Guidance for design and endpoints of clinical trials in chronic hepatitis B - Report from the 2019 EASL-AASLD HBV Treatment Endpoints Conference
Representatives from academia, industry, regulatory agencies, and patient groups convened in March 2019 with the primary goal of developing agreement on chronic HBV treatment endpoints to guide clinical trials aiming to ‘cure’ HBV. Agreement among the conference participants was reached on some key...
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| Published in | Journal of hepatology Vol. 72; no. 3; pp. 539 - 557 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Netherlands
Elsevier B.V
01.03.2020
Elsevier Science Ltd |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Representatives from academia, industry, regulatory agencies, and patient groups convened in March 2019 with the primary goal of developing agreement on chronic HBV treatment endpoints to guide clinical trials aiming to ‘cure’ HBV. Agreement among the conference participants was reached on some key points. ‘Functional’ but not sterilising cure is achievable and should be defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post-treatment. The primary endpoint of phase III trials should be functional cure; HBsAg loss in ≥30% of patients was suggested as an acceptable rate of response in these trials. Sustained virologic suppression (undetectable serum HBV DNA) without HBsAg loss 6 months after discontinuation of treatment would be an intermediate goal. Demonstrated validity for the prediction of sustained HBsAg loss was considered the most appropriate criterion for the approval of new HBV assays to determine efficacy endpoints. Clinical trials aimed at HBV functional cure should initially focus on patients with HBeAg-positive or negative chronic hepatitis, who are treatment-naïve or virally suppressed on nucleos(t)ide analogues. A hepatitis flare associated with an increase in bilirubin or international normalised ratio should prompt temporary or permanent cessation of an investigational treatment. New treatments must be as safe as existing nucleos(t)ide analogues. The primary endpoint for phase III trials for HDV coinfection should be undetectable serum HDV RNA 6 months after stopping treatment. On treatment HDV RNA suppression associated with normalisation of alanine aminotransferase is considered an intermediate goal. In conclusion, regarding HBV ‘functional cure’, the primary goal is sustained HBsAg loss with undetectable HBV DNA after completion of treatment and the intermediate goal is sustained undetectable HBV DNA without HBsAg loss after stopping treatment. |
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| AbstractList | Representatives from academia, industry, regulatory agencies, and patient groups convened in March 2019 with the primary goal of developing agreement on chronic HBV treatment endpoints to guide clinical trials aiming to ‘cure’ HBV. Agreement among the conference participants was reached on some key points. ‘Functional’ but not sterilising cure is achievable and should be defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post-treatment. The primary endpoint of phase III trials should be functional cure; HBsAg loss in ≥30% of patients was suggested as an acceptable rate of response in these trials. Sustained virologic suppression (undetectable serum HBV DNA) without HBsAg loss 6 months after discontinuation of treatment would be an intermediate goal. Demonstrated validity for the prediction of sustained HBsAg loss was considered the most appropriate criterion for the approval of new HBV assays to determine efficacy endpoints. Clinical trials aimed at HBV functional cure should initially focus on patients with HBeAg-positive or negative chronic hepatitis, who are treatment-naïve or virally suppressed on nucleos(t)ide analogues. A hepatitis flare associated with an increase in bilirubin or international normalised ratio should prompt temporary or permanent cessation of an investigational treatment. New treatments must be as safe as existing nucleos(t)ide analogues. The primary endpoint for phase III trials for HDV coinfection should be undetectable serum HDV RNA 6 months after stopping treatment. On treatment HDV RNA suppression associated with normalisation of alanine aminotransferase is considered an intermediate goal. In conclusion, regarding HBV ‘functional cure’, the primary goal is sustained HBsAg loss with undetectable HBV DNA after completion of treatment and the intermediate goal is sustained undetectable HBV DNA without HBsAg loss after stopping treatment. Representatives from academia, industry, regulatory agencies, and patient groups convened in March 2019 with the primary goal of developing agreement on chronic HBV treatment endpoints to guide clinical trials aiming to 'cure' HBV. Agreement among the conference participants was reached on some key points. 