Clinton Foundation announces breakthroughs in pediatric HIV/AIDS treatment

New agreements lower the price of 19 pediatric antiretroviral formulations by 45% for 62 countries.

The Bill Clinton Foundation has negotiated several new agreements to reduce the price of antiretroviral drugs for children with HIV/AIDS and provide them with the treatment and care they urgently need.

Cipla Pharmaceuticals and Ranbaxy Laboratories Limited plan to price a new child-friendly product, a three-in-one tablet that replaces individual solutions, for less than $60 per year, or 16 cents per day, per child.

Additional commitments by Cipla and other suppliers are in the works to supply 19 different pediatric antiretroviral formulations for prices that are, on average, 45% 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, these countries represent more than 90% of people living with HIV/AIDS in developing countries.

UNITAID, the international drug purchase facility established last September by France, Brazil, Chile, Norway and the United Kingdom, plans to provide the Clinton Foundation HIV/AIDS Initiative (CHAI) with $35 million to purchase these medicines and diagnostics. In turn, CHAI has raised $15 million more for technical assistance to work with 40 countries during 2007 and also treat more than 100,000 children living with HIV.

Only about 80,000 of the 660,000 children living with HIV/AIDS currently receive treatment, according to a press release.

“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,” Clinton said in the press release. “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.”

Reducing costs

Clinton and French Foreign Minister Philippe Douste-Blazy made the announcement of this new initiative 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 children with HIV. This 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 India. These children will begin treatment with medicines procured with resources from UNITAID. CHAI is supporting the Indian National AIDS Control Organization to implement the program.

In total, CHAI will use funds from UNITAID to purchase 10 antiretroviral drugs in 21 different pediatric formulations.

Cipla and Ranbaxy’s pediatric fixed-dose combination tablets include three antiretroviral drugs: lamivudine (Epivir, GlaxoSmithKline), stavudine (Zerit, Bristol-Myers Squibb) and nevirapine (Viramune, Boehringer Ingelheim). This fixed-dose combination needs no refrigeration, which is an advantage in underdeveloped countries lacking electricity, and it can be split in half and dissolvd fully in water, making them suitable for use even in children too young to swallow pills. The dosing depends on the child’s weight.

“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,” said Douste-Blazy, chairman of the UNITAID board.

WHO is developing international guidelines on pediatric fixed-dose combination tablets dosing, which may be different to those that are recommended by the manufacturers. Cipla and Ranbaxy will adapt their products as necessary to comply with these guidelines, when finalized.

The reduced prices announced 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 discounted prices. CHAI also expects to purchase antiretroviral drugs from pharmaceutical companies such as Abbott, Aurobindo, Bristol-Myers Squibb, Merck, Roche and others. Other drugs for which CHAI has negotiated price reductions include abacavir (Ziagen, GlaxoSmithKline), didanosine (Videx, Bristol-Myers Squib), efavirenz (Sustiva, Bristol-Myers Squibb) and zidovudine (Retrovir, GlaxoSmithKline).

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 with current prices being paid by middle-income countries in regions such as Latin America and Southeast Asia.

The products included in the agreements meet the quality assurance standards of the Global Fund, which prioritizes prequalification by WHO, and/or approval by the FDA or other stringent regulatory authority. Twelve of the 19 formulations included in the agreements are approved by WHO and/or the FDA for one or more supplier. 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 WHO and/or the FDA. CHAI will only purchase antiretroviral drugs that are eligible according to the quality assurance standards of the Global Fund, standards that UNITAID has also adopted.

Additional agreements made

In addition to pediatric treatment, prevention of maternal-fetal 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 to treatment and care for both parents and children.

Under this new agreement, 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 polymerase chain reaction and RNA polymerase chain reaction.

CHAI will supply cotrimoxazole and food. Studies showed that the preventive daily use of half a tablet of cotrimoxazole can reduce HIV-related mortality in young children by more than one-third. The supply of food will help to improve the response to treatment and will reduce antiretroviral drug-associated toxicities. CHAI is partnering with 40 governments to supply these products with UNITAID support.

