Press Release: President Clinton Announces Breakthroughs in HIV/AIDS Treatment for Children

Clinton Foundation to Lead $50 Million Effort with UNITAID to Assist 40 Countries to Expand Treatment to 100,000 Additional Children in 2007.

President Bill Clinton announced today that his foundation has negotiated new agreements to lower the price of HIV/AIDS treatment for children.

Cipla and Ranbaxy will price a new child-friendly product — a three-in-one dispersible tablet that replaces individual solutions which need refrigeration — for less than $60 per year, or 16 cents per day, for an average child (weighing 10kg). Thanks to additional commitments by Cipla and other suppliers, the new agreements will supply a total of 19 different pediatric antiretroviral (ARV) formulations for prices that are, on average, 45 percent less than the lowest rates available today in low-income countries. The new prices will be available to the foundation’s Procurement Consortium, which currently includes 62 developing countries in Africa, Asia, Latin America and the Caribbean, together representing more than 90 percent of people living with HIV/AIDS in developing countries.

The new prices have been made possible by UNITAID, the international drug purchase facility established in September by France, Brazil, Chile, Norway and the UK. UNITAID will provide the Clinton Foundation HIV/AIDS Initiative (CHAI) with $35 million in the next year to buy medicines and diagnostics, and CHAI will contribute $15 million more for technical assistance, to work with 40 countries to treat more than 100,000 additional HIV-positive children in 2007.

“Though the world has made progress in expanding HIV/AIDS treatment to adults, children have been left behind. Only one in 10 children who needs treatment is getting it,” said President Clinton. “I applaud the commitments that Cipla, Ranbaxy and others have made to lower the price of the drugs we need to treat children, and I thank UNITAID for the new funds that have made these prices possible.”

French Foreign Minister Philippe Douste-Blazy, chairman of the UNITAID board, added, “No child should have to live with HIV, but every one who does deserves a full life. Pediatric drugs should be affordable and easy to administer. That has been an early goal of UNITAID, and we are pleased that our partnership with President Clinton will now make this possible.”

President Clinton and Minister Douste-Blazy made today’s announcement at the Kalawati Saran Children’s Hospital in New Delhi, where they joined Sonia Gandhi to launch the Government of India’s national program to treat HIV-positive children. The program aims to increase the number of children on treatment — from less than 2,000 in September to 10,000 by the end of March — by making pediatric care available at all adult treatment centers in the country. These children will be initiated on treatment with medicines procured with resources from UNITAID. CHAI is supporting the Indian National AIDS Control Organization to implement the program.

Cipla and Ranbaxy’s pediatric fixed-dose combination (FDC) tablets include three ARVs — lamivudine, stavudine and nevirapine — used commonly for first-line treatment. These FDCs can be split in half and dissolve fully in water, making them suitable for use even in young children. The dosing of these FDCs, depends on the patient’s weight, and according to the dosing recommended by the companies, the average price from the two companies for a child weighing 10kg is less than $60. The World Health Organization (WHO) is developing international guidelines on pediatric FDC dosing which may be different to those that are recommended by the manufacturers. Cipla and Ranbaxy are committed to adapting their products as necessary to comply with these guidelines, when finalized.

In total, CHAI will use funds from UNITAID to purchase 10 ARVs in 21 different pediatric formulations. The reduced prices announced today for 19 of these formulations reflect partnerships between CHAI and Cipla and Ranbaxy as well as commercial agreements with other manufacturers. In response to an open invitation issued to 14 manufacturers, Cipla and Ranbaxy agreed to supply pediatric formulations for deeply discounted prices. CHAI also expects to purchase ARVs from Abbott, Aurobindo, Bristol Myers Squibb, Merck, Roche and others, based on responses to its invitation and the needs of partner governments.

In addition to the three ARVs included in the pediatric FDC, the other ARVs for which CHAI has negotiated price reductions include abacavir, didanosine, efavirenz and zidovudine. The 45% average price reduction for the 19 formulations of these drugs is based on a comparison of the newly agreed prices to the lowest prices previously available to low-income countries from generic or originator companies. The prices under the new agreements will represent even larger reductions — more than 70%, on average — compared to current prices being paid by middle income countries in regions such as Latin America and South East Asia.

CHAI will also use UNITAID funds to supply laboratory instruments and tests for HIV/AIDS diagnosis and monitoring, including rapid tests, CD4 tests and, for infant diagnosis, DNA PCR and RNA PCR. CHAI will also supply the antibiotic cotrimoxazole and ready-to-use therapeutic food (RUTF). Studies show that the preventative daily use of half a tablet of cotrimoxazole can reduce HIV-related mortality in young children by more than a third. RUTF is used to treat severe and acute malnutrition; it also helps to improve the response to treatment and to reduce toxicities associated with ARV use.

CHAI is partnering with 40 governments to supply these products with UNITAID support. In addition, CHAI and its partner governments will depend on the contributions of other technical and funding partners, including UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). In addition to pediatric treatment, prevention of mother to child transmission of HIV is a priority in the fight against AIDS. CHAI supports programs that offer a combined approach that links prevention of pediatric HIV infection to treatment and care for both parents and children.

CHAI is committed to providing high-quality products under its agreements with manufacturers. The products included in today’s agreements meet the quality assurance standards of the Global Fund, which prioritize prequalification by the WHO and/or approval by the U.S. Food and Drug Administration (FDA) or other stringent regulatory authority. Twelve of the 19 formulations included in the agreements being announced today have been approved by the WHO and/or FDA for one or more supplier(s). The remaining products have been submitted for review. These submissions include data from bioequivalence testing conducted by research laboratories that have been successfully audited by the WHO and/or FDA. CHAI will only be purchasing ARVs that are eligible according to the quality assurance standards of the Global Fund, standards that UNITAID has also adopted.

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