Z Gastroenterol 2013; 51 - K302
DOI: 10.1055/s-0033-1352952

Leukocytes decline > 2500/µl during Peginterferon Alfa-2B (PEG-2B)/Ribavirin (RBV) treatment predicts favorable SVR rates in difficult-to-treat patients with HCV Genotype 1 (G1) infection in real-life

G Teuber 1, S Mauss 2, D Hüppe 3, E Zehnter 4, MP Manns 5, T Dahhan 6, U Meyer 7, T Witthöft 8, B Möller 7, N Dikopoulos 9, J Brack 10, D Hartmann 11, B Dreher 11 M Bilzer 11, bng hepatitis study group, Neu-Ulm, Germany
  • 1Gastroenterological Practice, Frankfurt, Germany
  • 2Center for HIV and Hepatogastroenterology, Düsseldorf, Germany
  • 3Medical Group Practice, Herne, Germany
  • 4Gastroenterological Practice, Dortmund, Germany
  • 5Medical School of Hannover, Hannover, Germany
  • 6Medical Practice, Fellbach, Germany
  • 7Medical Practice, Berlin, Germany
  • 8Gastroenterological Practice, Stade, Germany
  • 9Gesundheitszentrum Langenau, Langenau, Germany
  • 10Hospital Nord Ochsenzoll, Hamburg, Germany
  • 11MSD Pharma GmbH, Haar, Germany

Background and aims: Leukocyte decline during antiviral treatment of chronic HCV infection may reflect pharmacodynamic effects of pegylated interferons. We therefore investigated the possible association between leukocyte decline and SVR in difficult-to-treat patients (pts) undergoing Peg2b/RBV therapy for HCV G1 infection in real-life.

Methods: Data from the German Peg2b/RBV observational study were retrospectively analyzed. This real-life cohort study assessed the safety and efficacy of treatment of G1 infection with Peg2b 1.5 µg/kg/week + weight-based RBV (800 – 1200 mg/day) for up to 48 weeks at 285 sites. SVR was defined as undetectable serum HCV-RNA 24 weeks after end of treatment.

Results: 1.890 pts with G1 infection (44.1 ± 12.3yrs, female 43%, BMI 25.3 ± 4.7, baseline viral load of ≥600,000 IU/ml in 52.2%) had baseline and at least one leukocyte measurement during therapy. Overall, SVR following Peg2b/RBV treatment was 42.3%. A significant difference in SVR rates was observed between pts with maximal leukocyte decline > 2.500/µL (45.6%) and pts with leukocytes declines ≤2.500/µL (32.7%, Table). Higher SVR rates in pts with leukocyte declines > 2.500/µL were significantly (p = 0.0067) associated with lower non-response rates of 32.0% (458/1430) compared to 39.1% (164/419) in pts with a leukocyte decline ≤2.500/µL, while relapse rates did not differ (22.5% vs. 23.0%, p = 0.87). Leukocyte declines > 2.500µL were significantly associated with higher SVR rates in difficult-to-treat pts, such as pts ≥50yrs or pts with high baseline viral load.

Tab. 1

Maximal leukocyte decline

SVR,% (n/N)

≤2500/µl

> 2500/µl

P

Overall

32.7 (137/419)

45.6 (652/1430)

< 0.0001

Female

36.7 (72/196)

51.1 (309/605)

0.0005

Male

29.1 (65/223)

41.6 (343/825)

0.0007

Age < 50 years

35.8 (88/246)

48.9 (480/982)

0.0002

Age ≥50 years

28.3 (49/173)

38.4 (172/448)

0.0188

LVL < 600.000 IU/ml

38.8 (73/188)

55.9 (356/637)

< 0.0001

HVL ≥600.000 IU/ml

26.4 (57/216)

37.3 (279/747)

0.0029

Conclusions: A leukocyte decline > 2.500/µL predicts favorable SVR rates in difficult-to-treat patients undergoing Peg2b/RBV treatment for chronic HCV G1 infection in real-life. In general, leukocyte decline as pharmacodynamic Peg2b effect seems to reflect its antiviral activity.