CHAI and its partner governments will depend on the contributions of other technical and funding partners, including United Nation’s Children’s Fund, the Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S. President’s Emergency Plan for AIDS Relief. – by Tara Grassia

The Bill Clinton Foundation has negotiated several new agreements to reduce the price of antiretroviral drugs for children with HIV/AIDS and provide them with the treatment and care they urgently need.

Cipla Pharmaceuticals and Ranbaxy Laboratories Limited plan to price a new child-friendly product, a three-in-one tablet that replaces individual solutions, for less than $60 per year, or 16 cents per day, per child.

Additional commitments by Cipla and other suppliers are in the works to supply 19 different pediatric antiretroviral formulations for prices that are, on average, 45% 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, these countries represent more than 90% of people living with HIV/AIDS in developing countries.

UNITAID, the international drug purchase facility established last September by France, Brazil, Chile, Norway and the United Kingdom, plans to provide the Clinton Foundation HIV/AIDS Initiative (CHAI) with $35 million to purchase these medicines and diagnostics. In turn, CHAI has raised $15 million more for technical assistance to work with 40 countries during 2007 and also treat more than 100,000 children living with HIV.

Only about 80,000 of the 660,000 children living with HIV/AIDS currently receive treatment, according to a press release.

“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,” Clinton said in the press release. “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.”

Reducing costs

Clinton and French Foreign Minister Philippe Douste-Blazy made the announcement of this new initiative 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 children with HIV. This 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 India. These children will begin treatment with medicines procured with resources from UNITAID. CHAI is supporting the Indian National AIDS Control Organization to implement the program.

In total, CHAI will use funds from UNITAID to purchase 10 antiretroviral drugs in 21 different pediatric formulations.

Cipla and Ranbaxy’s pediatric fixed-dose combination tablets include three antiretroviral drugs: lamivudine (Epivir, GlaxoSmithKline), stavudine (Zerit, Bristol-Myers Squibb) and nevirapine (Viramune, Boehringer Ingelheim). This fixed-dose combination needs no refrigeration, which is an advantage in underdeveloped countries lacking electricity, and it can be split in half and dissolvd fully in water, making them suitable for use even in children too young to swallow pills. The dosing depends on the child’s weight.

“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,” said Douste-Blazy, chairman of the UNITAID board.

WHO is developing international guidelines on pediatric fixed-dose combination tablets dosing, which may be different to those that are recommended by the manufacturers. Cipla and Ranbaxy will adapt their products as necessary to comply with these guidelines, when finalized.

The reduced prices announced 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 discounted prices. CHAI also expects to purchase antiretroviral drugs from pharmaceutical companies such as Abbott, Aurobindo, Bristol-Myers Squibb, Merck, Roche and others. Other drugs for which CHAI has negotiated price reductions include abacavir (Ziagen, GlaxoSmithKline), didanosine (Videx, Bristol-Myers Squib), efavirenz (Sustiva, Bristol-Myers Squibb) and zidovudine (Retrovir, GlaxoSmithKline).

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 with current prices being paid by middle-income countries in regions such as Latin America and Southeast Asia.

The products included in the agreements meet the quality assurance standards of the Global Fund, which prioritizes prequalification by WHO, and/or approval by the FDA or other stringent regulatory authority. Twelve of the 19 formulations included in the agreements are approved by WHO and/or the FDA for one or more supplier. 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 WHO and/or the FDA. CHAI will only purchase antiretroviral drugs that are eligible according to the quality assurance standards of the Global Fund, standards that UNITAID has also adopted.

Additional agreements made

In addition to pediatric treatment, prevention of maternal-fetal 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 to treatment and care for both parents and children.

Under this new agreement, 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 polymerase chain reaction and RNA polymerase chain reaction.

CHAI will supply cotrimoxazole and food. Studies showed that the preventive daily use of half a tablet of cotrimoxazole can reduce HIV-related mortality in young children by more than one-third. The supply of food will help to improve the response to treatment and will reduce antiretroviral drug-associated toxicities. CHAI is partnering with 40 governments to supply these products with UNITAID support.

CHAI and its partner governments will depend on the contributions of other technical and funding partners, including United Nation’s Children’s Fund, the Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S. President’s Emergency Plan for AIDS Relief. – by Tara Grassia