Deal lowers price of second-line therapy and makes new paediatric formulations available to poorer countries

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Further reductions in the prices of generic versions of key second-line antiretroviral drugs were announced yesterday, thanks to an agreement negotiated by the international drug purchase fund UNITAID and the Clinton HIV/AIDS Initiative with Indian and Chinese generic drug manufacturers.

Under the deal the cost of tenofovir, 3TC (lamivudine) and lopinavir/ritonavir will fall by almost a fifth compared to prices a year ago.

Six new, easy to take child-friendly antiretroviral formulations will also be made available by the deal, and a paediatric fixed-dose combination of AZT, 3TC and nevirapine will cost no more than $66 per year.

Glossary

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

second-line treatment

The second preferred therapy for a particular condition, used after first-line treatment fails or if a person cannot tolerate first-line drugs.

low income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. While the majority of the approximately 30 countries that are ranked as low income are in sub-Saharan Africa, many African countries including Kenya, Nigeria, South Africa and Zambia are in the middle-income brackets. 

paediatric

Of or relating to children.

fixed-dose combination (FDC)

Two or more drugs contained in a single dosage form, such as a capsule or tablet. By reducing the number of pills a person must take each day, fixed-dose combination drugs may help improve adherence.

The cost cutting will mean that tenofovir, 3TC and lopinavir/ritonavir, the most widely used second-line generic combination, will be available to low income countries at an average of 16% less than the current average market price and to middle-income countries at prices that are 46% lower.

A year of treatment with a generic version of lopinavir/ritonavir will now cost between $613 – $550, with fixed-dose tenofovir and 3TC costing $159 a year. It is estimated that 500,000 patients in low-income countries will require second-line therapy by 2010. Abbott, the originator of lopinavir/ritonavir, charges $500 for its heat-stable version, Aluvia, in least-developed countries and $1000 in lower middle-income countries.

The deal will also reduce the price of generic versions of tenofovir/FTC, tenofovir/3TC and tenofovir/3TC/efavirenz fixed dose combinations; the tenofovir/3TC/efavirenz product manufactured by Matrix Laboratories will cost $299 a year, compared to $100 a year for d4T/3TC/nevirapine and $159 for AZT/3TC/nevirapine. Some countries, such as Zambia, have already switched from d4T to tenofovir-based regimens for first-line treatment because they are less toxic, but others have opted to stick with d4T or AZT-based regimens in order to treat more people.

“Today’s announcement is an important step in helping to save the millions of children and adults infected with HIV in the developing world who still lack access to life-saving drugs”, said former US President Bill Clinton.

Due to an agreement with the generic manufacturer, Matrix Laboratories, a paediatric fixed-dose formulation of AZT, 3TC and nevirapine will be available at a cost of no more than $66 per year. AZT-based therapy involves significantly fewer side-effects than treatment that includes d4T.

Other generic manufacturers involved in the deal are Aurobindo Pharma and Cipla.

The prices of over 40 antiretrovirals are affected by the latest deal. Compared to the latest figures from Medecins Sans Frontieres, the UNITAID/Clinton Foundation prices are an average of 21% lower.

Over 200,000 HIV-positive adults and children in poorer countries are receiving antiretrovirals with UNITAID support, and globally the partnership between UNITAID and the Clinton Foundation is supporting two-thirds of children in receipt of antiretroviral therapy. According to the Clinton HIV/AIDS Initiative, around 1.4 million adults and children are now benefiting from antiretroviral drugs purchased at prices negotiated by the CHAI Procurement Consortium.

“This achievement represents a major step in our partnership to provide more treatments to hundreds of thousands of children through 2010 and to continue to lower the price of second-line treatment”, said Philippe Douste-Blazy of UNITAID.