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Human medicines European public assessment report (EPAR): Eviplera, emtricitabine,rilpivirine,tenofovir disoproxil, Date of authorisation: 27/11/2011, Revision: 26, Status: Authorised

Eviplera has been studied in two main studies in patients with HIV-1 who had not received HIV treatment before. In the first main study involving 690 patients, Eviplera was compared with a similar combination that had efavirenz in place of rilpivirine. The second main study involving 678 patients compared rilpivirine with efavirenz, both being taken with emtricitabine and tenofovir disoproxil or two other nucleotide reverse transcriptase inhibitors.

The main measure of effectiveness was based on the reduction in viral load. Patients who attained a viral load of less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.

Eviplera has also been evaluated in 532 patients who were switched from their current HIV treatment to Eviplera. Patient’s previous treatment consisted either of two nucleotide reverse transcriptase inhibitors and another HIV medicine called a boosted protease inhibitor, or the medicine Atripla. The main measure of effectiveness was based on the maintained reduction in viral load.

The company also presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets given concurrently under similar conditions.

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