<ul><li>EASL and Liver Research at the European Level </li></ul><ul><li>The viRgil network of excellence </li></ul><ul><li...
General Objectives <ul><li>TO ORGANISE THE EUROPEAN  FIGHT AGAINST VIRAL DRUG RESISTANCE </li></ul><ul><li>WITH A COMPREHE...
HBV resistance to therapy % of patients 5% 13% 24% 0% 0% 0 20 40 60 80 year 1 LAM  1 1 Lai et al. Clin Infect Dis. 2003;36...
HBV resistance to nucleoside analogs Allen Hepatology 1998, Delaney J Virol 2003, Angus Gastroenterology 2003,  Villeneuve...
Chronic hepatitis C Treatment response and failure 0% 10% 20% 30% 40% 50% 60% 70% 6% Standard  IFNa monotherapy (24 weeks)...
HCV : the new targets and the resistance problem Di Bisceglie et al., Hepatology 2002
Specific  Objectives <ul><li>Improve the understanding, diagnosis, surveillance, and treatment of  antiviral drug resistan...
viRgil Network A European Coverage + ISRAEL
60 scientific teams 12 European Member States 55 institutions Steering Committee Project Management  Team <ul><li>Governin...
viRgil Network The structure
Major strengths <ul><li>Complementarity/Excellence of the teams </li></ul><ul><li>Exchange of material, expertise, persone...
Launching of viRgil activities <ul><li>Kick-off meeting, June 27-29, 2004 in Lyon </li></ul><ul><ul><li>Launching at the R...
ViRgil launching  Lyon, June 27-29
<ul><li>Common definition of viral drug resistance </li></ul><ul><li>Common clinical record form to </li></ul><ul><ul><li>...
viRgil definition of  viral drug resistance
 
viRgil ready to start clinical studies ! <ul><li>Ongoing activities of the centralized platforms  </li></ul><ul><li>Implem...
Physician Physician Database Liver Expert Patient Follow up Best practice Consultation request Report D Doc
Dissemination of knowledge activities <ul><li>Endorsement/organization of several meetings </li></ul><ul><ul><li>2004: Imm...
http://www.virgil-net.org/
<ul><li>Interaction between partners </li></ul><ul><ul><li>Exchange of material / methodology </li></ul></ul><ul><ul><li>E...
J Weinbach, PM INSERM-transfert F Zoulim, coordinator INSERM M Manns B Lina J Neyts S Schalm JM Cohen JM Pawlotsky M Zambo...
 
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    1. 1. <ul><li>EASL and Liver Research at the European Level </li></ul><ul><li>The viRgil network of excellence </li></ul><ul><li>VIRGIL: COMBATING RESISTANCE TO ANTIVIRAL TREATMENTS </li></ul><ul><li>April 17, 2005 </li></ul><ul><li>EASL, Paris </li></ul>Fabien Zoulim INSERM Unit 271, Lyon
    2. 2. General Objectives <ul><li>TO ORGANISE THE EUROPEAN FIGHT AGAINST VIRAL DRUG RESISTANCE </li></ul><ul><li>WITH A COMPREHENSIVE AND INTEGRATED ULTRASTRUCTURE </li></ul><ul><li>MODEL: 3 major viral diseases in Europe </li></ul><ul><ul><li>Influenza </li></ul></ul><ul><ul><ul><li>Annual epidemic outbreaks </li></ul></ul></ul><ul><ul><ul><ul><li>114 000 hospitalizations / year </li></ul></ul></ul></ul><ul><ul><ul><ul><li>21 000 Deaths / year </li></ul></ul></ul></ul><ul><ul><ul><li>Anticipation for pandemic planning and viral resistance </li></ul></ul></ul><ul><ul><li>Chronic hepatitis </li></ul></ul><ul><ul><ul><li>Hepatitis B </li></ul></ul></ul><ul><ul><ul><ul><li>15 million chronic carriers in Europe </li></ul></ul></ul></ul><ul><ul><ul><li>Hepatitis C </li></ul></ul></ul><ul><ul><ul><ul><li>8-10 million chronic carriers in Europe </li></ul></ul></ul></ul><ul><ul><ul><li>Responsible for 2/3 of cirrhosis and liver cancer </li></ul></ul></ul><ul><ul><ul><li>Treatment failure :50-60% patients </li></ul></ul></ul>
    3. 3. HBV resistance to therapy % of patients 5% 13% 24% 0% 0% 0 20 40 60 80 year 1 LAM 1 1 Lai et al. Clin Infect Dis. 2003;36:687-96 2 Schiffman ML et al. Hepatology 2004; 40:172A 3 Lai CL, et al. Hepatology 2003; 38: 262A 4 Colonno RJ, et al. Hepatology 2004; 40: 661A 5 Xiong et al. EASL 2005 6 Angus et at Gastroenterology (2003) 7. Villeneuve et al J. Hepatol. 2% 42% year 2 ? ? ? 7% 53% year 3 ? ? ? 70% 15% year 4 ? ? ? FTC 2 LdT 3 ADV 5 4 ETV
    4. 4. HBV resistance to nucleoside analogs Allen Hepatology 1998, Delaney J Virol 2003, Angus Gastroenterology 2003, Villeneuve J Hepatol 2003, Lai AASLD 2003, Colonno HepDart 2003 845 a.a. Terminal protein spacer Pol/RT RNaseH A B C E D 1 183 349 692 YMDD V173L L180M M204I/V GVGLSPFLLA I(G) II(F) (rt1) (rt 344) LAM 1 / FTC 2 ETV * 4 T184A/G/I/S S202G/I M250V ADV 3 A181V N236T LdT 5 M204I Terminal protein spacer
