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Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance.

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Terrault, Norah A., Lok, Anna S.F., McMahon, Brian J., Chang, Kyong‐Mi, Hwang, Jessica P., Jonas, Maureen M., Brown, Robert S., Bzowej, Natalie H. +1 more·2018·Hepatology

Abstract

Potential conflict of interest: Dr. Hwang received grants from Merck and Gilead. Dr. Chang advises Arbutus. Dr. Lok received grants from Gilead and Bristol‐Myers Squibb. Dr. Jonas consults for Gilead and received grants from Bristol‐Myers Squibb and Roche. Dr. Brown consults and received grants from Gilead. Dr. Bzowej received grants from Gilead, Allergan and Cirius. Dr. Terrault received grants from Gilead and Bristol‐Myers Quibb. Dr. Wong is a member of the United States Preventive Services Task Force (USPSTF). This article does not necessarily represent the views and policies of the USPSTF. The funding for the development of this Practice Guidance was provided by the American Association for the Study of Liver Diseases. This practice guidance was approved by the American Association for the Study of Liver Diseases on December 4, 2017. Purpose and Scope of the Guidance This AASLD 2018 Hepatitis B Guidance is intended to complement the AASLD 2016 Practice Guidelines for Treatment of Chronic Hepatitis B1 and update the previous hepatitis B virus (HBV) guidelines from 2009. The 2018 updated guidance on chronic hepatitis B (CHB) includes (1) updates on treatment since the 2016 HBV guidelines (notably the use of tenofovir alafenamide) and guidance on (2) screening, counseling, and prevention; (3) specialized virological and serological tests; (4) monitoring of untreated patients; and (5) treatment of hepatitis B in special populations, including persons with viral coinfections, acute hepatitis B, recipients of immunosuppressive therapy, and transplant recipients. The AASLD 2018 Hepatitis B Guidance provides a data‐supported approach to screening, prevention, diagnosis, and clinical management of patients with hepatitis B. It differs from the published 2016 AASLD guidelines, which conducted systematic reviews and used a multidisciplinary panel of experts to rate the quality (level) of the evidence and the strength of each recommendation using the Grading of Recommendations Assessment, Development and Evaluation system in support of guideline recommendations.1 In contrast, this guidance document was developed by consensus of an expert panel, without formal systematic review or use of the Grading of Recommendations Assessment, Development, and Evaluation system. The 2018 guidance is based upon the following: (1) formal review and analysis of published literature on the topics; (2) World Health Organization guidance on prevention, care, and treatment of CHB5; and (3) the authors’ experience in acute hepatitis B and CHB. Intended for use by health care providers, this guidance identifies preferred approaches to the diagnostic, therapeutic, and preventive aspects of care for patients with CHB. As with clinical practice guidelines, it provides general guidance to optimize the care of the majority of patients and should not replace clinical judgement for a unique patient. This guidance does not seek to dictate a “one size fits all” approach for the management of CHB. Clinical considerations may justify a course of action that differs from this guidance. Interim Data Relevant to the AASLD 2018 Hepatitis B Guidance Since the publication of the 2016 AASLD Hepatitis B Guidelines, tenofovir alafenamide (TAF) has been approved for treatment of CHB in adults. TAF joins the list of preferred HBV therapies, along with entecavir, tenofovir disoproxil fumarate (TDF), and peginterferon (peg‐IFN; Tables 1 and 2)6 (section: Updated Recommendations on the Treatment of Patients With Chronic Hepatitis B). Additionally, studies on the use of TDF for prevention of mother‐to‐child transmission led to TDF being elevated to the level of preferred therapy in this setting (section 1C of Screening, Counseling, and Prevention of Hepatitis B). Table 1 - Approved Antiviral Therapies in Adults and Children Drug Dose in Adultsa Use in Childrena Pregnancy Categoryb Potential Side Effectsb Monitoring on Treatmentc Preferred Peg‐IFN‐α‐2a (adult) IFN‐α‐2b (children) 180 mcg weekly ≥1 year dose: 6 million IU/m2 three times weeklyd C Flu‐like symptoms, fatigue, mood disturbances, cytopenia, autoimmune disorders in adults, anorexia and weight loss in children Complete blood count (monthly to every 3 months) TSH (every 3 months) Clinical monitoring for autoimmune, ischemic, neuropsychiatric, and infectious complications Entecavir 0.5 mg dailye ≥2 years dose: weight‐based to 10‐30 kg; above 30 kg: 0.5 mg dailye C Lactic acidosis (decompensated cirrhosis only) Lactic acid levels if there is clinical concern Test for HIV before treatment initiation Tenofovir dipovoxil fumarate 300 mg daily ≥12 years B Nephropathy, Fanconi syndrome, osteomalacia, lactic acidosis Creatinine clearance at baseline If at risk for renal impairment, creatinine clearance, serum phosphate, urine glucose, and protein at least annually Consider bone density study at baseline and during treatment in patients with history of fracture or risks for osteopenia Lactic acid levels if there is

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  • Therapeutic agents approved by FDA for treatment of chronic HBV infection can achieve sustained suppression of HBV replication and remission of liver disease.

