Johannes Vermehren1, Alessio Aghemo2, Karolin Falconer3, Simone Susser1, Giovanna Lunghi4, Stefan Zeuzem1, Massimo Colombo2, Ola Weiland3, Christoph Sarrazin5. 1. Medizinische Klinik 1, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany. 2. 1st Division of Gastroenterology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy. 3. Division of Infectious Diseases, Department of Medicine, Karolinska University Hospital Huddinge, Stockholm, Sweden. 4. Laboratory of Clinical Chemistry and Microbiology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy. 5. Medizinische Klinik 1, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany. Electronic address: sarrazin@em.uni-frankfurt.de.
Abstract
BACKGROUND & AIMS: The duration of current standard dual and protease inhibitor-based triple therapies for chronic hepatitis C is determined by assessment of early viral kinetics. Little is known about differences between HCV RNA assays for the use in response guided therapy. METHODS: HCV RNA was assessed by two widely used real-time PCR-based assays, Cobas Ampliprep/Cobas TaqMan (CAP), and Real-Time HCV (ART) in 903 samples of hepatitis C genotype 1 patients treated with dual (n=169) or telaprevir-based triple therapy (n=164) in three European countries. RESULTS: Overall, CAP and ART were in excellent agreement for the determination of HCV-RNA concentrations (mean difference 0.21 log10 IU/ml). For treatment-naïve patients treated with peginterferon-alfa and ribavirin a lower rate of undetectable HCV-RNA at week 4 (RVR) was observed for ART (9%) vs. CAP (16%). Although 11/27 (41%) of patients with shortened treatment (24weeks) had detectable HCV-RNA <12IU/ml by ART at week 4 none of these patients experienced virologic relapse after treatment cessation. In patients who received triple therapy, 67% and 37% had undetectable HCV-RNA at week 4 by CAP and ART, respectively. However, 18/31 (58%) eligible patients for shortened treatment based on CAP had detectable HCV-RNA by ART at week 4. Again, relapse was not observed in these patients. CONCLUSIONS: Lower rates of undetectable HCV-RNA at week 4 were observed with ART compared to CAP in patients treated with dual and triple therapies. For ART, detectable <12IU/ml HCV-RNA levels at week 4 may be sufficient as part of the criteria used for selecting patients who receive a shortened treatment regimen.
BACKGROUND & AIMS: The duration of current standard dual and protease inhibitor-based triple therapies for chronic hepatitis C is determined by assessment of early viral kinetics. Little is known about differences between HCV RNA assays for the use in response guided therapy. METHODS: HCV RNA was assessed by two widely used real-time PCR-based assays, Cobas Ampliprep/Cobas TaqMan (CAP), and Real-Time HCV (ART) in 903 samples of hepatitis C genotype 1 patients treated with dual (n=169) or telaprevir-based triple therapy (n=164) in three European countries. RESULTS: Overall, CAP and ART were in excellent agreement for the determination of HCV-RNA concentrations (mean difference 0.21 log10 IU/ml). For treatment-naïve patients treated with peginterferon-alfa and ribavirin a lower rate of undetectable HCV-RNA at week 4 (RVR) was observed for ART (9%) vs. CAP (16%). Although 11/27 (41%) of patients with shortened treatment (24weeks) had detectable HCV-RNA <12IU/ml by ART at week 4 none of these patients experienced virologic relapse after treatment cessation. In patients who received triple therapy, 67% and 37% had undetectable HCV-RNA at week 4 by CAP and ART, respectively. However, 18/31 (58%) eligible patients for shortened treatment based on CAP had detectable HCV-RNA by ART at week 4. Again, relapse was not observed in these patients. CONCLUSIONS: Lower rates of undetectable HCV-RNA at week 4 were observed with ART compared to CAP in patients treated with dual and triple therapies. For ART, detectable <12IU/ml HCV-RNA levels at week 4 may be sufficient as part of the criteria used for selecting patients who receive a shortened treatment regimen.
Authors: F Wiesmann; G Naeth; C Sarrazin; A Berger; R Kaiser; R Ehret; H Knechten; P Braun Journal: Med Microbiol Immunol Date: 2014-11-15 Impact factor: 3.402
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Authors: Benjamin Maasoumy; Bela Hunyady; Vincenza Calvaruso; Mihály Makara; Johannes Vermehren; Attila Haragh; Simone Susser; Birgit Bremer; Gavin Cloherty; Michael P Manns; Antonio Craxì; Heiner Wedemeyer; Christoph Sarrazin Journal: PLoS One Date: 2014-11-12 Impact factor: 3.240
Authors: F Wiesmann; G Naeth; A Berger; H H Hirsch; S Regenass; R S Ross; C Sarrazin; H Wedemeyer; H Knechten; P Braun Journal: Med Microbiol Immunol Date: 2015-12-14 Impact factor: 3.402