Safety and efficacy of an escalating dose regimen of pegylated interferon alpha-2b in the treatment of haemodialysis patients with chronic hepatitis C

J Viral Hepat. 2010 Jun;17(6):410-8. doi: 10.1111/j.1365-2893.2009.01191.x. Epub 2009 Sep 15.

Abstract

Chronic hepatitis C is associated with increased morbidity and mortality in persons undergoing haemodialysis. This single-arm, open-label clinical trial investigated the safety and efficacy of an escalating dosage regimen of pegylated interferon (PEG-IFN) alpha-2b in this patient population. Patients with chronic hepatitis C who were undergoing haemodialysis began treatment with PEG-IFN alpha-2b at a dose of 0.5 microg/kg/week, which was increased every 4 weeks to a maximum of 1 microg/kg/week. Treatment duration was 24 weeks for patients with genotype (G) 2 or 3 infection and 48 weeks for patients with G1 infection. The primary end point was sustained virological response (SVR). Of 46 patients screened, 34 (G1: 70.6%; G3: 29.4%) were treated and 23 (67.6%) completed treatment. Overall, 85.3% of patients experienced early virological response, 52.9% experienced end-of-treatment response, and 50% attained SVR, with a trend toward higher SVR rates in G3 compared with G1 patients (80%vs 37.5%; P = 0.06). Anaemia was the main reason for discontinuation of treatment. Patients with chronic hepatitis C who are undergoing haemodialysis can be successfully treated with an escalating dosage regimen of PEG-IFN alpha-2b monotherapy. G3-infected patients can attain high rates of SVR with only 24 weeks of therapy.

Publication types

  • Clinical Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anemia / chemically induced
  • Antiviral Agents / administration & dosage*
  • Antiviral Agents / adverse effects*
  • Female
  • Genotype
  • Hepacivirus / classification
  • Hepacivirus / genetics
  • Hepacivirus / isolation & purification
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / administration & dosage*
  • Interferon-alpha / adverse effects*
  • Male
  • Middle Aged
  • Polyethylene Glycols / administration & dosage*
  • Polyethylene Glycols / adverse effects*
  • Recombinant Proteins
  • Renal Dialysis / adverse effects
  • Treatment Outcome
  • Viral Load
  • Young Adult

Substances

  • Antiviral Agents
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Polyethylene Glycols
  • peginterferon alfa-2b