Benjamin Maasoumy1, Peter Buggisch2, Stefan Mauss3, Klaus H W Boeker4, Tobias Müller5, Rainer Günther6, Tim Zimmermann7, Michael P Manns1, Christoph Sarrazin8,9, Dietrich Hüppe10, Heiner Wedemeyer1,11,12, Johannes Vermehren8. 1. Hannover Medical School, Hannover, Germany. 2. IFI-Institute for Interdisciplinary Medicine, Hamburg, Germany. 3. Center for HIV and Hepatogastroenterology, Duesseldorf, Germany. 4. Leberpraxis Hannover, Hannover, Germany. 5. Charité Campus Virchow-Klinikum (CVK), Berlin, Germany. 6. Universitätsklinikum Schleswig-Holstein, Kiel, Germany. 7. University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany. 8. St. Josef-Hospital, Wiesbaden, Germany. 9. University Hospital Frankfurt, Frankfurt am Main, Germany. 10. Hepatologische Schwerpunktpraxis Herne, Herne, Germany. 11. Leberstiftungs-GmbH Deutschland, Hannover, Germany. 12. Department of Gastroenterology and Hepatology, University Hospital Essen, University of Duisburg Essen, Essen, Germany.
Abstract
BACKGROUND & AIMS: AASLD/IDSA treatment guidelines for hepatitis C virus (HCV) infection state that testing for quantitative HCV RNA can be considered at the end of antiviral treatment (EOT) with interferon-free regimens. However, it remains unclear how to respond to a detectable or even quantifiable HCV RNA result. The aim of this study was to analyse the frequency and predictive value of detectable and quantifiable HCV RNA results at the EOT in patients with HCV genotype 1 infection treated with ledipasvir (LDV) and sofosbuvir (SOF) ± ribavirin (RBV) in a large real-world cohort. METHODS: A retrospective analysis of the DHC-R (Deutsches Hepatitis C-Register, German Hepatitis C-Registry) cohort was performed including all patients who were treated with LDV/SOF ± RBV and in whom HCV RNA testing was done with either the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or the Abbott RealTime HCV assay (ART). RESULTS: The frequency of detectable HCV RNA at the EOT was 7% in this real-world study involving 471 patients. Furthermore, 3% of the patients (n = 14/471) even had quantifiable viral load at the EOT. Detectable and quantifiable results were more frequent if the ART was used for testing. However, SVR was achieved by 32/33 patients (97%) with detectable and even by all 14 patients (100%) with quantifiable HCV RNA results at the EOT. CONCLUSION: Detectable and even quantifiable HCV RNA results are quite frequent if highly sensitive HCV RNA assays are used. However, treatment prolongation is not indicated, as SVR rates remain high in these patients.
BACKGROUND & AIMS: AASLD/IDSA treatment guidelines for hepatitis C virus (HCV) infection state that testing for quantitative HCV RNA can be considered at the end of antiviral treatment (EOT) with interferon-free regimens. However, it remains unclear how to respond to a detectable or even quantifiable HCV RNA result. The aim of this study was to analyse the frequency and predictive value of detectable and quantifiable HCV RNA results at the EOT in patients with HCV genotype 1 infection treated with ledipasvir (LDV) and sofosbuvir (SOF) ± ribavirin (RBV) in a large real-world cohort. METHODS: A retrospective analysis of the DHC-R (Deutsches Hepatitis C-Register, German Hepatitis C-Registry) cohort was performed including all patients who were treated with LDV/SOF ± RBV and in whom HCV RNA testing was done with either the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or the Abbott RealTime HCV assay (ART). RESULTS: The frequency of detectable HCV RNA at the EOT was 7% in this real-world study involving 471 patients. Furthermore, 3% of the patients (n = 14/471) even had quantifiable viral load at the EOT. Detectable and quantifiable results were more frequent if the ART was used for testing. However, SVR was achieved by 32/33 patients (97%) with detectable and even by all 14 patients (100%) with quantifiable HCV RNA results at the EOT. CONCLUSION: Detectable and even quantifiable HCV RNA results are quite frequent if highly sensitive HCV RNA assays are used. However, treatment prolongation is not indicated, as SVR rates remain high in these patients.
Authors: Marcus M Mücke; Benjamin Maasoumy; Julia Dietz; Victoria T Mücke; Christian O Simon; Jesse A Canchola; Marcus Cornberg; Ed G Marins; Michael P Manns; Stefan Zeuzem; Heiner Wedemeyer; Christoph Sarrazin; Johannes Vermehren Journal: PLoS One Date: 2019-11-18 Impact factor: 3.240
Authors: Jake R Morgan; Elizabeth Marsh; Alexandra Savinkina; Sonjelle Shilton; Shaun Shadaker; Tengiz Tsertsvadze; George Kamkamidze; Maia Alkhazashvili; Timothy Morgan; Pam Belperio; Lisa Backus; Waheed Doss; Gamal Esmat; Mohamed Hassany; Aisha Elsharkawy; Wafaa Elakel; Mai Mehrez; Graham R Foster; Constance Wose Kinge; Kara W Chew; Charles S Chasela; Ian M Sanne; Yin M Thanung; Anne Loarec; Khawar Aslam; Suna Balkan; Philippa J Easterbrook; Benjamin P Linas Journal: J Viral Hepat Date: 2022-03-30 Impact factor: 3.517
Authors: Barnaby Flower; Leanne McCabe; Chau Le Ngoc; Hung Le Manh; Phuong Le Thanh; Thuan Dang Trong; Thu Vo Thi; Hang Vu Thi Kim; Thanh Nguyen Tat; Dao Phan Thi Hong; An Nguyen Thi Chau; Tan Dinh Thi; Nga Tran Thi Tuyet; Joel Tarning; Cherry Kingsley; Evelyne Kestelyn; Sarah L Pett; Guy Thwaites; Vinh Chau Nguyen Van; David Smith; Eleanor Barnes; M Azim Ansari; Hugo Turner; Motiur Rahman; Ann Sarah Walker; Jeremy Day; Graham S Cooke Journal: Open Forum Infect Dis Date: 2021-06-09 Impact factor: 3.835