Merck & Co., Inc. announced that it has begun to file registrations for ATRIPLA? (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), a once-daily, single tablet regimen for the treatment of HIV-1 infection in adults, with health authorities in those developing countries around the world where many HIV-positive people live.
Merck began to file registrations for ATRIPLA in November 2006 (beginning with Ethiopia). ATRIPLA will be filed in 45 countries in the Middle East & Africa and an additional nine countries in Latin America, the Caribbean and Asia Pacific through the first half of 2007. Its availability to patients in these countries will depend on the pace of national regulatory processes. In an additional 11 countries, ATRIPLA can be imported based on the U.S. registration. Merck is also pursuing an application for WHO pre-qualification.
“This new single-tablet regimen, which can simplify HIV treatment for people living with HIV infection, exemplifies our mission of putting patients first,” said Merck Chief Executive Officer and President Richard T. Clark. “Merck has long been a leader in efforts to broaden access to medicines and vaccines around the world. We look forward to collaborating with Gilead and national health authorities to deliver ATRIPLA to those who need it most as quickly as possible.”
“Fixed dose combination drugs (FDCs) have revolutionized antiretroviral therapy in the developing world and brought treatment to millions,” said Professor Sir Richard G. A. Feachem, Executive Director, The Global Fund to Fight AIDS, TB and Malaria. “ATRIPLA is a valuable addition to the FDC armory and requires only one pill per day. It is also the first triple drug FDC for HIV/AIDS developed by a consortium of originator companies. Merck and Gilead are to be congratulated on bringing to the market this new weapon in the fight against HIV/AIDS in developing countries.”
ATRIPLA pricing in developing countries
For countries in the Low Human Development Index (HDI) category and countries in the Medium HDI category, with adult HIV prevalence of 1% or greater, ATRIPLA will be available to all purchasers at a price of US $1.68 per tablet, or US $50.40 per pack (ex-manufacturer). Sixty-seven countries are eligible for this pricing. For countries in the Medium HDI with adult HIV prevalence of less than 1%, ATRIPLA will be available to all purchasers at a price of US $2.83, or US $84.90 per pack (ex-manufacturer). Twenty-two countries are in this category.