The European Commission has granted marketing authorisation for Eviplera® (emtricitabine/rilpivirine/tenofovir disoproxil), a once-daily, single-tablet regimen for the treatment of HIV-1 infection in antiretroviral treatment-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/ml.
The authorisation allows for the commercialisation of Eviplera in all 27 countries of the European Union.
“As people with HIV are living and remaining on treatment longer, the availability of new simplified therapeutic options has become even more critical,” said Dr. Mark Nelson, Service Director for the HIV Directorate, Chelsea and Westminster Hospital, London, United Kingdom.
“Eviplera has the potential to be an important new treatment option for patients starting HIV therapy because it streamlines an effective HIV treatment regimen into a single daily tablet.”
Eviplera combines Gilead’s Truvada®, a fixed-dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine 200mg and tenofovir disoproxil 245mg, and Tibotec Pharmaceuticals’ rilpivirine 25mg, marketed by Janssen-Cilag International N.V. as Edurant®.
Eviplera is the second single-tablet HIV regimen to be authorised in the EU.
The first, Atripla® (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil 245mg), became available in 2007 and is also marketed by Gilead, in partnership with Bristol-Myers Squibb and Merck & Co.
The authorisation of Eviplera was supported by 48-week data from two Phase 3 double-blind, active controlled, randomized studies (ECHO and THRIVE) conducted by Tibotec that evaluated the safety and efficacy of rilpivirine compared to efavirenz in treatment-naïve HIV-infected adults. Both studies included a background regimen of two nucleosides/nucleotides, which for the majority of patients was Truvada.
A bioequivalence study demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate administered separately.
The single-tablet regimen received regulatory authorisation from the U.S. Food and Drug Administration under the trade name Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) in August 2011.