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Dec 09, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate regulatory update

Germany's Federal Joint Committee (G-BA) said in a final benefit assessment that HIV drug Stribild from Gilead has "no additional benefit" over Atripla emtricitabine/tenofovir/efavirenz, a comparator requested by G-BA, in therapy-naïve patients. In a September preliminary assessment, Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) had said Stribild was worse than Atripla because it was associated with more AIDS-defining events and serious side effects. G-BA said the overall incidence of AIDS-defining events in the Stribild group was low and that Stribild led to significant improvements in immune deficiency (see BioCentury, Sept. 23). G-BA...

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