavir as the preferred treatment for children who no longer respond to first-line HIV medicine. The U.S. Department of Health and Human Service recommends lopinavir/ritonavir for the initial treatment of children with HIV.
Kaletra Lower-Strength Tablets
The new tablet formulation will complement Kaletra oral solution, which has been available for pediatric use since its U.S. approval in September 2000. For pediatric patients, lower-strength Kaletra tablets will offer more dosing flexibility. The tablets contain 100mg of lopinavir and 25mg of ritonavir, compared with the original tablet strength of 200mg of lopinavir and 50mg of ritonavir, most commonly used by adults.
The price of the lower-strength tablet will be half the price of the original-strength tablet everywhere it is available.
Abbott's Commitment to Fighting HIV/AIDS
HIV/AIDS is a global problem that demands shared commitment and shared responsibility. Abbott is committed to working with governments, multilateral organizations, nongovernmental organizations (NGOs) and patient groups to expand access to HIV treatments around the world. Abbott has also made significant investments in expanding manufacturing capacity to meet the growing demand for HIV treatment in developing countries.
Abbott's lopinavir/ritonavir formulations are among the lowest-priced protease inhibitors in the developing world. Abbott has been providing its HIV medicines at a price of US$500 per adult patient per year in all African and least developed countries (LDCs) since 2002, making these medicines more affordable than any generic copies.
Abbott and the company's philanthropic foundation Abbott Fund have invested more than US$100 million in the fight against HIV/AIDS in Africa and the developing world. Abbott Fund-supported programs have served more than 700,000 children and families. In addition, more than 250,000 patients have been tested through Abbott Fund-supported voluntary counseling and testing programs, with thousands being referred to treatment programs. Abbott also has donated more than 8 million rapid HIV tests to help prevent mother-to-child HIV transmission.
Abbott and Abbott Fund also have announced several efforts to expand access to treatment and care for children living with HIV/AIDS, including an additional investment of US$12 million in grants and product donations this year.
Background on HIV in Children
According to UNAIDS, in 2007, an estimated 2.5 million children under the age of 15 were living with HIV worldwide; a vast majority -- almost 90 percent of children with HIV -- were living in sub-Saharan Africa. Last year alone, an estimated 420,000 children under age 15 were newly infected with HIV, and 330,000 children under age 15 died of AIDS.
Indication and Important Safety Information for lopinavir/ritonavir
Kaletra is indicated for the treatment of HIV-1 infected adults and children above the age of two years. It is used in combination with other antiretroviral agents. Kaletra does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others.
Kaletra Important Safety Information
Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information visit http://www.KALETRA.com. Kaletra should not be taken by patients who have had an allergic reaction to any of its ingredients, including lopinavir or ritonavir, or any of the excipients, or by patients with severe liver problems.