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Hepatitis C: Update Bulletin [November 2016]

Product Code:
Publication Date:
November 2016

Gain new KOL insights on the latest events happening in Hepatitis C (HCV). Gilead plans for regulatory submissions after positive data from Phase III trials (POLARIS 1-4) of its fixed-dose combination of sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) in treatment-naïve and treatment-experienced genotype 1 to 6 (GT 1-6) chronic HCV-infected patients. Breakthrough therapy designation granted from the US FDA for AbbVie/Enanta’s glecaprevir and pibrentasvir (G/P) combination in GT1 patients who have failed previous therapy with direct-acting antivirals, based on the Phase II MAGELLAN-1 study. Achillion and Janssen plans to move AL-335 and simeprevir onto Phase IIb trials after favourable Phase IIa trial data reported.

Highlights from this event update bulletin

  • How do KOLs react to the data from POLARIS 1-4 studies for SOF/VEL/VOX?
  • Which patient groups will benefit most from SOF/VEL/VOX?
  • What should Gilead’s sales strategy be for its HCV therapies, especially in GT1?
  • Does AbbVie/Enanta’s G/P have potential as a pan-genotypic therapy option in HCV?
  • Based on data from the completed MAGELLAN-1 trial, how will G/P fare against current players, particularly Harvoni, in GT1? 
  • How does SOF/VEL/VOX compare to G/P? Which treatment is viewed as having the competitive edge and why? 
  • Despite favourable Phase II results, what strategy will Achillion and Janssen have to adopt to best position late entrant odalasvir, AL-335, and simeprevir?
  • Will efforts to reduce the treatment duration of HCV therapies bear fruit?
  • Given that the market is already well served by well tolerated treatment options with high cure rates, what will new HCV therapies need to do to ensure success?



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