Session Title: Category 5g. VIRAL HEPATITIS: g. HEPATITIS C - CLINICAL (THERAPY)
Presentation Date: Apr 15, 2010
TREATMENT-INDUCED ANEMIA PREDICTS SVR AMONG ALL HCV-GENOTYPES TREATED WITH PEG-IFN α-2B AND RIBAVIRIN: MARKED DIFFERENCES BETWEEN FEMALE AND MALE
G. Teuber1*, S. Mauss2, E. Zehnter3, M.P. Manns4, T. Dahhan5, S. Kaiser6, U. Meyer7, T. Witthöft8, B. Möller9, N. Dikopoulos10, J. Brack11, M. Bilzer12, G. Tossing12, D. Hüppe13, BNG Hepatitis Study Group
1Johann Wolfgang Goethe-University, Frankfurt, 2Medical Group Practice, Düsseldorf, 3Gastroenterological Practice, Dortmund, 4Medical High School Hannover, Hannover, 5Medical Practice, Backnang, 6University of Tübingen, Tübingen, 7Medical Practice, Berlin, 8University of Lübeck, Lübeck, 9Leberzentrum, Medical Practice, Berlin, 10University of Ulm, Ulm, 11Hospital Nord Ochsenzoll, Hamburg, 12Essex Pharma GmbH, München, 13Medical Group Practice, Herne, Germany. *email@example.com
Background and aims: Recently, it has been shown by the IDEAL study that treatment-related anemia predicts high SVR rates in genotype 1 (G1) patients treated with PEG-IFNα-2+ribavirin (NEJM 2009; 361: 580). In order to test the relevance of these findings for the outcome of G1 and other genotypes in the real-life setting, we retrospectively analysed data from the German Peg-IFNα-2b/ribavirin observational study.
Methods: This real-life cohort study assessed the safety and efficacy of PegIFNα-2b 1.5 µg/kg/wk+weight-based ribavirin (800-1200 mg/d) for 24 weeks in G2/3 patients and for up to 48 weeks in G1 pts at 285 sites. SVR was defined as undetectable serum HCV-RNA 24 weeks after EOT response. Anemia was defined as Hb< 10 g/dL. Viral response rates were assessed in 5 groups:
1) All patients;
2) No anemia;
4) Early anemia (≤8 wks);
5) Late anemia (>8 wks).
Results: 2722 patiens were available for evaluation. Compared to those with no anemia, anemic female patients with G1, G2 and G3 infections were more likely to achieve SVR. In contrast, anemic male patients showed a trend towards lower SVR rates among all genotypes. The highest SVR rates were achieved by patients with late anemia compared to early anemia. Again, marked differences in SVR rates by more than 20% were obtained by the comparison of male and female patients.
Conclusions: The present analysis demonstrates an association between treatment-related anemia and SVR among all genotypes. SVR rates predicted by anemia differ between female and male patients suggesting an important role for gender-dependent mechanisms influencing patient outcome.
| ||G1 ||G2 ||G3 |
| ||Female ||Male ||Female ||Male ||Female ||Male |
|All ||49.2% (336/683) ||41.4%a (362/875) ||75.6% (65/86) ||78.5% (102/130) ||70.8% (228/322) ||67.7% (424/626) |
|No Anemia ||46.4% (224/483) ||42.0% (314/748) ||71.9% (46/64) ||79.3% (92/116) ||69.4% (184/265) ||68.1% (401/589) |
|Anemia ||56.0% (112/200) [p=0.0221] ||37.8%b (48/127) [p=0.37] ||90.5% (19/21) ||71.4% (10/14) ||77.2% (44/57) ||62.2% (23/37) |
|Early Anemia ||43.3% (39/90) ||28.0% (14/50) ||84.6% (11/13) ||50.0% (3/6) ||68.8% (22/32) ||46.2% (6/13) |
|Late Anemia ||66.4% (73/110) [p=0.0011] ||44.2%c (34/77) [p=0.067] ||100% (8/8) ||87.5% (7/8) ||88.0% (22/25) ||70.8% (17/27) |
χ2-test of anemic groups vs no anemia and late vs early anemia.
ap=0.0021; bp=0.0013; cp=0.0025; χ2-test of female vs male pts