Single Tablet per Day: Atripla Fixed-Dose Combination

Partnership Objectives

  1. Reduce impact on the disease in resource-limited settings by using combinations of different ARVs to treat people living with HIV/AIDS.
  2. Reduce the risk of people living with HIV/AIDS developing resistance.

This program increases access to Atripla®, the first once-daily single tablet regimen for the treatment of HIV infection in adults. This program increases access to Atripla®, the first once-daily single tablet regimen for the treatment of HIV infection in adults. Copyright BMS

What are the health needs and challenges?

Many patients face increasing treatment resistance and the risk of treatment failure. Combinations of ARVs are used to treat people living with HIV/AIDS to reduce the risk of them developing resistance. Atripla® - the first once-daily single tablet regimen for the treatment of HIV infection in adults - is a fixed-dose combination of the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz and the nucleoside reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate. Efavirenz is marketed by Bristol-Myers Squibb as Sustiva® and by MSD as Stocrin®. Emtricitabine and tenofovir disoproxil fumarate are commercialized by Gilead Sciences under the tradenames Emtriva® and Viread®.

Description of partnership activities and how they address needs and challenges

This program increases access to Atripla®, the first once-daily single tablet regimen for the treatment of HIV infection in adults. It is a fixed-dose combination of the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz, and the nucleoside reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate.

Efavirenz is marketed by Bristol-Myers Squibb as Sustiva® and by MSD as Stocrin®. Emtricitabine and tenofovir disoproxil fumarate are commercialized by Gilead Sciences under the tradenames Emtriva® and Viread®. Atripla® was developed by Bristol-Myers Squibb and Gilead and approved by the US FDA in July 2006, Health Canada in October 2007 and the European Commission in December 2007. On January 15, 2008, the WHO granted Atripla® prequalification status.

In August 2006, Gilead and MSD announced an agreement for the distribution of Atripla® in 106 developing countries around the world where convenient treatment options are critical to patient compliance and adherence to therapy. Gilead is manufacturing Atripla® using efavirenz supplied by MSD, and MSD is distributing Atripla® in these markets.

In all of these countries, Atripla® is sold at significantly discounted prices. At least 55 countries – including most in sub-Saharan Africa – had either granted regulatory approval for Atripla® or allowed the product to be imported.

Summary of impact and forward looking information

Tens of thousands of patients are benefitting from this first-of-its-kind fixed-dose combination ARV.

Partnership information

Company(ies) Bristol-Myers Squibb , MSD

Partner(s) Gilead Sciences

Type of Partner(s) PDPs

Therapeutic Focus Infectious Diseases

Disease(s) HIV/AIDS

Program Type(s) Availability of Treatment - Differential Pricing

Targeted Population(s) Men, Patients in needs of treatment, People with low income, Women

Region(s) East Asia & Pacific, Sub-Saharan Africa

Number of Countries 64

Country(ies) Angola, Benin, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, China, Comoros, Congo, Côte d'Ivoire, Democratic Republic of the Congo, Eritrea, Ethiopia, Fiji, Gabon, Ghana, Guinea, Guinea-Bissau, Indonesia, Kenya, Kiribati, Lesotho, Liberia, Madagascar, Malawi, Malaysia, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Mongolia, Mozambique, Namibia, Niger, Nigeria, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Korea, Sudan, Swaziland, Tanzania, Thailand, The Gambia, Timor-Leste, Togo, Tonga, Tuvalu, Uganda, Vanuatu, Vietnam, Zambia, Zimbabwe

Start Date 2006

Anticipated completion date Ongoing