Subscribe to RSS
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
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.
Proportion,% |
||||
Grade 1 (Mild) |
Grade 2 |
Grade 3 |
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.