title: Granulocyte colony stimulating factor in HCV genotype-1 patients who develop Peg-IFN-alpha2b related severe neutropenia: a preliminary report on treatment, safety and efficacy.
abstract: 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 naïve patients with HCV genotype-1 who received PEG-IFNalpha2b 1.5 mcg/kg/week plus Ribavirin 800-1,400 mg/day and completed the treatment was examined. Nineteen patients who exhibited significant neutropenia and received 150-300 microg G-CSF (Group A) with 19 matched control patients who had dose reductions of Peg-IFNalpha 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 IFNalpha, 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-IFNalpha 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-alpha2b related severe neutropenia.
authors.affiliation: 2nd Department of Internal Medicine, Medical School of Athens, Hippokration Hospital of Athens, Athens, Greece. koskinas@ath.forthnet.gr
authors.forename: John
authors.initials: J
authors.lastname: Koskinas
authors.forename: George
authors.initials: G
authors.lastname: Zacharakis
authors.forename: John
authors.initials: J
authors.lastname: Sidiropoulos
authors.forename: John
authors.initials: J
authors.lastname: Elefsiniotis
authors.forename: Savvas
authors.initials: S
authors.lastname: Savvas
authors.forename: Stamatia
authors.initials: S
authors.lastname: Kotsiou
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Kountouras
authors.forename: Maria
authors.initials: M
authors.lastname: Schina
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Kostopoulos
authors.forename: Athanasios
authors.initials: A
authors.lastname: Archimandritis