BioCentury
ARTICLE | Clinical News

Eviplera emtricitabine/tenofovir/rilpivirine regulatory update

November 4, 2013 8:00 AM UTC

EMA's CHMP recommended amending the label of Eviplera emtricitabine/tenofovir/rilpivirine to treat HIV-1 infection to exclude its use in patients with known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine. The product is indicated for use in antiretroviral treatment-naïve adult patients with a viral load of <=100,000 copies/mL. Eviplera is a fixed-dose combination of NRTIs emtricitabine and tenofovir and the NNRTI rilpivirine. ...