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Update on Prevention, Diagnosis, and Treatment of Chronic Hepatitis B: AASLD 2018 Hepatitis B Guidance

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Update on Prevention, Diagnosis, and Treatment of Chronic Hepatitis B: AASLD 2018 Hepatitis B Guidance AMERICAN ASSOCIATION FOR THE STUDY OFLIVERD I S E ASES PRACTICE GUIDANCE | HEPATOLOGY, VOL. 67, NO. 4, 2018 Update on Prevention, Diagnosis, and Treatment of Chronic Hepatitis B: AASLD 2018 Hepatitis B Guidance Norah A. Terrault,1 Anna S.F. Lok,2 Brian J. McMahon,3 Kyong-Mi Chang,4 Jessica P. Hwang,5 Maureen M. Jonas,6 Robert S. Brown Jr.,7 Natalie H. Bzowej,8 and John B. Wong9 hepatitis B. It differs from the published 2016 Purpose and Scope of the AASLD guidelines, which conducted systematic Guidance reviews and used a multidisciplinary panel of experts to rate the quality (level) of the evidence and the strength This AASLD 2018 Hepatitis B Guidance is of each recommendation using the Grading of Recom- intended to complement the AASLD 2016 Practice mendations Assessment, Development and Evaluation Guidelines for Treatment of Chronic Hepatitis B(1) system in support of guideline recommendations.(1-4) and update the previous hepatitis B virus (HBV) In contrast, this guidance document was developed by guidelines from 2009. The 2018 updated guidance on consensus of an expert panel, without formal system- chronic hepatitis B (CHB) includes (1) updates on atic review or use of the Grading of Recommendations treatment since the 2016 HBV guidelines (notably the Assessment, Development, and Evaluation system. use of tenofovir alafenamide) and guidance on (2) The 2018 guidance is based upon the following: screening, counseling, and prevention; (3) specialized (1) formal review and analysis of published literature virological and serological tests; (4) monitoring of on the topics; (2) World Health Organization guid- untreated patients; and (5) treatment of hepatitis B in ance on prevention, care, and treatment of CHB(5); and special populations, including persons with viral coin- (3) the authors’ experience in acute hepatitis B and CHB. fections, acute hepatitis B, recipients of immunosup- Intended for use by health care providers, this guid- pressive therapy, and transplant recipients. ance identifies preferred approaches to the diagnostic, The AASLD 2018 Hepatitis B Guidance provides therapeutic, and preventive aspects of care for patients a data-supported approach to screening, prevention, with CHB. As with clinical practice guidelines, it pro- diagnosis, and clinical management of patients with vides general guidance to optimize the care of the Abbreviations: AFP, alpha-fetoprotein; ALT, alanine aminotransferase; anti-HBc, antibody to hepatitis B core antigen; anti-HBe, antibody to hepa- titis B e antigen; anti-HBs, antibody to hepatitis B surface antigen; ARVT, antiretroviral therapy; AST, aspartate aminotransferase; cccDNA, cova- lently closed circular DNA; CHB, chronic hepatitis B; DAA, direct-acting antiviral; HBeAg, hepatitis B e antigen; HBIG, hepatitis B immune globulin; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; HCWs, health care workers; HDV, hepatitis D virus; HIV, human immunodeficiency virus; IFN, interferon; IFN-a, interferon-alfa; NA, nucleos(t)ide analogue; peg- IFN, peginterferon; peg-IFN-a, pegylated interferon-alfa; qHBsAg, quantitative hepatitis B surface antigen; TAF, tenofovir alafenamide; TDF, teno- fovir disoproxil fumarate; ULN, upper limits of normal; US, ultrasonography. Received January 11, 2018; accepted January 11, 2018. 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. Copyright VC 2018 by the American Association for the Study of Liver Diseases. View this article online at wileyonlinelibrary.com. DOI 10.1002/hep.29800 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. 1560 HEPATOLOGY, Vol. 67, No. 4, 2018 TERRAULT ET AL. majority of patients and should not replace clinical similar 48-week responses, with serum HBV DNA judgement for a unique patient. This guidance does <29 IU/mL in 64% versus 67%, alanine aminotrans- not seek to dictate a “one size fits all” approach for the ferase (ALT) normalization in 72% versus 67%, management of CHB. Clinical considerations may jus- HBeAg loss in 14% versus 12%, and hepatitis B sur- tify a course of action that differs from this guidance. face antigen (HBsAg) loss in 1% versus 0.3% in the TAF and TDF groups, respectively.