Experimental HCV drugs for HIV/HCV coinfected people: workshop on trial design

On 20 November 2009, the European AIDS Treatment Groups (EATG) organised the Brussels I / Sitges III third international workshop: “Clinical Trials Design: Experimental HCV Drugs for HIV/HCV Co-infected People” in Brussels, Belgium.

The 2009 meeting built on the success of two previous meetings held in Sitges in 2007 and 2008, that were instrumental in advancing HCV drug development in co-infected people. The European Medicines Agency (EMA) has now issued guidelines and recommendations, for HCV drug development including pre-approval studies in HIV co-infected people. Although FDA has not formally issued recommendations, they also support pre-approval studies in HIV/HCV coinfected people. Community members contributed to these guidelines.

Some companies also initiated clinical trials in co-infected people, while others began consulting with the community to discuss their HCV early drug development programs for HIV/HCV co-infected people.

The objectives of the 2009 meeting were to promote a multi-stakeholder discussion on how to move HCV research and clinical trial design forward for HIV/HCV coinfected people.

The meeting was attended by approximately 50 participants representing European and US Community Advocates, regulatory agencies (FDA and EMA), pharmaceutical companies, clinicians and researchers.

Presentations from the meeting are available to download form the EATG website: -20-Brussels

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