Z Gastroenterol 2015; 53 - A5_8
DOI: 10.1055/s-0034-1397212

Baseline predictors of an early virologic response (EVR) in previously untreated patients undergoing boceprevir (BOC) triple therapy for HCV genotype 1 infection in German real-life

P Buggisch 1, H Löhr 2, G Teuber 3, H Steffens 4, M Kraus 5, C John 6, P Geyer 7, B Weber 8, T Witthöft 9, A Herrmann 10, M Hoesl 11, U Naumann 12, E Zehnter 13, D Hartmann 14, B Dreher 14, M Bilzer 14
  • 1IFI Institute, Hamburg, Germany
  • 2Gastroenterological Practice, Wiesbaden, Germany
  • 3Gastroenterological Practice, Frankfurt, Germany
  • 4Practice of internal Medicine, Berlin, Germany
  • 5Klinium Burghausen, Burghausen, Germany
  • 6Practice of Internal Medicine, Berlin, Germany
  • 7Gastroenterological Practice, Fulda, Germany
  • 8Competence Center Addiction, Kassel, Germany
  • 9Gastroenterological Practice, Stade, Germany
  • 10Friedrich-Schiller-University, Jena, Germany
  • 11Gastroenterological Practice, Nuremberg, Germany
  • 12Center of Medicine, Berlin, Germany
  • 13Gastroenterological Practice, Dortmund, Germany
  • 14MSD Pharma GmbH, Haar, Germany

Background: The achievement of EVR during triple therapy of chronic HCV genotype 1 (G1) infection with BOC has been identified as predictor of high SVR rates of up to 90% as well as a predictor to shorten triple therapy to 24 weeks. The present interim analysis of the NOVUS observational study was aimed to investigate EVR during BOC triple therapy in German real-life and to identify baseline predictors of EVR.

Methods: From April 2012 until January 2014, 536 patients with G1 infection were recruited in the ongoing NOVUS study by 97 practices and hospitals in Germany. Patients were treated with pegylated interferons (PegIFN) and ribavirin (RBV) together with BOC for 24 to 44 weeks after a 4 weeks lead-in period with PegIFN/RBV. The present interim analysis was restricted to 222 previously untreated patients with documented HCV-RNA levels at treatment week (TW) 8.

Results: The frequency of EVR was 71% (158/222). Achievement of EVR was significantly associated with the following baseline factors: age < 50 years (vs. > 50 years): 76.3% vs. 62.7%, p = 0.0303; low viral load (LVL) < 400.000 IU/mL (vs. > 400.000 IU/mL): 84.5% vs. 64.7%, p = 0.0024; gamma-GT levels within the normal range (vs. elevated): 82.0% vs. 57.4%, p < 0.0001; ferritin levels < 300 µg/L (vs. > 300 µg/L): 71.6% vs. 41.6%, p = 0.0088; glomerular filtration rate (eGFR) > 90 mL/min per 1.73 m2 (vs. eGFR 60 – 90): 73.2% vs. 57.4%, p = 0.0416. In contrast, no association with the achievement of EVR was found for gender (male vs. female), ALT and glucose levels (normal range vs. elevated), genotype 1 subtypes (1a vs. 1b) or APRI score (< vs. > 0.7). When a multivariate logistic regression model was used, viral load and gamma-GT levels at baseline were identified as independent predictors of EVR: baseline viral load (< vs > 400.000 IU/mL): OR 2.87 (CI 1.04 – 5.70; p = 0.040); gamma-GT (normal vs elevated): OR 2.87 (CI 1.37 – 6.02; p = 0.0053). In line with this observation an EVR rate of 93% was achieved in patients with LVL < 400.000 IU/mL together with normal gamma-GT levels at baseline.

Conclusions: In German real-life 71% of previously untreated patients undergoing BOC triple therapy for HCV G1 infection achieve a prognostic favorable EVR. LVL < 400.000 IU/mL and normal gamma-GT levels are independent baseline predictors of high EVR rates > 80% or EVR rates up to 93% when combined. The advantage to identify patients with high virologic response rates to BOC triple therapy by standard laboratory parameters in real-life may be helpful for patients and physicians and in addition, appears to be cost-effective.

Corresponding author: Bilzer, Manfred

E-Mail: manfred.bilzer@bilzer-consulting.de