Granulocyte Colony Stimulating Factor in HCV Genotype-1 Patients Who Develop Peg-IFN-α2b Related Severe Neutropenia: A Preliminary Report on Treatment, Safety and Efficacy

Dose reductions of Peg-IFNa because of severe neutropenia may affect the virologic response in patients with hepatitis C infection (HCV). Granulocyte colony-stimulating factor (G-CSF) has been used occasionally but studies addressing its safety and efficacy in the current treatment of HCV infection are missing. The database of 232 naive patients with HCV genotype-1 who received PEG-IFN alpha 2b 1.5 mcg/kg/week plus Ribavirin 8001,400 mg/day and completed the treatment was examined. Nineteen patients who exhibited significant neutropenia and received 150-300 mu g GCSF (Group A) with 19 matched control patients who had dose reductions of Peg-IFN alpha according to the standard recommendations (Group B) were examined. None of the patients had treatment modifications due to thrombocytopenia or anemia. The mean decline of the neutrophils was similar in groups A and B (1,760 +/- 1,030/mm(3) at 11 +/- 8.6 weeks and 1,630 +/- 890 at 12.3 +/- 6.1, respectively). Nadir neutrophil values were also not statistically different. Patients who received G-CSF two before IFN alpha, maintained neutrophils between 1,400/mm(3) and 2,700/mm(3) and remained on G-CSF for 29 weeks (2-40). Virologic response at the end of treatment was observed in 12/19 (63%) patients and at 6 months follow-up in 6/19(32%) in group A as compared to 9/19 (47%) and 4/19 (21%) in group B, respectively. No side effects related to G-CSF were encountered. Administration of G-CSF 2 days before Peg-IFNa is safe, maintains sustained neutrophil count, improves adherence to treatment and seems to increase the virologic response in patients infected with HCV genotype 1 who develop Peg-IFN-alpha 2b related severe neutropenia. J. Med. Virol. 81:848-852, 2009. (C) 2009 Wiley-Liss, Inc.