Recommendation ID
CG165/3
Question
Long-term safety of tenofovir disoproxil in chronic hepatitis B:- Further research should be undertaken to determine the long-term safety of tenofovir disoproxil, including the risk of clinically significant hypophosphataemia and related bone toxicity, in people with chronic hepatitis B. The cost effectiveness of routine monitoring for phosphate loss and bone disease in people with chronic hepatitis B who are receiving tenofovir disoproxil treatment needs further evaluation.
Any explanatory notes
(if applicable)
Why this is important:- Tenofovir disoproxil is recommended as an option for treatment of people with chronic hepatitis B, and is typically prescribed for long-term use. Kidney dysfunction has been reported in people treated with tenofovir disoproxil, including rare cases of proximal renal tubular dysfunction that appear related to long-term exposure but are not well understood. Adverse renal effects such as hypophosphataemia may have an impact on bone architecture which could result in clinical problems such as fragility fractures. Monitoring for phosphate loss and bone disease could have a role in preventing clinically significant bone problems in people with chronic hepatitis B receiving long-term tenofovir disoproxil. However, the cost effectiveness and clinical utility of routine monitoring needs to be established before recommendations can be made about its use.

Source guidance details

Comes from guidance
Hepatitis B (chronic): diagnosis and management
Number
CG165
Date issued
June 2013

Other details

Is this a recommendation for the use of a technology only in the context of research? No  
Is it a recommendation that suggests collection of data or the establishment of a register?   No  
Last Reviewed 12/07/2013