IQWiG: Olysio offers 'major' benefit vs. Incivek

Germany's Institute for Quality and Efficiency in Healthcare said HCV drug Olysio simeprevir from Medivir AB (SSE:MVIR B) and Johnson & Johnson (NYSE:JNJ) offers "major" additional benefit over Incivek telaprevir in patients with HCV genotype 1 infection who were non-responsive to previous treatment. IQWiG said the ATTAIN trial comparing combinations of either Olysio or Incivek from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) plus peginterferon alfa and ribavirin showed that the HCV NS3/4A protease inhibitor produced fewer serious side effects and premature treatment discontinuations than Incivek. The Olysio group also had fewer skin and gastrointestinal disorders.

IQWiG also said the PILLAR, QUEST-1, QUEST-2 and PROMISE trials suggest that Olysio may increase the likelihood of sustained virologic response (SVR) in treatment-naïve and relapsed patients. However, the agency said the data were "not quantifiable." A final assessment by the Federal Joint Committee (G-BA) on the extent of added benefit is expected in mid-November. Comments are due by Sept. 22. ...