2013 NICE CG165 儿童、青少年、成人慢性乙型肝炎的诊断和管理
Diagnosis and management of chronic hepatitis B in children, young people and adults
2013-06-21
This guideline updates and replaces recommendations in NICE technology appraisal 96 andincorporates recommendations from NICE technology appraisals 96, 153, 154 and 173. SeeAbout this guideline for details.Chronic hepatitis B describes a spectrum of disease usually characterised by the presence ofdetectable hepatitis B surface antigen (HBsAg) in the blood or serum for longer than 6 months. Insome people, chronic hepatitis B is inactive and does not present significant health problems, butothers may progress to liver fibrosis, cirrhosis and hepatocellular carcinoma (HCC). Theprogression of liver disease is associated with hepatitis B virus (HBV) DNA levels in the blood.Without antiviral treatment, the 5-year cumulative incidence of cirrhosis ranges from 8 to 20%.People with cirrhosis face a significant risk of decompensated liver disease if they remainuntreated. Five-year survival rates among people with untreated decompensated cirrhosis canbe as low as 15%. Chronic hepatitis B can be divided into e antigen- (HBeAg) positive or HBeAgnegativedisease based on the presence or absence of e antigen. The presence of HBeAg istypically associated with higher rates of viral replication and therefore increased infectivity.The goal of treatment for chronic hepatitis B is to prevent cirrhosis, HCC and liver failure. Inclinical practice surrogate markers are used to monitor progression of disease and treatmentresponse, and include normalisation of serum alanine aminotransferase (ALT) levels, decreasein inflammation scores with no worsening or improvement in fibrosis on liver biopsies,suppression of serum HBV DNA to undetectable levels, loss of HBeAg and seroconversion toHBe antibody (anti-HBe), and loss of HBsAg and seroconversion to HBs antibody (anti-HBs).Antiviral therapy suppresses HBV replication and decreases hepatic inflammation and fibrosis,thereby reducing the likelihood of serious clinical disease. Since the introduction of effectivetreatment in the form of interferon alfa, several nucleoside and nucleotide analogues are nowapproved for use in adults with chronic hepatitis B, together with a pegylated form of interferonalfa. With multiple treatment options that are efficacious and safe, the key questions are whichpatients need immediate treatment and what sequence and combination of drug regimensshould be used, and which patients can be monitored and delay treatment.In this guideline we cover the following:information needs of people with chronic hepatitis B and their carerswhere children, young people and adults with chronic hepatitis B should be assessedassessment of liver disease, including the use of non-invasive tests and genotype testingcriteria for offering antiviral treatmentthe efficacy, safety and cost effectiveness of currently available treatmentsselection of first-line therapymanagement of treatment failure or drug resistancewhether there is a role for combination therapywhen it is possible to stop treatmentmanaging the care of pregnant and breastfeeding women and prevention of verticaltransmissionprophylactic treatment during immunosuppressive therapymonitoring for treatment response, severity of fibrosis and development of HCC.
