November 8, 2013

AASLD 2013: Hepatitis Debrief by Mark Sulkowski MD

Provided by NATAP

Reported by Jules Levin

from Jules: In this very well done AASLD Hepatitis Debrief presented at the very end of the conference by Dr Mark Sulkowski he takes us through the key presentations & messages presented at this AASLD. The conference was breathtaking because of the new data from studies of new oral HCV treatments (DAAs, direct acting antivirals). This update covers new data reviews for Simeprevir & Faldaprevir in combination with Peg/Rbv, Sofosbuvir in combination with Peg/Rbv, and coinfection data including Sofosbuvir+Rbv for 24 weeks in GT 1 coinfected. As well key GT3 data are reported from the VALENCE Study with Sofosbuvir+Peg/Rbv. The SYNERGY Study from the NIH in African-Americans provided data supporting that DAA oral therapies will be equally effective for African-Americans (see the report, link below). The COSMOS Study, cohorts 1 & 2 report results of the IFN-free regimen of Simeprevir+Sofosbuvir in null responders & advanced disease with 96-100% SVR rates. Previously reported Daclatasvir+Sofosbuvir IFN-free results showed 100% SVR in HCV treatment-naives & for those previously treated & who failed telaprevir & boceprevir. Several select epidemiological studies are covered here including confirming the risk for HCC even after SVR highlighting the compelling key to avoid undue delay of HCV therapy, and the Global Burden of HCC. The FDA is expected to announce by the end of November & the beginning of December that Simeprevir+Peg/Rbv will be approved, that Sofosbuvir+Peg/Rbv & Sofosbuvir+RBv will be approved. In 2014 both Abbvie & Gilead will be submitting applications to the FDA for approvals for their IFN-free oral regimens to treat HCV for 12 weeks. In development, earlier developmental stages are BMS, Merck, & Boehringer Ingelheim with similarly promising IFN-free all oral IFN-free regimens, with all these 3 companies's regimens presented at this conference, phase 2 data, and mentioned below.

Here is a link to the NATAP conference coverage which had already reported these data during the conference in real-time:
64rd Annual Meeting of the American Association for the Study of Liver Diseases Washington, DC Nov 1-5 2013

Presented at AASLD 2013 Nov 1-4 Wash DC by

Mark Sulkowski, MD
Professor of Medicine
Division of Infectious Diseases and Gastroenterology/Hepatology
Johns Hopkins University School of Medicine
Baltimore, MD.





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