Eviplera emtricitabine/tenofovir/rilpivirine regulatory update

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said in a preliminary benefit assessment that HIV drug Eviplera emtricitabine/tenofovir/rilpivirine from Gilead has "no additional benefit" vs. individualized antiretroviral therapy in previously treated HIV patients - an indication the European Commission approved in November. IQWiG said the 24-week study submitted by Gilead was too short and a trial of 1-2 years would have been necessary. The institute also said the comparator was "not properly implemented" because patients in the study continued to receive prior therapy instead of switching despite side effects with the prior therapy. ...