Document Detail

Renal tubular dysfunction during long-term adefovir or tenofovir therapy in chronic hepatitis B.
MedLine Citation:
PMID:  22506503     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Adefovir and tenofovir are nucleotide analogues used as long-term therapy of chronic hepatitis B. Side effects are few, but prolonged and high-dose therapy has been associated with proximal renal tubular dysfunction (RTD).
AIM: To assess the incidence of RTD during long-term nucleotide therapy of chronic hepatitis B.
METHODS: A total of 51 patients being treated at the Clinical Center, National Institutes of Health were studied. Diagnosis of RTD required de novo appearance of at least three of five features: hypophosphataemia, hypouricaemia, serum creatinine elevation, proteinuria or glucosuria.
RESULTS: Among 51 patients treated for 1-10 (mean 7.4) years with adefovir (n = 42), tenofovir (n = 4) or adefovir followed by tenofovir (n = 5), 7 (14%) developed RTD. Time to onset ranged from 22 to 94 (mean 49) months with an estimated 10-year cumulative rate of 15%. All seven had low urinary percent maximal tubular reabsorption of phosphate (<82%). Patients with RTD were older (58 vs. 44 years; P = 0.01) and had lower baseline glomerular filtration rates (82 vs. 97 cc/min; P = 0.08) compared to those without; but did not differ in other features. Six patients with RTD were switched to entecavir, all subsequently had improvements in serum phosphate (2.0-3.0 mg/dL), creatinine (1.6-1.1 mg/dL), uric acid (2.7-3.8 mg/dL) and proteinuria.
CONCLUSIONS: Renal tubular dysfunction develops in 15% of patients treated with adefovir or tenofovir for 2-9 years and is partially reversible with change to other antivirals. Monitoring for serum phosphate, creatinine and urinalysis is prudent during long-term adefovir and tenofovir therapy.
N Gara; X Zhao; M T Collins; W H Chong; D E Kleiner; T Jake Liang; M G Ghany; J H Hoofnagle
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Intramural     Date:  2012-04-16
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  35     ISSN:  1365-2036     ISO Abbreviation:  Aliment. Pharmacol. Ther.     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-05-02     Completed Date:  2012-08-16     Revised Date:  2013-06-26    
Medline Journal Info:
Nlm Unique ID:  8707234     Medline TA:  Aliment Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  1317-25     Citation Subset:  IM    
Copyright Information:
Published 2012. This article is a US Government work and is in the public domain in the USA.
Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.
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MeSH Terms
Adenine / adverse effects,  analogs & derivatives*
Antiviral Agents / adverse effects*
Biological Markers / metabolism
Creatinine / metabolism
Glomerular Filtration Rate / drug effects*
Hepatitis B, Chronic / drug therapy*
Kidney Tubules / drug effects
Middle Aged
Organophosphonates / adverse effects*
Phosphates / metabolism
Renal Insufficiency / chemically induced*
Time Factors
Uric Acid / metabolism
Grant Support
Reg. No./Substance:
0/Antiviral Agents; 0/Biological Markers; 0/Organophosphonates; 0/Phosphates; 107021-12-5/tenofovir; 60-27-5/Creatinine; 69-93-2/Uric Acid; 6GQP90I798/adefovir; 73-24-5/Adenine
Comment In:
Aliment Pharmacol Ther. 2012 Nov;36(10):992-3; author reply 993   [PMID:  23072605 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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