Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis

Tarik Asselah; Hendrik Reesink; Jan Gerstoft; Victor de Ledinghen; Paul J Pockros; Michael Robertson; Peggy Hwang; Ernest Asante-Appiah; Janice Wahl; Bach-Yen Nguyen; Eliav Barr; Rohit Talwani; Lawrence Serfaty

doi:10.1111/liv.13727

Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis

Tarik Asselah, Hendrik Reesink, Jan Gerstoft, Victor de Ledinghen, Paul J Pockros, Michael Robertson, Peggy Hwang, Ernest Asante-Appiah, Janice Wahl, Bach-Yen Nguyen, Eliav Barr, Rohit Talwani, Lawrence Serfaty

Department of Clinical Medicine

19 Citations (Scopus)

Abstract

BACKGROUND & AIMS: The aim of this integrated analysis was to assess the efficacy of the once-daily combination of elbasvir 50 mg and grazoprevir 100 mg, with and without ribavirin in HCV genotype 4 (GT4)-infected participants enrolled in the Phase 2/3 clinical programme with elbasvir/grazoprevir.

METHODS: Treatment-naïve and treatment-experienced participants 18 years of age or older with chronic HCV GT4 infection and baseline HCV RNA ≥10 000 IU/mL were included in the analysis. The analysis population was the full analysis set (FAS; all participants who received at least 1 dose of study medication) and a total of 155 HCV GT4 participants were evaluated. The primary endpoint was sustained virologic response at week 12 (SVR12; HCV RNA less than the lower limit of quantitation at 12 weeks after the completion of study therapy).

RESULTS: Overall, among GT4-infected participants treated with 12 or 16 weeks of elbasvir/grazoprevir ± ribavirin, the SVR12 efficacy rates were 96.4% (107/111) in treatment-naïve participants and 88.6% (39/44) in treatment-experienced participants. The SVR12 rates were 96.0% (97/101) in treatment-naïve participants treated with 12 weeks of elbasvir/grazoprevir and 100% (8/8) in treatment-experienced participants treated with 16 weeks of elbasvir/grazoprevir plus ribavirin. Efficacy was not impacted by GT4 subtype.

CONCLUSIONS: The regimens of 12 weeks of elbasvir/grazoprevir without ribavirin, and 16 weeks of elbasvir/grazoprevir plus ribavirin, were efficacious in HCV GT4-infected treatment-naïve and treatment-experienced participants respectively. Baseline NS5A resistance-associated substitutions did not impact the efficacy of elbasvir/grazoprevir in GT4-infected participants.

Original language	English
Journal	Liver International
Volume	38
Issue number	9
Pages (from-to)	1583-1591
Number of pages	9
ISSN	1478-3223
DOIs	https://doi.org/10.1111/liv.13727
Publication status	Published - Sept 2018

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Asselah, T., Reesink, H., Gerstoft, J., de Ledinghen, V., Pockros, P. J., Robertson, M., Hwang, P., Asante-Appiah, E., Wahl, J., Nguyen, B.-Y., Barr, E., Talwani, R., & Serfaty, L. (2018). Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis. Liver International, 38(9), 1583-1591. https://doi.org/10.1111/liv.13727

Asselah, T, Reesink, H, Gerstoft, J, de Ledinghen, V, Pockros, PJ, Robertson, M, Hwang, P, Asante-Appiah, E, Wahl, J, Nguyen, B-Y, Barr, E, Talwani, R & Serfaty, L 2018, 'Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis', Liver International, vol. 38, no. 9, pp. 1583-1591. https://doi.org/10.1111/liv.13727

@article{66d320e36ac94f6db8ce96e723e2e000,

title = "Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis",

abstract = "BACKGROUND & AIMS: The aim of this integrated analysis was to assess the efficacy of the once-daily combination of elbasvir 50 mg and grazoprevir 100 mg, with and without ribavirin in HCV genotype 4 (GT4)-infected participants enrolled in the Phase 2/3 clinical programme with elbasvir/grazoprevir.METHODS: Treatment-na{\"i}ve and treatment-experienced participants 18 years of age or older with chronic HCV GT4 infection and baseline HCV RNA ≥10 000 IU/mL were included in the analysis. The analysis population was the full analysis set (FAS; all participants who received at least 1 dose of study medication) and a total of 155 HCV GT4 participants were evaluated. The primary endpoint was sustained virologic response at week 12 (SVR12; HCV RNA less than the lower limit of quantitation at 12 weeks after the completion of study therapy).RESULTS: Overall, among GT4-infected participants treated with 12 or 16 weeks of elbasvir/grazoprevir ± ribavirin, the SVR12 efficacy rates were 96.4% (107/111) in treatment-na{\"i}ve participants and 88.6% (39/44) in treatment-experienced participants. The SVR12 rates were 96.0% (97/101) in treatment-na{\"i}ve participants treated with 12 weeks of elbasvir/grazoprevir and 100% (8/8) in treatment-experienced participants treated with 16 weeks of elbasvir/grazoprevir plus ribavirin. Efficacy was not impacted by GT4 subtype.CONCLUSIONS: The regimens of 12 weeks of elbasvir/grazoprevir without ribavirin, and 16 weeks of elbasvir/grazoprevir plus ribavirin, were efficacious in HCV GT4-infected treatment-na{\"i}ve and treatment-experienced participants respectively. Baseline NS5A resistance-associated substitutions did not impact the efficacy of elbasvir/grazoprevir in GT4-infected participants.",

