IQWiG rebuffs Gilead's HIV drug Eviplera

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 Sciences Inc. (NASDAQ:GILD) 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 one to two 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.

Comments are due April 22, with a final assessment from Germany's Federal Joint Committee (G-BA) expected in mid-June. In 2012, G-BA said Eviplera plus base therapy provides a "marginal" degree of additional benefit in treatment-naïve HIV patients. ...