Two Indian companies are to supply antiretroviral treatment for children in developing countries at an annual price of around $60 a year, former President Bill Clinton announced today in Delhi, launching a 62 country programme to be funded by the international drug purchase facility UNITAID and his foundation.
The two companies, Cipla and Ranbaxy, will supply 19 antiretroviral products for children.
UNITAID will provide US$35 million and the Clinton Foundation HIV/AIDS Initiative will contribute US$15 million, which is projected to provide treatment for 100,000 HIV-positive children in 62 countries in 2007.
The Clinton HIV/AIDS Initiative (CHAI) has been contracted by UNITAID to source antiretroviral products for paediatric and second-line treatment and to negotiate reduced prices with Indian manufacturers.
A number of Indian companies are developing fixed dose triple combinations for children that contain appropriate doses of each drug, and two products, Pedimune from Cipla, and Triviro-LNS kid from Ranbaxy, are awaiting World Health Organization prequalification, which would permit widespread international use.
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.
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.
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.