    5. 5. Chronic hepatitis C Treatment response and failure 0% 10% 20% 30% 40% 50% 60% 70% 6% Standard IFNa monotherapy (24 weeks) 16-30% Standard IFN-a monotherapy (48weeks) 41-45% IFN-a2b + Ribavirin Peg-IFN-a2b/2a + Ribavirin 54-56% Manns, Lancet 2001; Fried NEJM 2002
    6. 6. HCV : the new targets and the resistance problem Di Bisceglie et al., Hepatology 2002
    7. 7. Specific Objectives <ul><li>Improve the understanding, diagnosis, surveillance, and treatment of antiviral drug resistance </li></ul><ul><li>Improved benefit/cost of viral disease management </li></ul><ul><li>Integration of European research excellence and capacities </li></ul>
    8. 8. viRgil Network A European Coverage + ISRAEL
    9. 9. 60 scientific teams 12 European Member States 55 institutions Steering Committee Project Management Team <ul><li>Governing Board </li></ul><ul><ul><li>Scientific Advisory Board </li></ul></ul><ul><ul><li>Patients Advocay Groups </li></ul></ul><ul><li>7 Pharmaceutical </li></ul><ul><li>companies </li></ul><ul><li>/ Biotech </li></ul><ul><ul><li>Bioalliance </li></ul></ul><ul><ul><li>BioMérieux </li></ul></ul><ul><ul><li>LiverDoc </li></ul></ul><ul><ul><li>Retroscreen </li></ul></ul><ul><ul><li>Riotech </li></ul></ul><ul><ul><li>Tripep </li></ul></ul>viRgil Network composition EC grant for integration: 9 M € / 4 years
    10. 10. viRgil Network The structure
    11. 11. Major strengths <ul><li>Complementarity/Excellence of the teams </li></ul><ul><li>Exchange of material, expertise, personel </li></ul><ul><li>Centralized platforms for collaborative clinical and pre-clinical studies </li></ul><ul><ul><li>New drugs </li></ul></ul><ul><ul><li>New assays </li></ul></ul><ul><li>> Integration of activities </li></ul><ul><li>> More ambitious and larger scale projects </li></ul><ul><li>> Additional grants </li></ul>
    12. 12. Launching of viRgil activities <ul><li>Kick-off meeting, June 27-29, 2004 in Lyon </li></ul><ul><ul><li>Launching at the Rhône-Alpes region council headquarters </li></ul></ul><ul><ul><li>Press conference </li></ul></ul><ul><ul><li>Internal meeting with the network members </li></ul></ul><ul><li>Management structure in place </li></ul><ul><li>Website in place: http://www.virgil-net.org/ </li></ul><ul><ul><li>Intranet </li></ul></ul><ul><ul><li>Extranet </li></ul></ul><ul><ul><li>Links with scientific societies (EASL, national liver societies, etc…) </li></ul></ul>
    13. 13. ViRgil launching Lyon, June 27-29
    14. 14. <ul><li>Common definition of viral drug resistance </li></ul><ul><li>Common clinical record form to </li></ul><ul><ul><li>Collect clinical data </li></ul></ul><ul><ul><li>Collect samples for further biological studies </li></ul></ul><ul><ul><li>Identify patients for clinical studies </li></ul></ul>The basis for clinical research
    15. 15. viRgil definition of viral drug resistance
    16. 17. viRgil ready to start clinical studies ! <ul><li>Ongoing activities of the centralized platforms </li></ul><ul><li>Implementation of a clinical trial platform for European trials </li></ul><ul><li>-> European clinical research infrastructure network (ECRIN) </li></ul><ul><li>Endorsement of viRgil activities by the EASL </li></ul>
    17. 18. Physician Physician Database Liver Expert Patient Follow up Best practice Consultation request Report D Doc
    18. 19. Dissemination of knowledge activities <ul><li>Endorsement/organization of several meetings </li></ul><ul><ul><li>2004: Immunology, HBV, & HCV (Heidelberg) meetings </li></ul></ul><ul><ul><li>2005: HBV meeting (Heidelberg) </li></ul></ul><ul><ul><li>2005: « virology of hepatitis B » book </li></ul></ul><ul><ul><li>2005: Virgil antiviral drug resistance symposium (Lyon), BioVision </li></ul></ul>
    19. 20. http://www.virgil-net.org/
    20. 21. <ul><li>Interaction between partners </li></ul><ul><ul><li>Exchange of material / methodology </li></ul></ul><ul><ul><li>Exchange of scientific personel </li></ul></ul><ul><ul><li>Start of new collaborative studies </li></ul></ul><ul><li>Interaction with other European actions </li></ul><ul><ul><li>Biosapiens network </li></ul></ul><ul><ul><li>ECRIN </li></ul></ul><ul><li>Already > 20 viRgil publications and patent applications </li></ul><ul><li>-> Infrastructure for clinical research on drug resistance </li></ul>Dissemination of knowledge
    21. 22. J Weinbach, PM INSERM-transfert F Zoulim, coordinator INSERM M Manns B Lina J Neyts S Schalm JM Cohen JM Pawlotsky M Zambon W Spaan J Oxford G Pape S Ludwig R Bartenschlager A Hay 60 teams & 55 institutions
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