Renal function during treatment with adefovir plus peginterferon alfa-2a vs either drug alone in hepatitis B/D co-infection.

Abstract

Long-term safety of treatment with hepatitis B virus (HBV) polymerase inhibitors is a concern. Adefovir dipivoxil (ADV) therapy has previously been associated with impairment of renal function. Limited data are available on the safety of combination therapy with nucleos(t)ide analogues and interferon alfa (IFNα). The aim of this analysis was to assess the renal function during combination therapy with peginterferon alfa-2a (PegIFNα-2a) plus ADV vs either drug alone in patients with hepatitis B/D co-infection. We performed a retrospective analysis of renal function data of patients treated in the Hep-Net/International Delta Hepatitis Intervention Trial 1(HIDIT-1-trial), a European multicenter study to investigate the efficacy of 48 weeks of therapy with PegIFNα-2a+ADV vs either drug alone in 90 patients with chronic hepatitis B/D co-infection. Glomerular filtration rates (GFR) were calculated by Cockcroft-Gault (CG), abbreviated Modification of Diet in Renal Disease (MDRD) study and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. After 48 weeks of therapy GFR values were significantly lower in patients receiving adefovir-containing treatment vs PegIFNα-2a alone [mean difference 16.1 mL/min (CG) and 10.2 mL/min (MDRD), respectively, P < 0.05] while no differences were observed between patients receiving adefovir alone vs combination treatment. Twenty-four weeks after treatment GFR values did not differ between treatment arms. A decrease in GFR ≥ 20% was observed more often in patients during adefovir-containing treatment vs PegIFNα-2a alone (P < 0.05) which was confirmed by Kaplan-Meier analysis. Adefovir-containing but not PegIFNα-2a treatment was associated with a decrease in GFR values in about one-fifth of patients. Combination treatment of PegIFNα-2a+ADV in chronic hepatitis B/D co-infection did not lead to any further impairment of kidney function.

• Authors: I Mederacke, C Yurdaydin, A Großhennig, A Erhardt, Y Cakaloglu, K Yalcin, S Gurel, S Zeuzem, K Zachou, C Chatzikyrkou, H Bozkaya, G N Dalekos, M P Manns, H Wedemeyer, Hep-Net/International Delta Hepatitis Study Group
• Journal: Journal of viral hepatitis (J Viral Hepat) Vol. 19 Issue 6 Pg. 387-95 (Jun 2012) ISSN: 1365-2893 [Electronic] England
• PMID: 22571900 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2011 Blackwell Publishing Ltd.

Chemical References

• Antiviral Agents
• Interferon-alpha
• Organophosphonates
• Recombinant Proteins
• Polyethylene Glycols
• adefovir
• Adenine
• peginterferon alfa-2a

Topics

• Adenine (administration & dosage, adverse effects, analogs & derivatives)
• Adolescent
• Adult
• Aged
• Aleutian Mink Disease Virus
• Antiviral Agents (administration & dosage, adverse effects)
• Drug Therapy, Combination (adverse effects)
• Female
• Hepatitis B (drug therapy)
• Hepatitis D (drug therapy)
• Humans
• Interferon-alpha (administration & dosage, adverse effects)
• Kidney (drug effects, physiology)
• Male
• Middle Aged
• Organophosphonates (administration & dosage, adverse effects)
• Polyethylene Glycols (administration & dosage, adverse effects)
• Recombinant Proteins (administration & dosage, adverse effects)
• Retrospective Studies
• Young Adult