1. adefovir dipivoxil and peginterferon alfa-2a for the treatment of chronic hepatitis B (TA96)

2. entecavir for the treatment of chronic hepatitis B (TA153)

3. telbivudine for the treatment of chronic hepatitis B (TA154).

As you may be aware the planned date for review of the above guidance is February 2009.

This is the date at which the Institute decides whether sufficient new evidence has emerged for the Appraisal Committee to undertake an appraisal to update the existing guidance.

The Institute has carried out a search for information relevant to this appraisal, and has found that to the best of its knowledge, no new evidence has been published that would have a material effect on the original guidance.  However, we are aware of clinical trials assessing the efficacy of combination therapy versus monotherapy, in addition to including Hepatitis B – tenofovir disproxil fumarate. Consequently we propose that we consider again, whether or not to update these guidance’s in March 2010. This will allow the research to be available to inform the decision on whether or not an update is required.

In order to be completely confident that this is appropriate, we are asking consultees and commentators with an interest in this topic, to inform us of any evidence which would suggest that an earlier review would be beneficial. We would particularly like to be made aware of timelines around on-going research, etc. which might affect the scheduling of this review should we go ahead with the proposal following this consultation. 

Please note all comments received will be published on the Institute’s website when a decision has been made.

• A full list of the organisations contacted for this review

May 2009