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New Combo Pill Submitted to FDA

February 2011

In November 2010, a new combo pill was submitted to the FDA for approval. If approved, this would be the second full-regimen pill on the market next to Atripla. The pill combines the new NNRTI rilpivirine with a standard NRTI combination of Truvada (tenofovir + emtricitabine) and may be approved before the end of 2011 for people new to HIV treatment.

In studies comparing the new combo pill to Atripla [Sustiva (efavirenz) + Truvada], the new combo pill appears to be as potent as Atripla, though with fewer side effects. Many have difficulty tolerating some of the potential side effects from the Sustiva in Atripla, such as vivid or disturbing dreams. Studies showed that nausea was common among both regimens. However, rash and central nervous system side effects were much less likely to occur with the new combo pill.




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