    “Therapeutic agents approved by FDA for treatment of chronic HBV infection can achieve sustained suppression of HBV replication and remission of liver disease (1323).”

    From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [1323]

    The ‘Treatment of Persons With Immune-Active Disease’ section reports sustained off-treatment HBV DNA suppression with peg-IFN, and §6G reports improved liver function with antiviral therapy in patients with decompensated cirrhosis (page numbers unavailable). These passages support viral suppression and liver-disease improvement, but do not establish remission of liver disease as stated. (LLM, conf=0.78)

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  1. [5]World Health Organization Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection 2015 26225396
  2. [7]Brunetto M Lim YS Gane E Seto WK Osipenko M Ahn SH Janssen HS A Phase 3 Study Comparing Tenofovir Alafenamide (TAF) to Tenofovir Disoproxil Fumarate (TDF) in Patients With HBeAg-Negative, Chronic Hepatitis B (CHB): Efficacy and Safety Results at Week 96 Journal of Hepatology 2017 152 suppl 1 S1086
  3. [60]Villa E Rubbiani L Barchi T Ferretti I Grisendi A De Palma M Bellentani S Susceptibility of chronic symptomless HBsAg carriers to ethanol-induced hepatic damage Lancet 1982 2 1243 1244 6128548
  4. [172]Yeo W Chan PK Zhong S Ho WM Steinberg JL Tam JS Hui P Frequency of hepatitis B virus reactivation in cancer patients undergoing cytotoxic chemotherapy: a prospective study of 626 patients with identification of risk factors Journal of Medical Virology 2000 62 299 307 11055239
  5. [254]Teperman L Spivey J Poordad F Schiano T Bzowej N Martin P Coombs D Randomized Trial of Emtricitabine/Tenofovir DF Plus/Minus HBIG Withdrawal in Prevention of Chronic Hepatitis B Recurrence Post-Liver Transplantation: 48 Week Results American Journal of Transplantation 2011 11 suppl 2 48
  6. [256]Coffin CS Stock PG Dove LM Berg CL Nissen NN Curry MP Ragni M Virologic and clinical outcomes of hepatitis B virus infection in HIV-HBV coinfected transplant recipients American journal of transplantation: official journal of the American Society of Transplantation and the American Society of Transplant Surgeons 2010 10 1268 1275 PMC3155863 20346065
  7. [270]Bussler S Vogel M Pietzner D Harms K Buzek T Penke M Handel N New pediatric percentiles of liver enzyme serum levels (ALT, AST, GGT): Effects of age, sex, BMI and pubertal stage Hepatology 2017 e-pub ahead of print 28926121

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Authors
Terrault, N. A., Lok, A. S. F., McMahon, B. J., Chang, K., Hwang, J. P., Jonas, M. M., Brown, R. S., Bzowej, N. H., & Wong, J. B.
Affiliations
  • University of California, San Francisco (US)
  • University of Michigan (US)
  • Alaska Native Tribal Health Consortium (US)
  • Philadelphia VA Medical Center (US)
  • The University of Texas MD Anderson Cancer Center (US)
  • Boston Children's Hospital (US)
  • Weill Cornell Medicine (US)
  • Ochsner Medical Center (US)
  • Tufts University (US)
Corresponding author
Terrault, Norah A.
Venue
Hepatology
Published
2018-03-25
Volume
67
Issue
4
Pages
1560-1599
ISSN
  • 0270-9139 (ISSN-L)
  • 1527-3350
OpenAlex
W2791839818
Cited by
4,306
References
274
Citations by year
2026: 368 · 2025: 503 · 2024: 597 · 2023: 599 · 2022: 589 · 2021: 652 · 2020: 534 · 2019: 328 · 2018: 116 · 2017: 5 · 2015: 1 · 2014: 1
FWCI
318.19
Type
journal article
Language
en
Open access
Locations
  • Hepatology (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • Deep Blue (University of Michigan) (submittedVersion)
Funders
  • Bristol-Myers Squibb
  • American Association for the Study of Liver Diseases
  • Gilead Sciences
  • Allergan
  • National Cancer Institute (P30CA016672)
Topics
  • Health Sciences › Medicine › Epidemiology › Hepatitis B Virus Studies
  • Health Sciences › Medicine › Hepatology › Hepatitis C virus research
  • Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
Keywords
chronic hepatitis B, hepatitis B virus, tenofovir alafenamide, hepatitis B screening, hepatitis B prevention, hepatitis B diagnosis, antiviral therapy, viral coinfection, acute hepatitis B, immunosuppression, transplant recipients, serological tests, clinical management, consensus recommendations
MeSH terms
Adult, Antiviral Agents, Child, Counseling, Humans, Mass Screening, Hepatitis B Vaccines, Hepatitis B, Chronic

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