'Functional' but not sterilising cure is achievable and should be defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post-treatment. The primary endpoint of phase III trials should be functional cure; HBsAg loss in ≥30% of patients was suggested as an acceptable rate of response in these trials. Sustained virologic suppression (undetectable serum HBV DNA) without HBsAg loss 6 months after discontinuation of treatment would be an intermediate goal. Demonstrated validity for the prediction of sustained HBsAg loss was considered the most appropriate criterion for the approval of new HBV assays to determine efficacy endpoints. Clinical trials aimed at HBV functional cure should initially focus on patients with HBeAg-positive or negative chronic hepatitis, who are treatment-naïve or virally suppressed on nucleos(t)ide analogues. A hepatitis flare associated with an increase in bilirubin or international normalised ratio should prompt temporary or permanent cessation of an investigational treatment. New treatments must be as safe as existing nucleos(t)ide analogues. The primary endpoint for phase III trials for HDV coinfection should be undetectable serum HDV RNA 6 months after stopping treatment. On treatment HDV RNA suppression associated with normalisation of alanine aminotransferase is considered an intermediate goal. In conclusion, regarding HBV 'functional cure', the primary goal is sustained HBsAg loss with undetectable HBV DNA after completion of treatment and the intermediate goal is sustained undetectable HBV DNA without HBsAg loss after stopping treatment.Representatives from academia, industry, regulatory agencies, and patient groups convened in March 2019 with the primary goal of developing agreement on chronic HBV treatment endpoints to guide clinical trials aiming to 'cure' HBV. Agreement among the conference participants was reached on some key points. 'Functional' but not sterilising cure is achievable and should be defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post-treatment. The primary endpoint of phase III trials should be functional cure; HBsAg loss in ≥30% of patients was suggested as an acceptable rate of response in these trials. Sustained virologic suppression (undetectable serum HBV DNA) without HBsAg loss 6 months after discontinuation of treatment would be an intermediate goal. Demonstrated validity for the prediction of sustained HBsAg loss was considered the most appropriate criterion for the approval of new HBV assays to determine efficacy endpoints. Clinical trials aimed at HBV functional cure should initially focus on patients with HBeAg-positive or negative chronic hepatitis, who are treatment-naïve or virally suppressed on nucleos(t)ide analogues. A hepatitis flare associated with an increase in bilirubin or international normalised ratio should prompt temporary or permanent cessation of an investigational treatment. New treatments must be as safe as existing nucleos(t)ide analogues. The primary endpoint for phase III trials for HDV coinfection should be undetectable serum HDV RNA 6 months after stopping treatment. On treatment HDV RNA suppression associated with normalisation of alanine aminotransferase is considered an intermediate goal. In conclusion, regarding HBV 'functional cure', the primary goal is sustained HBsAg loss with undetectable HBV DNA after completion of treatment and the intermediate goal is sustained undetectable HBV DNA without HBsAg loss after stopping treatment. |
| Author | Lok, Anna Suk-Fong Mishra, Poonam Buti, Maria Schlottmann, Silke Janssen, Harry L.A. Lampertico, Pietro Papatheodoridis, George Dandri, Maura Liang, Jake Feld, Jordan J. Chang, Kyong-Mi Locarnini, Stephen Buchholz, Stephanie Maini, Mala K. Terrault, Norah A. Brunetto, Maurizia R. Wedemeyer, Heiner Zoulim, Fabien Ghany, Marc Petersen, Jörg Kennedy, Patrick Wang, Su Chan, Henry L.Y. Berg, Thomas Dusheiko, Geoffrey Ferrari, Carlo Cornberg, Markus |
