This episode follows S2 E43 in discussing the possible role of NASH cirrhosis clinical trials in the transition from biopsy as gold standard to a post-biopsy world. Stephen Harrison starts this conversation by discussing why we focus on NASH cirrhosis and goes on to review the recent presentation of results from the REVERSE study on obeticholic acid. Jörn Schattenberg and Mazen Noureddin add their perspectives to the conversation.
In this conversation, Stephen starts by pointing out that non-cirrhotic NASH trials and NASH cirrhosis trials differ significantly in goals, endpoints and patient severity. From there, he dives into the NASH cirrhosis trial group with his review of REVERSE, which Vlad Ratziu presented at AASLD. Jörn Schattenberg and Mazen Noureddin also comment on design of this trial. Conversation focuses on two issues: who is the optimal patient for a NASH cirrhosis trial and what is the most appropriate attainable endpoint and, therefore, clinical design? On the optimal patient issue, the group agrees the ideal patient is a well-compensated cirrhotic, because the presence of portal hypertension makes the entire healing issue so much more complex. There was less agreement on the optimal design question.