FDA Approves Once-Daily HIV Pill Complera

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Updated: 7/23 6:07 pm

Aug. 11, 2011 -- The FDA has approved Gilead's Complera, the second complete HIV treatment in a single, once-daily pill.

Complera is a combination of Truvada (which combines the nucleoside reverse transcriptase inhibitors Emtriva and Viread) and the non-nucleoside reverse transcriptase inhibitor Edurant.

Truvada has been around since 2004 and is a popular component of so-called "AIDS drug cocktails" or combination HIV therapy. Edurant, also known as rilpivirine, was approved last May.

The first single-tablet regimen for HIV, Gilead's Atripla, was approved by the FDA in 2006. Yet another single-pill treatment from Gilead, the four-drug Quad, is in advanced clinical trials.

Complera is approved as a first-line treatment for adults with HIV infection who have not yet begun treatment with any other HIV medications.

It's not for everyone, as different doctors may prefer to prescribe different HIV drug combinations for different patients. However, the once-daily formulation makes it much easier for people to take their medication exactly as prescribed. That's extremely important for people with HIV, as the AIDS virus can quickly become resistant to HIV drugs when doses are missed.

Like all HIV drugs, Complera can have serious side effects. These include lactic acidosis and severe liver damage -- side effects linked to most drugs in the class of nucleoside reverse transcriptase inhibitors when given as part of combination therapy.

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