| Author_xml | – sequence: 1 givenname: Markus surname: Cornberg fullname: Cornberg, Markus email: Cornberg.Markus@mh-hannover.de organization: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany – sequence: 2 givenname: Anna Suk-Fong surname: Lok fullname: Lok, Anna Suk-Fong organization: Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA – sequence: 3 givenname: Norah A. surname: Terrault fullname: Terrault, Norah A. organization: Division of Gastrointestinal and Liver Diseases, Keck Medicine at University of Southern California, Los Angeles, CA, USA – sequence: 4 givenname: Fabien surname: Zoulim fullname: Zoulim, Fabien organization: Hepatology Department, Hospices Civils de Lyon, INSERM U1052, University of Lyon, France – sequence: 5 givenname: Thomas surname: Berg fullname: Berg, Thomas – sequence: 6 givenname: Maurizia R. surname: Brunetto fullname: Brunetto, Maurizia R. – sequence: 7 givenname: Stephanie surname: Buchholz fullname: Buchholz, Stephanie – sequence: 8 givenname: Maria surname: Buti fullname: Buti, Maria – sequence: 9 givenname: Henry L.Y. surname: Chan fullname: Chan, Henry L.Y. – sequence: 10 givenname: Kyong-Mi surname: Chang fullname: Chang, Kyong-Mi – sequence: 11 givenname: Maura surname: Dandri fullname: Dandri, Maura – sequence: 12 givenname: Geoffrey surname: Dusheiko fullname: Dusheiko, Geoffrey – sequence: 13 givenname: Jordan J. surname: Feld fullname: Feld, Jordan J. – sequence: 14 givenname: Carlo surname: Ferrari fullname: Ferrari, Carlo – sequence: 15 givenname: Marc surname: Ghany fullname: Ghany, Marc – sequence: 16 givenname: Harry L.A. surname: Janssen fullname: Janssen, Harry L.A. – sequence: 17 givenname: Patrick surname: Kennedy fullname: Kennedy, Patrick – sequence: 18 givenname: Pietro surname: Lampertico fullname: Lampertico, Pietro – sequence: 19 givenname: Jake surname: Liang fullname: Liang, Jake – sequence: 20 givenname: Stephen surname: Locarnini fullname: Locarnini, Stephen – sequence: 21 givenname: Mala K. surname: Maini fullname: Maini, Mala K. – sequence: 22 givenname: Poonam surname: Mishra fullname: Mishra, Poonam – sequence: 23 givenname: George surname: Papatheodoridis fullname: Papatheodoridis, George – sequence: 24 givenname: Jörg surname: Petersen fullname: Petersen, Jörg – sequence: 25 givenname: Silke surname: Schlottmann fullname: Schlottmann, Silke – sequence: 26 givenname: Su surname: Wang fullname: Wang, Su – sequence: 27 givenname: Heiner surname: Wedemeyer fullname: Wedemeyer, Heiner |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31730789$$D View this record in MEDLINE/PubMed |
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| Copyright | 2019 European Association for the Study of the Liver, American Association for the Study of Liver Diseases Copyright © 2019 European Association for the Study of the Liver, American Association for the Study of Liver Diseases. Published by Elsevier B.V. All rights reserved. Copyright Elsevier Science Ltd. Mar 2020 |
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| Keywords | CpAM Antiviral therapy Nucleos(t)ide analogues Immunomodulatory therapy Hepatitis B surface antigen Hepatitis D |
| Language | English |
| License | Copyright © 2019 European Association for the Study of the Liver, American Association for the Study of Liver Diseases. Published by Elsevier B.V. All rights reserved. |
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| SubjectTerms | Alanine Alanine transaminase Alanine Transaminase - blood Antiviral Agents - therapeutic use Antiviral therapy Bilirubin Biomarkers - blood Clinical trials Clinical Trials, Phase III as Topic - methods Coinfection - blood Coinfection - drug therapy Coinfection - virology CpAM Deoxyribonucleic acid DNA DNA, Viral - blood Hepatitis Hepatitis B Hepatitis B e antigen Hepatitis B surface antigen Hepatitis B Surface Antigens - blood Hepatitis B virus - genetics Hepatitis B virus - immunology Hepatitis B, Chronic - blood Hepatitis B, Chronic - drug therapy Hepatitis B, Chronic - virology Hepatitis D Hepatitis D, Chronic - blood Hepatitis D, Chronic - drug therapy Hepatitis D, Chronic - virology Hepatitis Delta Virus - genetics Humans Immunomodulatory therapy Nucleos(t)ide analogues Patients Research Design Ribonucleic acid RNA Sustained Virologic Response |
| Title | Guidance for design and endpoints of clinical trials in chronic hepatitis B - Report from the 2019 EASL-AASLD HBV Treatment Endpoints Conference |
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