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G-CSF is safe and improves adherence and SVR in HCV patients with genotype 1 who develop Peg-IFNa-2b related severe neutropenia
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G. Zacharakis1; J. Koskinas1; J. Sidiropoulos2; J. Elefsiniotis4; S. Savvas1; D. Kountouras1; M. Schina1; P. Kostopoulos3; A. Archimandritis1
1. 2nd Departement of Internal Medicine, University of Athens, Athens, Greece.
2. Academic Department of Medicine A, Aristoteleion University of Thrace,
Thessaloniki, Greece.
3. Department of Gastroenterology, 251General Hospital of Hellenic Air Force, Athens, Greece.
4. Departmentof Medicine, Hippokration General Hospital, Athens, Greece.
Background: Peg-IFN treatment in patients with chronic HCV infection induces neutropenia with subsequent dose reductions that may reduce the SVR. Granulocyte colony-stimulating factor (G-CSF) has been used by some physicians instead of the standard dose reduction practice. However, additional studies are required before these agents can be recommended for routine use.
Aim: To evaluate the safety and benefits of G-CSF compared to standard practice of dose reduction in patients with peg-IFN induced neutropenia.
Methods: Open-label study of 39 treated-naïve patients of 249 (16%) with chronic hepatitis C genotype-1 infection who were on treatment with PEG-INFa-2b 1.5mcg/kg/week and RBV 800-1400mg/day weight based and developed significant neutropenia (ANC<1000/L). They received either a flexible scheme of 150-300ug G-CSF SC twice a week (one day after and two days before Peg-IFN injection), (Group A, 20 pts) or had escalating dose reduction of Peg-IFN for 2wks or discontinuation for 1-2 wks in unresolved cases (Group B, 19 pts). HCV-RNA was measured by Cobas Amplicor (Roche).
Results: Both groups had no significant differences before treatment regarding age (53±9 years vs 47±7), sex (55% males vs 50%), HCV-RNA levels (2.76±1.9 million IU/ml vs 2.23±2.1), Hb levels (13.5±2.3 mg/dl vs 14±1.7) and WBC (6000/mm3 vs 5800), respectively. The mean decline of the neutrophils was 1760±1030/mm3 at 11±8.6 wks and 1630±890 at 12.3±6.1 in group A and B respectively. Patients who received G-CSF maintained neutrophil count between 1420-2720/mm3 and remained on G-CSF support for 29 wks (2-40). In this group, 12/20(60%) had EVR and 6/20 (30%) SVR. In group B, Peg-IFN was temporarily withdrawn in 3/19 and reduced to 0.5mcg/kg/wk in 4/19 patients. The neutrophil count ranged between 1320-3400/mm3. In this group, 9/19 (47%) had EVR and 4/19 (21%) SVR (significant lower compared to group A, p<0.001). All patients completed 48wks of treatment with no major side effects or infection. No related to G-CSF side effects were encountered.
Conclusions: The use of G-CSF 1) is safe and allows adherence to treatment schedule in patients with chronic HCV-1 infection who develop neutropenia during treatment, and, 2) relates to higher EVR and SVR and therefore it should be considered in clinical practice
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