BACKGROUND: Early on-treatment virological response is one of the most important predictors for sustained virological response (SVR) to treatment of chronic hepatitis C virus (HCV) genotype 1 infection with triple therapy including HCV protease inhibitors (PI). Treatment duration (24 vs. 48 weeks) is based on HCV RNA results at weeks 4 and 12 of PI therapy when HCV RNA must be 'undetectable' to allow shorter therapy. AIM: To analyse the reliability of HCV RNA measurements at key decision time points (weeks 4 and 12) and the predictive value of concordant or discordant assay results for SVR. METHODS: Weeks 4 and 12 samples of patients receiving telaprevir-containing triple therapy were initially tested with the AmpliPrep/COBAS-TaqMan_HCV-Test-v1.0 (limit of detection; LOD = 15IU/mL) and retested with the AmpliPrep/COBAS-TaqMan_HCV-Test-v2.0 (LOD = 15IU/mL) and the High_Pure/COBAS-TaqMan_HCV-Test-v2.0 (LOD = 20IU/mL). RESULTS: Concordance among the three test results in classifying samples as HCV RNA 'undetectable' or 'detectable' was only 55% at week 4, but 85% at week 12. Retesting of 'undetectable' week 4 samples with the respective other assays revealed positive HCV RNA results in 32-50%. In 30%, HCV RNA was 'undetectable' by all three tests at week 4 and all of these patients achieved SVR. In contrast, treatment failure occurred in 62% of patients with at least one 'detectable' result, including cases with one or two other 'undetectable' tests at week 4. CONCLUSIONS: A single 'undetectable' HCV RNA result at week 4 is not always associated with achieving SVR. Repeated testing in difficult-to-treat patients may identify those at risk for treatment failure.
BACKGROUND: Early on-treatment virological response is one of the most important predictors for sustained virological response (SVR) to treatment of chronic hepatitis C virus (HCV) genotype 1 infection with triple therapy including HCV protease inhibitors (PI). Treatment duration (24 vs. 48 weeks) is based on HCV RNA results at weeks 4 and 12 of PI therapy when HCV RNA must be 'undetectable' to allow shorter therapy. AIM: To analyse the reliability of HCV RNA measurements at key decision time points (weeks 4 and 12) and the predictive value of concordant or discordant assay results for SVR. METHODS: Weeks 4 and 12 samples of patients receiving telaprevir-containing triple therapy were initially tested with the AmpliPrep/COBAS-TaqMan_HCV-Test-v1.0 (limit of detection; LOD = 15IU/mL) and retested with the AmpliPrep/COBAS-TaqMan_HCV-Test-v2.0 (LOD = 15IU/mL) and the High_Pure/COBAS-TaqMan_HCV-Test-v2.0 (LOD = 20IU/mL). RESULTS: Concordance among the three test results in classifying samples as HCV RNA 'undetectable' or 'detectable' was only 55% at week 4, but 85% at week 12. Retesting of 'undetectable' week 4 samples with the respective other assays revealed positive HCV RNA results in 32-50%. In 30%, HCV RNA was 'undetectable' by all three tests at week 4 and all of these patients achieved SVR. In contrast, treatment failure occurred in 62% of patients with at least one 'detectable' result, including cases with one or two other 'undetectable' tests at week 4. CONCLUSIONS: A single 'undetectable' HCV RNA result at week 4 is not always associated with achieving SVR. Repeated testing in difficult-to-treat patients may identify those at risk for treatment failure.
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
Authors: R K Sterling; A Kuo; V K Rustgi; M S Sulkowski; T G Stewart; J M Fenkel; H El-Genaidi; M A Mah'moud; G M Abraham; P W Stewart; L Akushevich; D R Nelson; M W Fried; A M Di Bisceglie Journal: Aliment Pharmacol Ther Date: 2015-01-28 Impact factor: 8.171
Authors: V Saxena; M M Manos; H S Yee; L Catalli; E Wayne; R C Murphy; V A Shvachko; M P Pauly; J Chua; A Monto; N A Terrault Journal: Aliment Pharmacol Ther Date: 2014-03-24 Impact factor: 8.171
Authors: Robert Strassl; Karoline Rutter; Albert Friedrich Stättermayer; Sandra Beinhardt; Michael Kammer; Harald Hofer; Peter Ferenci; Theresia Popow-Kraupp Journal: PLoS One Date: 2015-08-14 Impact factor: 3.240
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: Benjamin Maasoumy; Birgit Bremer; Patrick Lehmann; Ed G Marins; Véronique Michel-Treil; Christian O Simon; Merlin Njoya; Markus Cornberg; Ellen Paxinos; Michael P Manns; Johannes Vermehren; Christoph Sarrazin; Ji Yeon Sohn; Yunjung Cho; Heiner Wedemeyer Journal: Therap Adv Gastroenterol Date: 2017-08-07 Impact factor: 4.409