Clinical and virological predictors of sustained response with an interferon-based simeprevir regimen for patients with chronic genotype 1 hepatitis C virus infection

Gianpiero D'Offizi, Calogero Cammà, Chiara Taibi, Michael Schlag, Karin Weber, Maria Palma, Ralph De Masi, Katrien Janssen, James Witek, Raffaella Lionetti

Research output: Contribution to journalArticle

Abstract

Simeprevir plus peg-interferon/ribavirin (PR) is approved to treat chronic hepatitis C (HCV) genotype 1 (GT1) and GT4 infection. This study aimed to assess baseline and on-treatment the factors predictive of sustained virologic response 12-weeks post-treatment (SVR12) in patients receiving 12 weeks of simeprevir plus PR followed by 12 or 36 weeks of PR. Data from participants in four studies (QUEST-1, QUEST-2, ATTAIN and PROMISE) were pooled to examine the efficacy and safety of simeprevir+PR in HCV GT1 patients. The predictive power of baseline variables for SVR12 was assessed using univariate and multivariate logistic regression models while the relationship between early (Week 4) on-treatment response and SVR12 was analyzed by GT1 subtype and treatment experience. Data for 1160 patients were analyzed (overall SVR12: 71%). Baseline factors predictive of SVR12 were: IL28B CC genotype, GT1a/Q80K-negative, treatment-naïve/prior relapser, no cirrhosis, HCV-RNA =2,000,000IU/mL, albumin >42g/L, platelets >200x109/L. Patients with HCV GT1b (86%), IL28B CC genotype (87%), and treatment-naïve patients (83%) were predicted to achieve the highest SVR12 rates and rates of rapid virologic response. Week 4 early on-treatment response identified treatment-naïve and prior relapse patients likely to achieve SVR12. Patients likely to respond to simeprevir+PR can be identified using baseline factors. Early on-treatment response predicts treatment success.

Original languageEnglish
Pages (from-to)19-26
Number of pages8
JournalNew Microbiologica
Volume40
Issue number1
Publication statusPublished - Jan 1 2017

Keywords

  • Genotype 1
  • Hepatitis C
  • Interferon-based therapy
  • Simeprevir

ASJC Scopus subject areas

  • Microbiology (medical)

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