author = "Tarik Asselah and Hendrik Reesink and Jan Gerstoft and {de Ledinghen}, Victor and Pockros, {Paul J} and Michael Robertson and Peggy Hwang and Ernest Asante-Appiah and Janice Wahl and Bach-Yen Nguyen and Eliav Barr and Rohit Talwani and Lawrence Serfaty",

year = "2018",

month = sep,

doi = "10.1111/liv.13727",

language = "English",

volume = "38",

pages = "1583--1591",

journal = "Liver International",

issn = "1478-3223",

publisher = "Wiley-Blackwell",

number = "9",

}

TY - JOUR

T1 - Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection

T2 - A pooled analysis

AU - Asselah, Tarik

AU - Reesink, Hendrik

AU - Gerstoft, Jan

AU - de Ledinghen, Victor

AU - Pockros, Paul J

AU - Robertson, Michael

AU - Hwang, Peggy

AU - Asante-Appiah, Ernest

AU - Wahl, Janice

AU - Nguyen, Bach-Yen

AU - Barr, Eliav

AU - Talwani, Rohit

AU - Serfaty, Lawrence

PY - 2018/9

Y1 - 2018/9

N2 - BACKGROUND & AIMS: The aim of this integrated analysis was to assess the efficacy of the once-daily combination of elbasvir 50 mg and grazoprevir 100 mg, with and without ribavirin in HCV genotype 4 (GT4)-infected participants enrolled in the Phase 2/3 clinical programme with elbasvir/grazoprevir.METHODS: Treatment-naïve and treatment-experienced participants 18 years of age or older with chronic HCV GT4 infection and baseline HCV RNA ≥10 000 IU/mL were included in the analysis. The analysis population was the full analysis set (FAS; all participants who received at least 1 dose of study medication) and a total of 155 HCV GT4 participants were evaluated. The primary endpoint was sustained virologic response at week 12 (SVR12; HCV RNA less than the lower limit of quantitation at 12 weeks after the completion of study therapy).RESULTS: Overall, among GT4-infected participants treated with 12 or 16 weeks of elbasvir/grazoprevir ± ribavirin, the SVR12 efficacy rates were 96.4% (107/111) in treatment-naïve participants and 88.6% (39/44) in treatment-experienced participants. The SVR12 rates were 96.0% (97/101) in treatment-naïve participants treated with 12 weeks of elbasvir/grazoprevir and 100% (8/8) in treatment-experienced participants treated with 16 weeks of elbasvir/grazoprevir plus ribavirin. Efficacy was not impacted by GT4 subtype.CONCLUSIONS: The regimens of 12 weeks of elbasvir/grazoprevir without ribavirin, and 16 weeks of elbasvir/grazoprevir plus ribavirin, were efficacious in HCV GT4-infected treatment-naïve and treatment-experienced participants respectively. Baseline NS5A resistance-associated substitutions did not impact the efficacy of elbasvir/grazoprevir in GT4-infected participants.

AB - BACKGROUND & AIMS: The aim of this integrated analysis was to assess the efficacy of the once-daily combination of elbasvir 50 mg and grazoprevir 100 mg, with and without ribavirin in HCV genotype 4 (GT4)-infected participants enrolled in the Phase 2/3 clinical programme with elbasvir/grazoprevir.METHODS: Treatment-naïve and treatment-experienced participants 18 years of age or older with chronic HCV GT4 infection and baseline HCV RNA ≥10 000 IU/mL were included in the analysis. The analysis population was the full analysis set (FAS; all participants who received at least 1 dose of study medication) and a total of 155 HCV GT4 participants were evaluated. The primary endpoint was sustained virologic response at week 12 (SVR12; HCV RNA less than the lower limit of quantitation at 12 weeks after the completion of study therapy).RESULTS: Overall, among GT4-infected participants treated with 12 or 16 weeks of elbasvir/grazoprevir ± ribavirin, the SVR12 efficacy rates were 96.4% (107/111) in treatment-naïve participants and 88.6% (39/44) in treatment-experienced participants. The SVR12 rates were 96.0% (97/101) in treatment-naïve participants treated with 12 weeks of elbasvir/grazoprevir and 100% (8/8) in treatment-experienced participants treated with 16 weeks of elbasvir/grazoprevir plus ribavirin. Efficacy was not impacted by GT4 subtype.CONCLUSIONS: The regimens of 12 weeks of elbasvir/grazoprevir without ribavirin, and 16 weeks of elbasvir/grazoprevir plus ribavirin, were efficacious in HCV GT4-infected treatment-naïve and treatment-experienced participants respectively. Baseline NS5A resistance-associated substitutions did not impact the efficacy of elbasvir/grazoprevir in GT4-infected participants.

U2 - 10.1111/liv.13727

DO - 10.1111/liv.13727

M3 - Journal article

C2 - 29461687

SN - 1478-3223

VL - 38

SP - 1583

EP - 1591

JO - Liver International

JF - Liver International

IS - 9

ER -

Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis

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