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Working group on improving the utility of patient-reported outcomes collected in HCV clinical care and research

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Interested members of the HCV DrAG are invited to join a working group on improving the utility of patient-reported outcomes (PRO) collected in HCV clinical care and research. PRO instruments, if properly developed and implemented, can provide useful information about the impact of HCV and its treatment on symptoms, functioning, quality of life and treatment satisfaction in clinical care or as study endpoints. PRO provide a systematic and scientifically rigorous method for ensuring patient-centered research by assessing outcomes important to patients. PRO data can help patients understand what to expect with treatment in terms of symptoms, impact on functioning and overall quality of life that can enhance shared decision-making and patient educational information.

We would like to convene the first face-to face working group meeting at AASLD in Boston, MA. If you would like to participate in this working group, please provide the following information to help us organize the working group.
 

Facilitating Drug Development for the Treatment of Liver Disease

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Non-alcoholic fatty liver disease (NAFLD), chronic hepatitis B (HBV), and chronic hepatitis C infection are the leading causes of chronic liver disease and hepatocellular carcinoma in the US. NAFLD, comprising non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH) affects 30% of the adult population and at least 10% of children. NASH related liver transplantations are predicted to eclipse other indications over the next decade, and NASH has emerged as the dominant cause of hepatocellular carcinoma (HCC), the only cancer with rising incidence and third leading cause of cancer mortality.

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Hepatitis C Drug Development Advisory Group (HCV DrAG): An Overview

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The HCV Drug Development Advisory Group (DrAG) is a unique forum that brings together representatives from the U.S. and European regulatory agencies, academia, patient advocates and the pharmaceutical industry to build consensus around drug development-related issues. This Q&A video series features the reflections of several DrAG members on the impact the group has had on HCV drug development.

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In Memory of Dr. Koop

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In Memory of Dr. Koop

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HCV Drug Access for People with Bleeding Disorders

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OCT-17-11   The October 17, 2011 meeting entitled "HCV Drug Access for People with Bleeding Disorders" was the first in a series of meetings that will try and address issues associated with providing access to, if indicated, combination interferon-free experimental direct acting antivirals (DAAs).

The meeting was sponsored by the Forum, and was attended by representatives from regulatory agencies, academia, hemophilia treatment centers, non-profits associated with database management for those affected with bleeding and blood clotting disorders, community medical practitioners, patient advocates and pharmaceutical companies.

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HCV Trials in the Post-Approval Era of Telaprevir and Boceprevir - The Way Forward

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OCT-18-11 The October 18, 2011 meeting sponsored by the Forum was designed to facilitate consensus on issues with the choice of control arm in HCV trials and was attended by representatives from regulatory agencies (US, EMA, Health Canada), NIH, academia, pharmaceutical companies, and patient advocates. 

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Advancing HCV Drug Development: A Collaborative Approach

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DEC-06-10 A public meeting on HCV drug development was held Monday, December 6, 2010, in Washington, DC.

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HEP DART 2009, Frontiers in Drug Development for Viral Hepatitis Education Round-Table

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DEC-9-09 An education roundtable was held at the  HEP DART meeting in Hawaii On Tuesday, December 8, 2009  to educate Hepatitis C virus infected patients and update physicians who treat them about risk for, and avoidance of drug resistance to the next generation of HCV antiviral therapies.
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