Treatment outcomes in hepatitis C virus genotype 1a infected patients with and without baseline NS5A resistance-associated substitutions
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Treatment outcomes in hepatitis C virus genotype 1a infected patients with and without baseline NS5A resistance-associated substitutions. / Dietz, Julia; Vermehren, Johannes; Matschenz, Katrin; Buggisch, Peter; Klinker, Hartwig; Schulze Zur Wiesch, Julian; Hinrichsen, Holger; Peiffer, Kai-Henrik; Graf, Christiana; Discher, Thomas; Trauth, Janina; Schattenberg, Jörn M; Piecha, Felix; Mauss, Stefan; Niederau, Claus; Müller, Tobias; Neumann-Haefelin, Christoph; Berg, Christoph P; Zeuzem, Stefan; Sarrazin, Christoph; European HCV Resistance Study Group.
in: LIVER INT, Jahrgang 40, Nr. 11, 2020, S. 2660-2671.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Treatment outcomes in hepatitis C virus genotype 1a infected patients with and without baseline NS5A resistance-associated substitutions
AU - Dietz, Julia
AU - Vermehren, Johannes
AU - Matschenz, Katrin
AU - Buggisch, Peter
AU - Klinker, Hartwig
AU - Schulze Zur Wiesch, Julian
AU - Hinrichsen, Holger
AU - Peiffer, Kai-Henrik
AU - Graf, Christiana
AU - Discher, Thomas
AU - Trauth, Janina
AU - Schattenberg, Jörn M
AU - Piecha, Felix
AU - Mauss, Stefan
AU - Niederau, Claus
AU - Müller, Tobias
AU - Neumann-Haefelin, Christoph
AU - Berg, Christoph P
AU - Zeuzem, Stefan
AU - Sarrazin, Christoph
AU - European HCV Resistance Study Group
N1 - This article is protected by copyright. All rights reserved.
PY - 2020
Y1 - 2020
N2 - BACKGROUND&AIMS: The presence of baseline resistance-associated substitutions (RASs) reduced sustained virologic response (SVR) rates in chronic hepatitis C virus (HCV) genotype 1a infected patients treated with Elbasvir/Grazoprevir (EBR/GZR). This study aimed to evaluate the frequency of NS5A RASs and treatment outcomes in patients for whom EBR/GZR was intended.METHODS: We sequenced NS5A in 832 samples from German genotype1a-infected DAA-naïve patients population-based, which were collected in the European Resistance Database. Treatment outcomes and clinical parameters were evaluated in 519 of these patients retrospectively.RESULTS: Overall, 6.5% of patients harbored EBR-specific NS5A RASs at baseline, including Q30H/R (3.3%), L31M (1.8%), Y93H (1.6%) and other individual variants. Antiviral treatment, including EBR/GZR, was initiated in 88% of patients. In the absence of RASs, the majority of patients received EBR/GZR for 12 weeks (57%) and the SVR rate was 97% compared to 99% SVR achieved using other DAA regimens (LDV/SOF±RBV, G/P, PrOD+RBV, VEL/SOF). Various regimens were used in the presence of RASs and SVR rates were high following treatment with LDV/SOF (100%), G/P (83%), PrOD/RBV (100%), VEL/SOF (100%), SMV/SOF (100%) and EBR/GZR+RBV for 16 weeks (100%). However, two patients received EBR/GZR for 16 weeks without RBV and one relapsed.CONCLUSIONS: EBR/GZR treatment with or without RBV for 12 or 16 weeks according to a baseline RAS analysis was highly effective with ≥97% SVR in patients with genotype 1a. EBR/GZR without RBV should be avoided in patients with RASs. High SVR rates were also achieved using other 8 or 12 weeks DAA regimens.
AB - BACKGROUND&AIMS: The presence of baseline resistance-associated substitutions (RASs) reduced sustained virologic response (SVR) rates in chronic hepatitis C virus (HCV) genotype 1a infected patients treated with Elbasvir/Grazoprevir (EBR/GZR). This study aimed to evaluate the frequency of NS5A RASs and treatment outcomes in patients for whom EBR/GZR was intended.METHODS: We sequenced NS5A in 832 samples from German genotype1a-infected DAA-naïve patients population-based, which were collected in the European Resistance Database. Treatment outcomes and clinical parameters were evaluated in 519 of these patients retrospectively.RESULTS: Overall, 6.5% of patients harbored EBR-specific NS5A RASs at baseline, including Q30H/R (3.3%), L31M (1.8%), Y93H (1.6%) and other individual variants. Antiviral treatment, including EBR/GZR, was initiated in 88% of patients. In the absence of RASs, the majority of patients received EBR/GZR for 12 weeks (57%) and the SVR rate was 97% compared to 99% SVR achieved using other DAA regimens (LDV/SOF±RBV, G/P, PrOD+RBV, VEL/SOF). Various regimens were used in the presence of RASs and SVR rates were high following treatment with LDV/SOF (100%), G/P (83%), PrOD/RBV (100%), VEL/SOF (100%), SMV/SOF (100%) and EBR/GZR+RBV for 16 weeks (100%). However, two patients received EBR/GZR for 16 weeks without RBV and one relapsed.CONCLUSIONS: EBR/GZR treatment with or without RBV for 12 or 16 weeks according to a baseline RAS analysis was highly effective with ≥97% SVR in patients with genotype 1a. EBR/GZR without RBV should be avoided in patients with RASs. High SVR rates were also achieved using other 8 or 12 weeks DAA regimens.
U2 - 10.1111/liv.14591
DO - 10.1111/liv.14591
M3 - SCORING: Journal article
C2 - 32640072
VL - 40
SP - 2660
EP - 2671
JO - LIVER INT
JF - LIVER INT
SN - 1478-3223
IS - 11
ER -