Z Gastroenterol 2013; 51 - K308
DOI: 10.1055/s-0033-1352958

Treatment of chronic hepatitis C by Pegylated Interferon Alfa-2b (Peg2b) and Ribavirin (RBV): Age-and gender dependent frequency of hematological alterations in a German real-life cohort

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 Mölller 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
  • 2Medical Group Practice, Düsseldorf, Germany
  • 3Medical Group Practice, Herne, Germany
  • 4Gastroenterological Practice, Dortmund, Germany
  • 5Medical High School 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

Aims: Peg2b in combination with RBV has been extensively explored for its efficacy in the treatment of chronic hepatitis C. Its use is accompanied by a variety of hematological side effects which may hamper reaching and maintaining the dose needed for maximal therapeutic effect. Data regarding the frequency of hematological side effects caused by Peg2b/RBV in real-life are still scarce and were therefore evaluated in the present analysis.

Methods: Data from patients (pts) treated for G1 (N = 1873) and G2/3 infection (N = 1323) with Peg2b 1.5 µg/kg/week + weight-based RBV (800 – 1200 mg/day) for up to 48 weeks in a large observational real-life study at 285 sites in Germany were retrospectively analyzed.

Results: The frequencies of grade 1 to 4 declines in Hb, leukocytes, and platelets are summarized in the table. Hb declines grade 1 and 2 were more common in females and pts older than 50yrs. Similarly, females and pts older than 50yrs showed higher frequencies of grade 2 and 3 leukocyte declines. No difference was observed between females and males in declines in platelets, while frequencies of grade 1 to 3 platelet declines were significantly higher in pts older than 50yrs.

Tab. 1: Hematological alterations in pts with G1 infection

Proportion,%

Grade 1 (Mild)

Grade 2
(Moderate)

Grade 3
(Severe)

Grade 4

(Life-threatening)

Hb, g/dL

9.5 – < 11.0

8.0 – < 9.5

6.5 – < 8.0

< 6.5

All

Female/male

Age < 50/> 50yrs

33.5

41.7/27.3 (P < 0.0001)

28.6/43.4 (P < 0.0001)

10.7

15.0/7.3 (P < 0.0001)

8.2/15.7 (P < 0.0001)

0.8

1.1/0.6 (NS)

0.4/1.6 (P = 0.0105)

0.1

0.1/0 (NS)

0/0.2 (NS)

Leukocytes,103/µl

2.0 – < 3.0

1.5 – < 2.0

1.0 – < 1.5

< 1.0

All

Female/male

Age < 50/> 50yrs

42.4

42.3/42.6 (NS)

41.6/44.2 (NS)

13.8

18.0/10.5 (P < 0.0001)

12.2/16.8 (P = 0.0067)

3.5

4.8/2.5 (P = 0.0084)

2.8/5.0 (P = 0.0166)

0.1

0.2/0 (NS)

0.1/0 (NS)

Platelets, 103/µl

70 – <= 100

50 – < 70

25 – < 50

< 25

All

Female/male

Age < 50/> 50yrs

17.0

15.2/18.4 (NS)

15.5/20.0 (P = 0.0128)

5.6

5.5/5.6 (NS)

4.2/8.3 (P = 0.0003)

3.4

3.3/3.5 (NS)

2.3/5.6 (P = 0.0002)

0.6

0.2/0.9 (NS)

0.8/0.3 (NS)

Comparable gender and age dependent difference in hematological alterations were observed in the cohort of G2/3 infected pts. Compared to patients with G1 infection grade 1 and grade 2 declines in Hb (23.0%/5.0%) and leukocytes (38.1%/9.0%) occurred statistically significantly less frequent in G2/3 patients in contrast to similar alterations in platelet count (15.9%/4.6%).

Conclusions: During Peg2b/RBV treatment of chronic HCV infection in real-life Hb and leukocyte declines occur more frequently in G1 infected pts, females and pts older than 50 years. In contrast, alterations in platelet count occur in a similar frequency in pts with G1 and G2/3 infection and depend on age, but not on gender.