Z Gastroenterol 2013; 51 - K310
DOI: 10.1055/s-0033-1352960

Changes of demographic- and disease characteristics of patients with chronic HCV genotype 1 infection In Germany during the past decade

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, T Dahhan 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
  • 5Medical Department II, Klinikum Burghausen, Burghausen, Germany
  • 6Center of Gastroenterology and Liver Center, Berlin, Germany
  • 7Gastroentorological Practice, Fulda, Germany
  • 8Medical Practice, Kassel, Germany
  • 9Gastroenterological Practice, Stade, Germany
  • 10Friedrich-Schiller-University, Jena, Germany
  • 11Gastroenterological Practice, Nürnberg, Germany
  • 12Center of Medicine, Berlin, Germany
  • 13Gastroenterological Practice, Fellbach, Germany
  • 14MSD Pharma GmbH, Haar, Germany

Aims: In 2011, first generation HCV protease inhibitors combined with PegIFN and ribavirin (RBV) have been introduced as new standard of care for patients with chronic hepatitis C genotype 1 (G1) infection. We analyzed possible changes of demographic and disease characteristics of the German HCV-G1 population during the past decade which could influence the efficacy of novel HCV therapies in real-life.

Methods: Data from 2226 G1-infected pts included in the German PegIFN2b/RBV observational study (Online-AWB) from 09/2003 to 05/2007 at 285 sites were retrospectively analyzed and compared with data from the ongoing Victrelis® (boceprevir) observational study (NOVUS, started in May 2012). Until March 2013 data from 193 of 307 pts treated with PegIFN/RBV/boceprevir at 85 sites were documented and included in the present analysis.

Results: G1-infected pts included in the recent and ongoing NOVUS study are older, have a higher weight and BMI, more frequently have a high baseline viral load and are more frequently coinfected with HIV. Further, there is a significant higher proportion of drug users under substitution and a 3-fold higher proportion of pretreated pts. There was no difference in the frequency of liver cirrhosis or platelet counts < 150/nL, an indirect indicator of advanced fibrosis/cirrhosis (Table).

Tab. 1

Online AWB

N = 2226

NOVUS

N = 193

P

Females

41.9

37.8

0.2544

Age-yrs

Age > 50yrs

43.8 ± 12.4

29.3

47.8 ± 12.2

46.6

< 0.0001

< 0.0001

BMI-kg/m2

25.3 ± 4.3

26.4 ± 5.3

0.0073

Viral load

> 800.000 IU/ml*

39.9

53.4

0.0003

Liver cirrhosis

Platelets < 150/nL*

Hb-g/dl*

7.4

15.9

14.7 ± 1.5

4.7

16.1

14.5 ± 1.5

0.1619

0.9407

0.0950

Co-infection

HIV

HBV

1.8

2.2

5.7

2.1

0.0017

1.0000

Drug user under substitution

9.6

14.5

0.0280

Pretreated pts

12.0

32.6

< 0.0001

Mean ± SD or %

*at Baseline

Conclusions: During the past decade the German population infected with HCV G1 progressed in age, BMI and baseline viral load, known factors associated with less response to PegIFN/RBV treatment. Further, this population consists of a higher proportion of pretreated pts and drug users under substitution. Overall, there is a considerable increase in the number of “difficult-to-treat” pts currently treated with novel protease inhibitor regimens in real-life.