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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
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).
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.