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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, Vol. 40, No. 11, 2020, p. 2660-2671.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Dietz, J, Vermehren, J, Matschenz, K, Buggisch, P, Klinker, H, Schulze Zur Wiesch, J, Hinrichsen, H, Peiffer, K-H, Graf, C, Discher, T, Trauth, J, Schattenberg, JM, Piecha, F, Mauss, S, Niederau, C, Müller, T, Neumann-Haefelin, C, Berg, CP, Zeuzem, S, Sarrazin, C & European HCV Resistance Study Group 2020, 'Treatment outcomes in hepatitis C virus genotype 1a infected patients with and without baseline NS5A resistance-associated substitutions', LIVER INT, vol. 40, no. 11, pp. 2660-2671. https://doi.org/10.1111/liv.14591

APA

Dietz, J., Vermehren, J., Matschenz, K., Buggisch, P., Klinker, H., Schulze Zur Wiesch, J., Hinrichsen, H., Peiffer, K-H., Graf, C., Discher, T., Trauth, J., Schattenberg, J. M., Piecha, F., Mauss, S., Niederau, C., Müller, T., Neumann-Haefelin, C., Berg, C. P., Zeuzem, S., ... European HCV Resistance Study Group (2020). Treatment outcomes in hepatitis C virus genotype 1a infected patients with and without baseline NS5A resistance-associated substitutions. LIVER INT, 40(11), 2660-2671. https://doi.org/10.1111/liv.14591

Vancouver

Dietz J, Vermehren J, Matschenz K, Buggisch P, Klinker H, Schulze Zur Wiesch J et al. Treatment outcomes in hepatitis C virus genotype 1a infected patients with and without baseline NS5A resistance-associated substitutions. LIVER INT. 2020;40(11):2660-2671. https://doi.org/10.1111/liv.14591

Bibtex

@article{e344179bc9c5464182003aa070254a27,
title = "Treatment outcomes in hepatitis C virus genotype 1a infected patients with and without baseline NS5A resistance-associated substitutions",
abstract = "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-na{\"i}ve 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.",
author = "Julia Dietz and Johannes Vermehren and Katrin Matschenz and Peter Buggisch and Hartwig Klinker and {Schulze Zur Wiesch}, Julian and Holger Hinrichsen and Kai-Henrik Peiffer and Christiana Graf and Thomas Discher and Janina Trauth and Schattenberg, {J{\"o}rn M} and Felix Piecha and Stefan Mauss and Claus Niederau and Tobias M{\"u}ller and Christoph Neumann-Haefelin and Berg, {Christoph P} and Stefan Zeuzem and Christoph Sarrazin and {European HCV Resistance Study Group}",
note = "This article is protected by copyright. All rights reserved.",
year = "2020",
doi = "10.1111/liv.14591",
language = "English",
volume = "40",
pages = "2660--2671",
journal = "LIVER INT",
issn = "1478-3223",
publisher = "Wiley-Blackwell",
number = "11",

}

RIS

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 -