Approval came quickly for unusual case of corporate collaboration
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The first complete treatment for AIDS taken once a day as a single pill should become available soon.
The U.S. Food and Drug Administration on Wednesday gave its approval to the new drug a combination of Sustiva, marketed by Bristol-Myers Squibb, and Truvada, sold by Gilead Sciences.
Although not the first pill combining more than one drug to fight AIDS indeed, Truvada is a combination of two Gilead drugs, Emtriva and Viread this will be the first using drugs from two companies.
Although the FDA had until October to act, it acted much sooner, in part because the government has been encouraging companies to collaborate with the goal of devising with simpler AIDS drugs.
“Going down to one pill a day is amazing,” Keith Folger of Washington, director of community mobilization for the National Association of People with AIDS, told the New York Times. Folger said he started on 36 pills a day about 11 years ago. He expects to switch to the new pill as soon as it becomes available.
The companies have not revealed the new drug’s name or its price. But they have suggested that it will cost about the same as Sustiva and Truvada purchased separately, which is about $1,200 a month.
The drugs in the new pill constitute the most widely prescribed regimen against AIDS in the United States, and one of the most effective. Doctors expect most people now taking Sustiva and Truvada separately to switch to the new pill.
Some on other combinations may choose not to make the switch, however. Some may have strains of the virus in their bodies that have become resistant to one of the drugs in the new pill. Others may not be able to tolerate the side effects. Sustiva, for example, has a reputation for causing unsettling vivid dreams, at least during the first month it is administered.
In addition, the new pill is rather large and some people may find it difficult to swallow.
The once-daily treatment became feasible only a few years ago with the development of individual drugs that needed to be taken only once a day. But no single company controlled all the drugs needed for an effective combination, and it is rare for rivals to collaborate.
Executives at Bristol-Myers came up with the idea of approaching Gilead, which was marketing two once-a-day pills, Viread and Emtriva.
Gilead is the nation’s largest supplier of anti-HIV drugs.
This article appeared in the Dallas Voice print edition, July 14, 2006.