Brussels I - Sitges III (Nov 20, Brussels)

3rd International Workshop “Clinical Trials Design: Experimental HCV Drugs for HIV/HCV Co-infected People”

On November 20th, 2009, EATG organized 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 Brussels I / Sitges III meeting built on the success of two previous meetings focusing on access to HCV experimental drugs for HIV/HCV coinfected people, and development of a research agenda to facilitate the process. Sitges I and II, held in 2007 and 2008, were instrumental in advancing HCV drug development in co-infected people. EMEA 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.

Download here the Sitges I and II declarations and meeting reports:

Sitges I Declaration.pdf (321.78 kB)

Sitges II Declaration.pdf (273.97 kB)

Sitges I report.PDF (399.47 kB)

Sitges II report.PDF (1.85 MB)

The Brussels I / Sitges III meeting continued this momentum. The objectives 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:

European and US Community Advocates from EATG, TAG, NATAP, Project Inform, HACA, ELPA, and the World Hepatitis Alliance
Regulatory agencies (FDA and EMEA)
Pharmaceutical companies (Abbott, Boehringer-Ingelheim, BMS, Gilead, MSD, Roche, Schering-Plough, Tibotec)
Clinicians and Researchers, who are specialists in HIV and HCV treatment and clinical research

Download here the meeting agenda:

Agenda Brussels I Sitges III meeting.doc (86.50 kB)

The morning session was centred around the following presentations:

Dr Filip Josephson from EMEA presented the EMEA/CHMP guidelines on the clinical evaluation of DAA intended for treatment of chronic hepatitis C.
Filip Josephson.pdf (847.50 kB)
Dr Kimberly Struble from FDA presented the FDA perspectives on clinical trial design for new HCV products.
Kimberly Struble.pdf (69.83 kB)
Dr Stéphane Chevaliez from the Department of Virology of the Hôpital Henri Mondor in France provided an update on the resistance to HCV Drugs & its clinical Implications.
Stephane Chevaliez.pdf (3.56 MB)

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Then, the afternoon session featured a dynamic roundtable of experts to discuss design of clinical trials for experimental HCV drugs in HIV/HCV coinfected people.

Roundtable participants:

Dr. Bernard Hirschel (Division des Maladies infectieuses, Unité VIH/SIDA Hôpital Universitaire de Genève)
Dr. Juergen Rockstroh (Department of Internal Medicine I, Bonn University, Bonn, Germany)
Dr. Massimo Puoti (Department of Infectious Diseases, University of Brescia, Italy)
Dr. Josep Mallolas (Infectious Diseases Service, Hospital Clínic, Barcelona, Spain)

Following the roundtable, each pharmaceutical company attending the meeting was given the opportunity to comment on the discussions that had arisen during the day, and describe their plans for including HIV/HCV coinfected populations in their clinical trials for new hepatitis C drugs.

Finally the meeting ended with a very moving speech from Joan Tallada, EATG, calling for a strong multi-stakeholder response to accelerate development of safe and effective HCV drugs for HIV/HCV coinfected population.

A full Brussels I / Sitges III meeting report is in preparation and should be available shortly.