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U.S. Food and Drug Administration Approves Gilead's Once-Daily HIV Pill Complera

August 11, 2011

The Food and Drug Administration (FDA) on Wednesday approved the once-daily pill Complera for patients not previously treated for HIV.

Complera, made by Gilead Sciences Inc., combines tenofovir/emtricitabine (Truvada) with rilpivirine (Edurant), a Johnson & Johnson drug that received FDA approval in May. The combination treatment will cost approximately $1,705 a month.

A statement by Gilead said the approval of Complera was supported by data from two 48-week, Phase III studies -- ECHO and THRIVE -- that compared rilpivirine to efavirenz (Sustiva), made by Bristol-Myers Squibb Co., in treatment-naive adults with HIV-1 infection. Most patients in the rilpivirine study arm received Truvada as well.

Gilead stressed consideration of the following before starting patients on Complera:

Further, Complera has boxed warnings concerning lactic acidosis/severe hepatomegaly with steatosis and post-treatment acute exacerbation of hepatitis B.

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Excerpted from:
Reuters Health Medical News

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