Baseline factors and early viral response (week 4) to antiviral therapy with peginterferon and ribavirin for predicting sustained virologic response in patients infected with hepatitis C virus genotype 1: A multicenter study

2012 ◽  
Vol 85 (1) ◽  
pp. 65-70 ◽  
Author(s):  
Hidenori Toyoda ◽  
Takashi Kumada ◽  
Noritomo Shimada ◽  
Koichi Takaguchi ◽  
Tatsuya Ide ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Multicenter Study ◽  
Virologic Response ◽  
Genotype 1 ◽  
Virus Genotype ◽  
Viral Response ◽  
Early Viral Response ◽  
Baseline Factors ◽  
Peginterferon And Ribavirin

Su1440 Multicenter Study Evaluating Prevalence of Genotypic Resistance-Associated Variants of Hepatitis C Virus Genotype 1 in Ledipasvir/Sofosbuvir Relapsers

2016 ◽  
Vol 150 (4) ◽  
pp. S1100
Author(s):  
Omar Mousa ◽  
Bashar Aqel ◽  
Michael D. Leise ◽  
Joseph D. Yao ◽  
Kymberly D. Watt ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Multicenter Study ◽  
Genotype 1 ◽  
Virus Genotype ◽  
Genotypic Resistance

scholarly journals Effectiveness and safety of first-generation protease inhibitors in real-world patients with hepatitis C virus genotype 1 infection in Brazil: a multicenter study

Clinics ◽  
2017 ◽  
Vol 72 (6) ◽  
pp. 378-385 ◽  
Author(s):  
LA Callefi ◽  
CA Villela-Nogueira ◽  
SB Tenore ◽  
D Carnaúba-Júnior ◽  
HS Coelho ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Protease Inhibitors ◽  
Multicenter Study ◽  
Real World ◽  
First Generation ◽  
Genotype 1 ◽  
Virus Genotype

scholarly journals Randomized trial of peginterferon alfa-2b and ribavirin for 48 or 72 weeks in patients with hepatitis C virus genotype 1 and slow virologic response

Hepatology ◽  
2010 ◽  
Vol 52 (4) ◽  
pp. 1201-1207 ◽  
Author(s):  
Maria Buti ◽  
Yoav Lurie ◽  
Natalia G. Zakharova ◽  
Natalia P. Blokhina ◽  
Andrzej Horban ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Randomized Trial ◽  
Virologic Response ◽  
Genotype 1 ◽  
Virus Genotype ◽  
Peginterferon Alfa

scholarly journals Clinical Implications of Detectable Baseline Hepatitis C Virus-Genotype 1 NS3/4A-Protease Variants on the Efficacy of Boceprevir Combined With Peginterferon/Ribavirin

2014 ◽  
Vol 1 (2) ◽  
Author(s):  
John A. Howe ◽  
Jianmin Long ◽  
Stuart Black ◽  
Robert Chase ◽  
Patricia McMonagle ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Sustained Virologic Response ◽  
Virologic Failure ◽  
Virologic Response ◽  
Phase Iii ◽  
Hcv Rna ◽  
Genotype 1 ◽  
Virus Genotype ◽  
The Impact

Abstract Background.  We analyzed the impact of pretreatment variants conferring boceprevir-resistance on sustained virologic response (SVR) rates achieved with boceprevir plus peginterferon-α/ribavirin (P/R) for hepatitis C virus (HCV)-genotype-1 infection. Methods.  NS3-protease-polymorphisms emerging coincident with virologic failure on boceprevir/P/R regimens were identified as resistance-associated variants (RAVs). Baseline samples pooled from 6 phase II or phase III clinical trials were analyzed for RAVs by population sequencing. Interferon (IFN)-responsiveness was predefined as >1 log reduction in HCV-RNA level during the initial 4-week lead-in treatment with P/R before boceprevir was added. The effective boceprevir-concentration inhibiting RAV growth by 50% (EC50) was determined using a replicon assay relative to the wild-type referent. Results.  Sequencing was performed in 2241 of 2353 patients (95.2%) treated with boceprevir. At baseline, RAVs were detected in 178 patients (7.9%), including 153 of 1498 genotype-1a infections (10.2%) and 25 of 742 genotype-1b infections (3.4%) (relative risk, 3.03; 95% confidence interval [CI], [2.01, 4.58]). For IFN-responders, SVR24 (SVR assessed 24 weeks after discontinuation of all study medications) rates were 78% and 76% with or without RAVs detected at baseline, respectively. For the 510 poor IFN-responders, SVR24 rates were 8 of 36 subjects (22.2% [11.7%, 38.1%]) when baseline RAVs were detected vs 174 of 474 subjects (36.7% [32.5%, 41.1%]) when baseline RAVs were not detected (relative likelihood of SVR24 [95% CI], 0.61 [0.32, 1.05]). Sustained virologic response was achieved in 7 of 8 (87.5%) IFN-nonresponders with baseline variants exhibiting ≤2-fold increased EC50 for boceprevir in a replicon assay, whereas only 1 of 15 (7%) IFN-nonresponders with baseline RAVs associated with ≥3-fold increased EC50 achieved SVR. Conclusions.  Baseline protease-variants appear to negatively impact SVR rates for boceprevir/P/R regimens only when associated with decreased boceprevir susceptibility in vitro after a poor IFN-response during the lead-in period.

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