HIV and AIDS Activities > Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination

On August 10, 2011, FDA approved Complera, a fixed dose combination (FDC) drug product containing emtricitabine/rilpivirine/tenofovir DF (FTC/RPV/TDF) for the treatment of HIV. The recommended dose of Complera™ is one tablet, containing 200mg/25mg/300mg of FTC/RPV/TDF, once daily, taken orally with a meal.

Emtricitabine/rilpivirine/tenofovir DF FDC is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in antiretroviral treatment naïve adult patients (patients who have never taken HIV therapies, and are starting HIV therapy for the first time).

Emtricitabine/rilpivirine/tenofovir DF FDC is a complete regimen for treatment of HIV infection in treatment naïve patients because it contains a Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI) (rilpivirine) and 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (emtricitabine and tenofovir DF).

The following points should be considered when initiating therapy with emtricitabine/rilpivirine/tenofovir DF FDC:

* More rilpivirine treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared to subjects with HIV-1 RNA less than 100,000 copies/mL at the start of therapy
* The observed virologic failure rate in rilpivirine treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz
* More subjects treated with rilpivirine developed lamivudine/emtricitabine associated resistance compared to efavirenz

For more information, please visit: Complera ►

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