title: Safety and efficacy of an escalating dose regimen of pegylated interferon alpha-2b in the treatment of haemodialysis patients with chronic hepatitis C.
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.
authors.affiliation: Selayang Hospital, Batu Caves, Selangor, Malaysia. tanss@selayanghospital.gov.my
authors.forename: S S
authors.initials: SS
authors.lastname: Tan
authors.forename: M R
authors.initials: MR
authors.lastname: Abu Hassan
authors.forename: A
authors.initials: A
authors.lastname: Abdullah
authors.forename: B P
authors.initials: BP
authors.lastname: Ooi
authors.forename: T
authors.initials: T
authors.lastname: Korompis
authors.forename: M I
authors.initials: MI
authors.lastname: Merican
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects*; D011994:Recombinant Proteins; D006435:Renal Dialysis / Q000009:adverse effects; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b