Direct‐acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: Scientific and regulatory approaches to clinical trial designs

Poonam Mishra, Jeffrey Murray, Debra Birnkrant – 7 May 2015 – Therapeutic options for treatment of chronic hepatitis C have improved substantially since the approval of direct‐acting antiviral agents (DAAs). Several interferon (IFN)‐free or IFN‐ and ribavirin (RBV)‐free treatment regimens with shorter durations and improved efficacy and safety profiles are now available. The U.S.

Direct‐acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: Scientific and regulatory approaches to clinical trial designs

Poonam Mishra, Jeffrey Murray, Debra Birnkrant – 7 May 2015 – Therapeutic options for treatment of chronic hepatitis C have improved substantially since the approval of direct‐acting antiviral agents (DAAs). Several interferon (IFN)‐free or IFN‐ and ribavirin (RBV)‐free treatment regimens with shorter durations and improved efficacy and safety profiles are now available. The U.S.

Direct‐acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: Scientific and regulatory approaches to clinical trial designs

Poonam Mishra, Jeffrey Murray, Debra Birnkrant – 7 May 2015 – Therapeutic options for treatment of chronic hepatitis C have improved substantially since the approval of direct‐acting antiviral agents (DAAs). Several interferon (IFN)‐free or IFN‐ and ribavirin (RBV)‐free treatment regimens with shorter durations and improved efficacy and safety profiles are now available. The U.S.

CD44 and CXCL9 serum protein levels predict the risk of clinically significant allograft rejection after liver transplantation

Nathanael Raschzok, Anja Reutzel‐Selke, Rosa Bianca Schmuck, Mehmet Haluk Morgul, Ulrich Gauger, Kukuh Aji Prabowo, Laura‐Marie Tannus, Annekatrin Leder, Benjamin Struecker, Sabine Boas‐Knoop, Michael Bartels, Sven Jonas, Christian Lojewski, Gero Puhl, Daniel Seehofer, Marcus Bahra, Andreas Pascher, Johann Pratschke, Igor Maximilian Sauer – 6 May 2015 – The diagnosis of acute cellular rejection (ACR) after liver transplantation is based on histological analysis of biopsies because noninvasive biomarkers for allograft rejection are not yet established for clinical routines.

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