
Washington Post (07.13.06) - Thursday, July 13, 2006
Marc Kaufman
"This is a landmark for those suffering with HIV and AIDS," said Andrew von Eschenbach, acting FDA commissioner. Noting that "compliance with therapy is as important as the therapy itself for a successful outcome," he said the single-dose medication, called Atripla, will likely help patients improve adherence. This, in turn, will help slow the development of community-wide resistance to AIDS drugs. "A single, fixed-dose pill has long been seen as the holy grail of AIDS treatment," said Murray Lumpkin, deputy FDA commissioner.
Atripla combines the two most-prescribed AIDS medications: Bristol Myers Squibb Co.'s Sustiva and Gilead Science's Truvada. The latter drug is itself a combination of two other Gilead treatments: Viread and Emtriva. Gilead said Atripla will cost about $1,100 per month, equivalent to the separate costs of Sustiva and Truvada. But the fact that Gilead will make the pill salmon-colored for US distribution and white for sale elsewhere suggests the two versions will be priced quite differently. Merck & Co. will set the price of Atripla in developing countries, where it markets Sustiva as Stocrin. Atripla will be manufactured in Canada.
John C. Martin, CEO of Gilead, said creating the single-pill version of the drugs was difficult: Five potential formulations failed before the successful one was found. "This is not simply a matter of putting together the three drugs. They have to be put together in a way that each reacts as it does when it's alone, and that can get complicated."
"We know that an HIV/AIDS patient needs to take 95 percent of his or her pills or they won't work," Martin said. "So the fewer pills a patient needs to take, the better the outcome."
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