Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis
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Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection : A pooled analysis. / Asselah, Tarik; Reesink, Hendrik; Gerstoft, Jan; de Ledinghen, Victor; Pockros, Paul J; Robertson, Michael; Hwang, Peggy; Asante-Appiah, Ernest; Wahl, Janice; Nguyen, Bach-Yen; Barr, Eliav; Talwani, Rohit; Serfaty, Lawrence.
In: Liver International, Vol. 38, No. 9, 2018, p. 1583-1591.Research output: Contribution to journal › Journal article › Research › peer-review
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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
Y1 - 2018
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
VL - 38
SP - 1583
EP - 1591
JO - Liver International
JF - Liver International
SN - 1478-3223
IS - 9
ER -
ID: 218655155