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

• Published in: Journal of viral hepatitis 2010-06, Vol.17 (6), p.410-418
• Main Authors: Tan, S. S., Abu Hassan, M. R., Abdullah, A., Ooi, B. P., Korompis, T., Merican, M. I.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Anemia - chemically induced; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; chronic hepatitis C; escalating dose regimen; Female; Genotype; haemodialysis; Hepacivirus - classification; Hepacivirus - genetics; Hepacivirus - isolation & purification; Hepatitis C, Chronic - drug therapy; Humans; Interferon-alpha - administration & dosage; Interferon-alpha - adverse effects; kidney; Male; Middle Aged; pegylated interferon alpha-2b; Polyethylene Glycols - administration & dosage; Polyethylene Glycols - adverse effects; Recombinant Proteins; Renal Dialysis - adverse effects; renal dysfunction; Treatment Outcome; Viral Load; Young Adult
• ISSN: 1352-0504; 1365-2893
• DOI: 10.1111/j.1365-2893.2009.01191.x

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 μg/kg/week, which was increased every 4 weeks to a maximum of 1 μg/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.