Z Gastroenterol 2015; 53 - A2_21
DOI: 10.1055/s-0035-1567993

Treatment of chronic HCV Genotype 1 infection with Boceprevir in German real-life:The impact of SVR on initially elevated and initially normal serum alanine aminotransferase (ALT) and gamma-glutamyl transpeptidase (GGT) levels

P Buggisch 1, H Löhr 2, G Teuber 3, H Steffens 4, M Kraus 5, P Geyer 6, B Weber 7, T Witthöft 8, U Naumann 9, E Zehnter 10, D Hartmann 11, B Dreher 11, M Bilzer 11
  • 1ifi Institute, Hamburg, Germany
  • 2Gastroenterological Practice, Wiesbaden, Germany
  • 3Gastroenterological Practice, Frankfurt, Germany
  • 4Practice of internal Medicine, Berlin, Germany
  • 5Klinium Burghausen, Medical Department II, Burghausen, Germany
  • 6Gastroenterological Practice, Fulda, Germany
  • 7Competence Center Addiction, Kassel, Germany
  • 8Gastroenterological Practice, Stade, Germany
  • 9Center of Medicine, Berlin, Germany
  • 10Gastroenterological Practice, Dortmund, Germany
  • 11MSD Pharma GmbH, Haar, Germany

Background: Patients (pts) with chronic HCV G1 infection may present with normal or elevated serum ALT or GGT levels. The aim of the present analysis was to investigate the effect of successful treatment of chronic HCV G1 infection with boceprevir (BOC) triple therapy on initially elevated and initially normal ALT and GGT levels.

Methods: From April 2012 until January 2014, 536 pts with HCV G1 infection were recruited in the ongoing NOVUS observational study by 97 practices and hospitals in Germany. Pts 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 144 treatment-naïve pts and 60 previously treated pts who achieved a sustained virologic response (SVR) 24 weeks after termination of HCV treatment.

Results: 80% (115/144) and 40% (56/139) of treatment-naive pts presented with elevated ALT and GGT levels before HCV therapy. Compared to treatment-naïve pts, a similar frequency of ALT elevations (72%; 43/60) was found in previously treated pts while GGT elevations occurred more frequently (59%; 34/58; P = 0.019). Achieving SVR resulted in a normalization of initially elevated ALT and GGT levels in 94% and 91% of treatment-naive pts 24 weeks after termination of triple therapy. Comparable and statistically not different results were observed in previously treated pts with SVR who achieved normalization of ALT and AST in 95% and 96%, respectively. In treatment-naïve pts with normal serum ALT and GGT levels at baseline achievement of SVR was associated with a significant (P < 0.0001) ALT and GGT decline by 33% and 38%. Similar results showing a significant ALT and GGT decline by 49% (P < 0.0001) and 36% (P = 0.0005) were obtained in previously treated pts with initially normal ALT and GGT levels.

Conclusions: Achievement of SVR following treatment of chronic HCV G1 infection with BOC in German real-world is accompanied by a normalization of initially elevated ALT and GGT levels in more than 90% of previously untreated and previously treated pts. In addition, achievement of SVR results in a significant decline of initially normal ALT and GGT values. Whether this decline reflects reduction of liver cell injury despite initially normal ALT and GGT levels remains to be investigated.

Corresponding author: Bilzer, Manfred

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