Activists meet with Gilead and Abbott over access to second-line therapy

HIV Treat Bull - Vol. 7, No. 7/8, July/August 2006

On 13-14 July, 25 activists from Africa, Asia, Latin America, the Caribbean, Eastern and Western Europe and the United States, met in London with two companies whose AIDS drugs are crucial in second-line regimens. Currently, patients in most developing countries and in many middle income countries have no treatment options if their first regimen fails due to resistance or side effects, because of the cost of second-line medicines.

Gilead Sciences of Foster City, California manufactures tenofovir, which works against strains of the virus resistant to first-generation nucleoside reverse transcriptase inhibitors like AZT and 3TC. Abbott Laboratories of Abbott Park, Illinois, makes two drugs, ritonavir and lopinavir, which are sold in combination under the trade name Kaletra. Ritonavir alone also has a crucial role in boosting the effectiveness of other protease inhibitors made by other manufacturers. Both drugs have been available for several years to HIV-positive people in Western Europe, North America and elsewhere in the developed world.

However, while approximately 1.3-1.5 million people in developing countries are now on first-line antiretroviral treatment, which costs from approximately $135 a year upwards, the least expensive second-line regimen costs upwards of $500 a year. Most countries are struggling to scale-up access to first line regimens for those who need them and the cost of second-line regimens will make these agents simply out-of-reach for most public sector programs, threatening the survival of those people who are resistant to, or who cannot tolerate, first-line treatment.

Key issues raised with both companies included:

• The patent status of their drugs in developing countries with capacity to manufacturer for domestic use or for export and the vital importance of generic competition in ensuring affordable medicines;
• The importance of voluntary licenses that enable generic companies to manufacture their drugs. While Gilead is in negotiation with 5-7 generic companies in India to produce tenofovir, Abbott refuses to grant any voluntary licenses to generic producers to make Kaletra;
• Pricing of drugs from the brand-name companies in lower and upper middle-income countries that are not able to benefit from lowest prices offered to least-developed countries (LDCs). Prices in many middle-income countries are currently unaffordable;
• Importance of affordable second-line therapy – at or near the cost of first-line treatment;
• The need for research and development on lower cost options for second-line therapy;
• Coordination of industry policies on pricing for low, low middle and upper middle income countries (e.g. Abbott offers preferential pricing to 67 “low” income countries while Gilead offers this discount to 97 countries).

Activists will continue to push their concerns with Gilead and Abbott and other drug companies and raise these issues with UN agencies and their own ministries of health and make it a central issue for advocacy at the upcoming International AIDS Conference in Toronto in August 2006.

World CAB is a project of the International Treatment Preparedness Coalition, a network of over 700 people from over 100 countries around the world. There have been three World CAB meetings - the first with Roche, BI, and GSK in 2004 in San Francisco; the second with generic ART producers in 2005 in Mumbai, and this meeting Gilead and Abbott in July 2006. ITPC has an international steering group of about 30 people from around the world and each region has its own leadership structure, which selects advocates to attend the World CAB meetings. Delegates form this meeting came from Peru, Paraguay, El Salvador, Estonia, Croatia, Ukraine, Russia, Moldova, Zambia, Uganda, South Africa, Cameroon, Morocco, China, India, Suriname.

Source: ITPC press release

Reports from World CAB meetings and other ITPC documents are available

2008-03-10
IB060707-22

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