Hepatitis B (chronic): diagnosis and management

Evidence

We found 58 studies in a search for randomised controlled trials and systematic reviews published between 10 October 2012 and 9 March 2017. We also included 1 relevant study identified by members of the guideline committee who originally worked on this guideline.

From all sources, we considered 59 studies to be relevant to the guideline.

We also checked for relevant ongoing research, which will be evaluated again at the next surveillance review of the guideline.

See appendix A: summary of evidence from surveillance for details of all evidence considered, and references.

Views of topic experts

We considered the views of topic experts, including those who helped to develop the guideline.

Views of stakeholders

Stakeholders commented on the decision not to update the guideline. Overall, 7 stakeholders commented. See appendix B for stakeholders' comments and our responses. Six stakeholders commented on the proposal to not update the guideline with 3 agreeing and 3 disagreeing with the decision.

Two stakeholders referred to a recently published recommendation by the European Association for the Study of the Liver (EASL) as a reason to update the guideline. The EASL guideline recommends: 'patients with HBeAg-positive chronic HBV infection, defined by persistently normal ALT and high HBV DNA levels, may be treated if they are older than 30 years regardless of the severity of liver histological lesions'. This contradicts the current recommendation in NICE's guideline on diagnosis and management of hepatitis B, which states that persistently elevated ALT serum levels (greater than or equal to 30 IU/litre in males and greater than or equal to 19 IU/litre in females) on 2 consecutive tests conducted 3 months apart are an indication for treatment. The EASL recommendation was, by its own grading criteria, a weaker recommendation with less certainty based on the opinions of respected authorities and descriptive epidemiology whereas the NICE recommendation was determined from a full systematic review of all the relevant published evidence. As the difference between the EASL recommendation and the NICE guideline is not driven by new evidence, no impact on NICE's guideline on hepatitis is anticipated at this time.

Comments received by several stakeholders were about testing for hepatitis B and as such were outside the scope for this guideline. Recommendations on testing can be found in NICE's guideline on hepatitis B and C testing in people at risk of infection.

Several stakeholders highlighted published studies or feedback from clinical practice as part of their challenge to the proposal to remove 3 prioritised research recommendations from the NICE guideline and the NICE research recommendations database (research recommendation 1 in particular) with the majority stating that they are ongoing questions which should be retained. Upon review of this and previous evidence, we propose to retain all 4 of the current research recommendations.

See ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual for more details on our consultation processes.

NICE Surveillance programme project team

Kay Nolan
Associate Director

Martin Allaby
Consultant Clinical Adviser

Emma McFarlane
Technical Adviser

Stephen Robinson
Technical Analyst

The NICE project team would like to thank the topic experts who participated in the surveillance process.

ISBN: 978-1-4731-2705-0