Merck/Gilead once-a-day AIDS pill not available in most places

AIDS Healthcare Foundation (AHF) today called on Gilead Sciences and Merck to immediately register and distribute the three-in-one, once daily lifesaving HIV treatment, Atripla, in developing countries.

When Atripla first received approval from the Food and Drug Administration (FDA) in July of 2006, advocates like AHF applauded the production of a single, once-a-day drug as a landmark step in treating HIV. However, since its approval, little progress has been made in expanding the availability of the treatment in the developing world, where only 28% of those in need of treatment were able to access it as of December 2006. Efforts made by AHF to clarify what countries currently can purchase Atripla at the announced $613 per patient per year access price have gone unanswered.

"This treatment is a standard therapy in the United States. It is on the World Health Organization's Essential Medicines List, and is an antiretroviral drug regimen that could greatly benefit patients everywhere while reducing costs in the long term," said Michael Weinstein, AIDS Healthcare Foundation President. "The fact that Gilead and Merck appear to be unable or unwilling to make it available in resource-poor countries is deeply troubling, and causing unnecessary suffering. Gilead and Merck should immediately begin making this treatment available to the rest of the world, or license it out to a generic drug manufacturer, such as Cipla, which already produces a generic version in India, that will. In the instances where the registration process has been initiated such as in the European Union, governments must also recognize their roles and streamline the necessary approval processes to facilitate quick distribution of these lifesaving drugs."

The key value of an all-in-one, one pill per day HIV treatment regimen is the reduced pill burden required for patients. Currently, the most widely used regimen for treatment naive patients consists of a combination of at least two pills taken twice per day, often required to be taken with food and during mid-day hours. Atripla, however, only requires a single pill to be taken once daily without food before bed.

"As we have seen in many of our clinics, pill burden and side effects can be challenging for patients to become accustomed to, and they are among the primary reasons patients do not follow their treatment regimens," said Dr. Homayoon Khanlou, AIDS Healthcare Foundation's Chief of Medicine. "With a complete daily treatment regimen in one pill, the advantage goes much further than simply fewer pills and fewer side effects. The ease of treatment results in improved adherence with more patients taking their medication as prescribed, which greatly increases the effectiveness of treatment. This also results in fewer patients developing resistance to the drugs, and from having to move on to more expensive second-line drugs."