title: Granulocyte colony-stimulating factor for hepatitis C therapy-associated neutropenia: systematic review and economic evaluation.
abstract: Hepatitis C virus (HCV) treatment requires maximal adherence to pegylated interferon (Peg-IFN) and ribavirin to achieve a sustained virologic response (SVR). Neutropenia is the most common cause for Peg-IFN dose reduction. Our objectives were to evaluate the effectiveness, safety and cost-effectiveness of granulocyte colony-stimulating factor (G-CSF) versus Peg-IFN dose reduction for HCV therapy-associated neutropenia in treatment naïve adults. We conducted a systematic review to identify controlled trials and observational studies. Study selection, quality assessment and data extraction were completed independently by two investigators. Cost-effectiveness and cost-utility analyses compared G-CSF with dose reduction. Nineteen studies were included. In one trial, the SVR for those receiving G-CSF was 54.5% (95% CI: 34.7-73.1) compared with 26.3% (95% CI: 11.8-48.8) for dose reduction. The remaining studies were case series or retrospective cohorts and provided weak evidence for the relationship between SVR and G-CSF. The risk of adverse events, including infection, associated with G-CSF was low (13.1%; 95% CI: 8.0-20.8) and clinically insignificant. G-CSF had an incremental cost-effectiveness ratio of $41,701 per SVR achieved in genotype 1, and $16,115 per SVR achieved in genotype 2 or 3. Estimates were robust under a variety of resource and intervention scenarios. While administration of G-CSF may enable patients to remain on or resume optimal HCV therapy, there was weak evidence that this improves the likelihood of SVR compared with dose reduction. Adverse effects of G-CSF are mild. The economic evaluation was inconclusive.
authors.affiliation: Division of Gastroenterology, University of Alberta Evidence-based Practice Center, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: P
authors.initials: P
authors.lastname: Tandon
authors.forename: K
authors.initials: K
authors.lastname: Doucette
authors.forename: K
authors.initials: K
authors.lastname: Fassbender
authors.forename: B
authors.initials: B
authors.lastname: Vandermeer
authors.forename: T
authors.initials: T
authors.lastname: Durec
authors.forename: D M
authors.initials: DM
authors.lastname: Dryden
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination; D016179:Granulocyte Colony-Stimulating Factor / Q000191:economics* / Q000627:therapeutic use*; D016174:Hepacivirus / Q000187:drug effects; D006526:Hepatitis C / Q000188:drug therapy; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use; D009503:Neutropenia / Q000139:chemically induced / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a