Z Gastroenterol 2015; 53 - KG147
DOI: 10.1055/s-0035-1559173

Serum gamma-glutamyl transferase (GGT) levels within the normal range are associated with a high SVR rate of 85% in treatment-naive patients undergoing Boceprevir triple therapy for HCV genotype 1 (G1) infection in German real-world

P Buggisch 1, H Löhr 2, G Teuber 2, H Steffens 3, M Kraus 4, C John 3, P Geyer 2, B Weber 5, T Witthöft 2, A Herrmann 6, M Hoesl 2, U Naumann 7, E Zehnter 2, D Hartmann 8, B Dreher 8, M Bilzer 8
  • 1ifi Institut für interdisziplinäre Medizin, Hamburg, Deutschland
  • 2Gastroenterological Practice, Wiesbaden, Deutschland
  • 3Practice of Internal Medicine, Berlin, Deutschland
  • 4Klinikum Burghausen, Department II, Burghausen, Deutschland
  • 5Competence Center Addiction, Kassel, Deutschland
  • 6Friedrich-Schiller-University, Jena, Deutschland
  • 7Praxiszentrum Kaiserdamm, Berlin, Deutschland
  • 8MSD Sharp & Dohme GmbH, Haar, Deutschland

Background: A considerable number of patients (pts) with chronic HCV G1 infection will present with elevated serum GGT levels. However, the impact of GGT elevation on virologic response to boceprevir (BOC) triple therapy has not been investigated until now and was therefore the aim of the present interim analysis of the German NOVUS observational study.

Methods: From April 2012 until January 2014, 536 pts with G1 infection were recruited in the ongoing NOVUS 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 260 previously untreated pts with documented GGT levels at baseline.

Results: 135 pts (52%) with normal GGT and 125 pts (48%) with elevated GGT levels at baseline had the following characteristics (normal vs. elevated GGT): Mean age: 44 vs. 46 years; male pts: 50 vs. 68% (P = 0.003); BMI: 26.0 vs. 27.3 kg/m2 (P = 0.04); elevated ALT: 68% vs. 93% (P 400,000 IU/mL: 62% vs. 75% (P = 0.03); HCV G1a: 28% vs. 47% (P = 0.009); liver cirrhosis: 3% vs. 7%; opioid substitution: 11% vs. 13%; HIV co-infection: 4% vs. 4%. Pts with normal GGT values showed significantly higher early virologic response (EVR) rates at treatment week (TW) 8, as well as higher virologic response rates at TW 12 and at end of treatment (EOT) (table). In line with this observation, pts with normal GGT levels achieved a significantly higher SVR rate together with a significantly lower treatment discontinuation rate (table). Analyzing the association between GGT and EVR in more detail, a marked decline in EVR from 84% in pts with normal GGT to 66% was observed when GGT levels were only slightly elevated to > 1 – 1.5 x ULN while minimal EVR rates of 50% were achieved above GGT levels of 2 x ULN.

Conclusions: Baseline GGT levels within the normal range in approximately 50% of pts with HCV G1 infection are associated with an excellent virologic response to BOC triple therapy resulting in a high SVR rate of 85%. In addition, a high proportion of pts with normal GGT levels achieves an EVR (84%) and may profit from a shortening of treatment duration.

GGT normal

GGT elevated

P

% (n/N)

% (n/N)

HCV-RNA undetectable at TW8 (EVR)

83.6 (102/122)

56.9 (62/109)

< 0.0001

HCV-RNA undetectable at TW12

92.1 (105/114)

81.0 (81/100)

0,0162

HCV-RNA undetectable at EOT

93.2 (110/118)

79.8 (79/99)

0,0033

Sustained virologic response (SVR)

84.8 (84/99)

65.2 (58/89)

0,0017

Treatment discontinuations

18.5 (25/135)

33.6 (42/125)

0,0055