Abbott Statement on Advancing Pediatric HIV Treatment in Developing Countries

Published 03-14-06

Submitted by Abbott

ABBOTT PARK, Ill. - Following today's announcement of the U.S. government's new public-private initiative for pediatric AIDS treatment, Abbott pledges its support and active engagement in the initiative to create solutions to advance treatment for children with HIV. Abbott has been a longstanding leader in improving the lives of children affected by HIV/AIDS. The company continues to make a significant contribution through advances in pediatric HIV treatment, and through philanthropic programs targeting critical areas of need for children.

Advancing Pediatric HIV Treatment
Abbott is developing a lower-dose pediatric tablet formulation of its HIV protease inhibitor (PI), lopinavir/ritonavir. Using a novel technology called Meltrex® developed through significant investment by Abbott, the new tablets are being developed with the goals of eliminating the need for refrigeration of the tablets, and to provide the dosing flexibility needed for treating children.

Long-Standing Access to Pediatric Formulations
The treatment needs of children have always been an integral part of Abbott's HIV research programs. Abbott invested in clinical studies of both of its PIs in children at the same time as it studied the medicines for adult use, and the oral solution formulations of both PIs have demonstrated safety and effectiveness in pediatric HIV treatment. Abbott's PIs are both available in liquid formulations around the world to provide flexible dosing for children. In Africa and the Least Developed Countries (LDCs), Abbott has provided its PI liquid formulations at the lowest price of any PI liquid formulation in Africa, including both branded and generic PIs.

Philanthropic Programs Improving the Lives of Children
Abbott and the Abbott Fund are investing $100 million to fight HIV/AIDS in developing countries, including several programs directly addressing barriers to testing, treatment and care of children with HIV:

Pioneering a new pediatric treatment model - The Abbott Fund supported Baylor College of Medicine in establishing a treatment program in Constanta, Romania, that reduced the death rate for children with HIV by more than 90 percent in three years. This model program is now being replicated by Baylor across Africa, providing treatment for more than 4,000 children with HIV. In partnership with Baylor and the Government of Malawi, the Abbott Fund is supporting the opening of the first pediatric treatment center in Malawi in mid-2006.

Training health professionals in pediatric HIV care - Baylor and the Abbott Fund also partnered to establish the Baylor Children's Clinical Centers of Excellence Network to train health professionals and share best practices in HIV care. Additionally, the Abbott Fund supports Baylor's International Pediatric HIV/AIDS Fellowship program, which provides pediatric HIV training for physicians from developing countries.

Supporting orphans and vulnerable children impacted by HIV/AIDS - The Abbott Fund provides care and support for children through innovative model programs that address specific community needs, including HIV testing, legal assistance for women and children, child-focused counseling and support groups, and vocational training. Since 2001 more than 500,000 children and families have received services in Burkina Faso, India, Malawi, Romania and Tanzania.

Support to help prevent mother-to-child transmission of HIV - The transmission of HIV from mother to child has been virtually eliminated in the United States, but remains a significant problem in developing countries. Testing is the first step toward achieving prevention, and Abbott is donating rapid HIV tests to programs for the prevention of mother-to-child transmission of HIV in Africa and the LDCs. To date, Abbott has provided more than 3.4 million free HIV tests through the program.

Additional Abbott Program Results in Developing Countries
In addition to child-focused programs, Abbott and the Abbott Fund are addressing fundamental barriers to testing, treatment and support services for people living with HIV; results to date include:

Provided 42 million rapid HIV tests at no profit to Africa and the LDCs to expand access to testing services;

Trained more than 15,000 health care workers in developing countries; and

Implemented a nationwide program to scale-up testing and treatment in Tanzania; this includes an outpatient center and modern clinical laboratories at Muhimbili National Hospital serving up to 1,000 patients a day, and the expansion of testing and treatment services at 82 hospitals and health centers across the country.

Lopinavir/Ritonavir Indication and Safety Information
Lopinavir/ritonavir is always used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. Lopinavir/ritonavir is a combination of two medicines. They are lopinavir and ritonavir. Lopinavir/ritonavir is a type of medicine called an HIV protease (PRO-tee-ase) inhibitor. Lopinavir/ritonavir is for adults and for children age six months and older.

Once-daily dosing of lopinavir/ritonavir in combination with other anti-HIV medicines is not recommended for people with previous HIV treatment and has not been evaluated in children.

Important Safety Information
Lopinavir/ritonavir does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others.

Lopinavir/ritonavir should not be taken by people who have had an allergic reaction to lopinavir/ritonavir or any of its ingredients, including lopinavir or ritonavir.

Taking lopinavir/ritonavir with certain drugs can cause serious problems or death. Lopinavir/ritonavir should not be taken with dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot(R), Migranal(R), D.H.E. 45(R), Ergotrate Maleate, and Methergine, as well as Halcion(R), Hismanal(R), Orap(R), Propulsid(R), Seldane(R) or Versed(R).

Lopinavir/ritonavir should also not be taken with rifampin, also known as Rimactane(R), Rifadin(R), Rifater(R), or Rifamate(R), Flonase(R), Mevacor(R), Zocor(R) or products containing St. John's wort (Hypericum perforatum). Once-daily Lopinavir/ritonavir should not be taken with Agenerase(R), Sustiva(R), Viracept(R), Viramune(R), Dilantin(R), Phenobarbital or Tegretol(R).

Particular caution should be used when taking Viagra, Cialis or Levitra, since the interaction with lopinavir/ritonavir may result in an increase in their related side effects. Patients should discuss all medicines, including those without a prescription and herbal products that they are taking or plan to take, with their doctor or pharmacist.

Pancreatitis and liver problems, which can be fatal, have been reported in patients receiving lopinavir/ritonavir. Patients should tell their doctor if they have nausea, vomiting, or abdominal pain, which may be signs of pancreatitis, or if they have or have had liver disease such as hepatitis B or C. In patients taking protease inhibitors, increased bleeding (in patients with hemophilia) and diabetes/high blood sugar have occurred.

Changes in body fat have been seen in some patients receiving anti-retroviral therapy. The cause and long-term health effects of these conditions are not known at this time. Some patients receiving lopinavir/ritonavir have had large increases in triglycerides and cholesterol. Varying degrees of cross-resistance among protease inhibitors have been observed.

The most commonly reported side effects of moderate severity are: abdominal pain, abnormal bowel movements, diarrhea, feeling weak or tired, headache, and nausea. Children taking lopinavir/ritonavir may sometimes get a skin rash. This is not a complete list of reported side effects.

Diarrhea may be more common in patients taking lopinavir/ritonavir capsules once-daily compared to the twice-daily dose (57 percent vs. 35 percent of mild to severe events and possibly related to the drug; and 16 percent vs. 5 percent of at least moderate severity and possibly related to the drug as found in a clinical study). Lopinavir/ritonavir oral solution contains alcohol. Exposure of this product to high humidity outside the original container for longer than two weeks is not recommended.

For more information, including full prescribing information, please visit www.kaletra.com.

About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 60,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at www.abbott.com.

Abbott

About Abbott and the Abbott Fund

The Abbott Fund is a philanthropic foundation established by Abbott in 1951. The Abbott Fund's mission is to create healthier global communities by investing in creative ideas that promote science, expand access to health care and strengthen communities worldwide. For more information, visit www.abbottfund.org.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's website at www.abbott.com.

Abbott Statement on Advancing Pediatric HIV Treatment in Developing Countries

Abbott Statement on Advancing Pediatric HIV Treatment in Developing Countries

Abbott

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