Emtricitabin / Rilpivirin / Tenofovirdisoproxil (2) – Eviplera®

• Clinical trials
  • In this multinational, randomised, open-label registration trial, the combination of emtricitabine andrilpivirine/tenofovir disoproxil as a single-tablet regimen following switch from an antiretroviral therapy regimen (consisting of 1 ritonavir-boosted protease inhibitor [PI/r] and 2 nucleoside reverse transcriptase inhibitors [NRTIs]) with continuing this existing therapy (stay on baseline regimen [SBR]).

a) Patients previously treated with antiretroviral therapy (ART)

• The additional benefit of the emtricitabine/rilpivirine/tenofovir disoproxil is not proven in relation to the appropriate comparator therapy for antiretrovirally pre-treated patients with a viral load ≤ 100,000 HIV-1 RNA copies/ml.
• The appropriate comparator therapy was not adequately implemented in the GS-US-264-0106 study.
• Patients in the control group continued the treatment they had been taking prior to the start of the study. This therapy consisted of a combination of a PI/r and two NRTIs. Patients were not given the option to adjust or change their treatment regimen during the randomised controlled trial phase, even though the majority of patients had wished to change their treatment prior to the start of the study.
• The continuation of the previous antiretroviral therapy, consisting of two NRTIs in combination with a PI/r, does not constitute an adequate implementation of the appropriate comparator therapy of ‘individualised antiretroviral therapy’ as defined by the G-BA, as the patients’ previously stated wish to switch treatment was not taken into account in the GS-US-264-0106 study.
• In the trial, a switch option could have been determined prior to randomisation, taking into account the individual circumstances of each patient, which would then have been applied in the control arm following randomisation.
• Furthermore, some of the patients in the GS-US-264-0106 study were treated off-label, as they were affected by resistance-associated mutations against NNRTIs and did not have a marketing authorisation for these medications.
• Conclusion
  • Due to the failure to take the appropriate comparator therapy into account and, furthermore, the insufficient duration, the studies presented are not suitable for the assessment of additional benefit in accordance with Section 35a of the German Social Code, Book V (SGB V).

Courtesy translation only, please refer to the German original.