The Gilead Access Program makes Gilead’s Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Viread(R) (tenofovir disoproxil fumarate) available to physicians and treatment programs in countries at the no-profit prices of US$29.75 per month (US$0.99 per day) and US$24.71 per month (US$0.82 per day), respectively.
Gilead’s global Access Program was initiated in April 2003 and originally served 68 countries, including every country in Africa and 15 additional countries classified as “least developed” by the United Nations. Today’s expansion means that 95 countries, representing an estimated 70 percent of the global epidemic, are now included in the company’s access effort.
The expansion focuses largely on the Caribbean region, which is second only to Sub-Saharan Africa in prevalence of HIV. With this expansion, the lowest income countries in the Caribbean have access to Gilead antiretrovirals at no-profit prices. In addition, the program has been expanded to include the low-income Latin American countries of Bolivia, Guatemala, Guyana, Honduras and Nicaragua.
Gilead also announced the recent establishment of a facility in The Bahamas to manufacture tenofovir disoproxil fumarate (tenofovir DF), the active drug substance in Viread, through a cooperative effort between PharmaChem Technologies, Gilead Sciences and the Grand Bahama Port Authority. This plant has been designed for the cost-effective production of tenofovir DF, with enough initial manufacturing capacity to provide treatment for 500,000 people annually. Over time, that capacity may be increased to allow for treatment of up to 1 million people per year, including patients both in resource-limited parts of the world and in the developed world. The new plant complies with current U.S. Food and Drug Administration standards for Good Manufacturing Practices (GMPs).
“These announcements are milestones in our region’s fight against AIDS,” said The Honorable Perry Gladstone Christie, Prime Minister of The Bahamas. “The Caribbean has experienced a substantial HIV epidemic, and the countries of this region are too often overlooked in AIDS relief efforts. The need for effective drugs to treat HIV infection around the world is large and growing, and this new facility in The Bahamas will produce one of the leading drugs used to combat the virus. Together with the people of The Bahamas, I commend Gilead Sciences for making two important HIV medications more easily accessible for people living with HIV/AIDS in the Caribbean and beyond.”
“As a company that focuses on developing therapeutic advancements for the treatment of infectious diseases, we understand the overwhelming need for broad global access to effective HIV medications,” said John C. Martin, PhD, President and Chief Executive Officer of Gilead Sciences. “This need is particularly acute for individuals living with HIV/AIDS in the countries of the Caribbean and Latin America. We believe that through partnership with governments, healthcare providers and non-governmental organizations, we can make progress toward ensuring those who need our products receive them at the lowest possible price.”
The parent compound of Viread, tenofovir, was discovered through a collaborative research effort between Dr. Antonin Holy, Institute for Organic Chemistry and Biochemistry, Academy of Sciences of the Czech Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for Medical Research, Katholic University in Leuven, Belgium. Emtriva(R) (emtricitabine), one of the components of Truvada, was discovered by Dr. Raymond F. Schinazi, Dr. Dennis C. Liotta and Dr. Woo-Baeg Choi and licensed to Gilead by Emory University in 1996. Emory University and the inventors of both Viread and Emtriva, the components in Truvada, have agreed to waive their right to a royalty on sales of Truvada in the Gilead Access Program countries to ensure the product can be offered at a no-profit price in parts of the world where the epidemic has hit the hardest.
It is important that patients be aware that HIV medications must be taken as part of combination regimens and that they do not cure HIV infection, nor do they reduce its transmission.
