Medication Monitor



Generic Name (Trade Name—Company)
Notes
August 13, 2011

Emtricitabine/rilpivirine/ tenofovir

(Complera—Gilead)
Once-daily, single-tablet regimen for HIV-1

Uses:

Management of HIV-1 infection in treatment-naive patients

Gilead announced the FDA approval of its single-tablet, once-daily regimen for treatment of HIV-1 infection in treatment-naive adults. Complera contains emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir 300 mg and is taken once daily with a meal.

Approval was based on data from two previously conducted Phase III randomized studies, ECHO and THRIVE, of rilpivirine, on which approval of that drug was based. No new studies were conducted for approval of this new triple combination therapy. A bioequivalence study demonstrated that the triple-drug tablet achieved the same blood levels as each of the drugs administered individually.