(17) Week 96 follow-up results likewise showed that 73% and 75% Interim Data Relevant to had serum HBV DNA <29 IU/mL, 22% and 18% the AASLD 2018 Hepatitis lost HBeAg, and 1% and 1% lost HBsAg in TAF and TDF patients, respectively.(6) B Guidance Analogously, a phase 3 trial of 426 HBeAg-negative patients (21% with past NA therapy) randomized to Since the publication of the 2016 AASLD Hepatitis TAF 25 mg daily or TDF 300 mg daily in a 2:1 ratio B Guidelines, tenofovir alafenamide (TAF) has been found comparable 48-week normalization in 83% ver- approved for treatment of CHB in adults. TAF joins sus 75% in the TAF and TDF groups, respectively. the list of preferred HBV therapies, along with enteca- However, no patient in either group lost HBsAg.(18) vir, tenofovir disoproxil fumarate (TDF), and peginter- Week 96 follow-up results also showed serum HBV (6-16) feron (peg-IFN; Tables 1 and 2) (section: Updated DNA <29 IU/mL in 90% of TAF patients and 91% Recommendations on the Treatment of Patients of TDF patients, with 1 TAF-treated patient losing With Chronic Hepatitis B). Additionally, studies on HBsAg.(7) The approved dose of TAF is 25 mg orally the use of TDF for prevention of mother-to-child trans- once-daily, with no dose adjustment needed unless cre- mission led to TDF being elevated to the level of pre- atinine clearance is <15 mL/min. ferred therapy in this setting (section 1C of Screening, In these phase 3 studies, TAF had significantly less Counseling, and Prevention of Hepatitis B). decline than TDF in bone density and renal function TAF, like TDF, is a nucleotide analogue that inhib- at 48 weeks of treatment. In HBeAg-positive patients, its reverse transcription of pregenomic RNA to HBV the mean decline in the estimated glomerular filtration DNA. TAF is more stable than TDF in plasma and rate was 20.6 mL/min for TAF patients, whereas the delivers the active metabolite to hepatocytes more effi- decline was 25.4 mL/min in TDF patients ciently, allowing a lower dose to be used with similar (P < .0001). In HBeAg-negative patients, the mean antiviral activity, less systemic exposure, and thus decline in the estimated glomerular filtration rate was decreased renal and bone toxicity. 21.8 mL/min in TAF patients, whereas the decline A phase 3 trial of 873 hepatitis B e antigen for TDF patients was 24.8 mL/min (P 5 .004).(17,18) (HBeAg)-positive patients (26% with past nucleos In hip and spine bone mineral density measurements, (t)ide analogue [NA] therapy) randomized to TAF the adjusted percentage difference in spine bone min- 25 mg daily or TDF 300 mg daily in a 2:1 ratio found eral density for TAF versus TDF was 1.88% (95% ARTICLE INFORMATION: From the 1Division of Gastroenterology/Hepatology, University of California San Francisco, San Francisco, CA; 2Division of Gastroenter- ology and Hepatology, University of Michigan, Ann Arbor, MI; 3Liver Diseases and Hepatitis Program, Alaska NativeTribal Health Con- sortium, Anchorage, AK; 4Division of Gastroenterology, Corporal Michael J. Crescenz VA Medical Center & University of Pennsylvania Perelman School of Medicine, Philadelphia, PA; 5Department of General Internal Medicine, The University of Texas MD Anderson Can- cer Center, Houston, TX; 6Division of Gastroenterology, Hepatology and Nutrition, Boston Children’s Hospital, Boston, MA; 7Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY; 8Ochsner Medical Center, New Orleans, LA; and 9Division of Clinical Decision Making, Tufts Medical Center, Tufts University School of Medicine, Boston, MA. ADDRESS CORRESPONDENCE AND REPRINT REQUESTS TO: Norah Terrault, M.D., M.P.H. Room S-357 Division of Gastroenterology/Hepatology, San Francisco, CA 94143-0358 University of California San Francisco E-mail: [email protected] 513 Parnassus Avenue Tel: 11-415-476-2227 1561 TERRAULT ET AL. HEPATOLOGY, April 2018 TABLE 1. Approved Antiviral Therapies in Adults and Children Dose in Use in Pregnancy Potential Drug Adults* Children* Category† Side Effects† Monitoring on Treatment‡ Preferred Peg-IFN-a-2a 180 mcg 1 year dose: C Flu-like symptoms, fatigue, Complete blood count (monthly to every (adult) weekly 6 million IU/m2 mood disturbances, 3 months) IFN-a-2b three times cytopenia, autoimmune TSH (every 3 months) (children) weekly§ disorders in adults, Clinical monitoring for autoimmune, anorexia and weight ischemic, neuropsychiatric, and loss in children infectious complications Entecavir 0.5 mg 2 years dose: C Lactic acidosis Lactic acid levels if there is clinical dailyk weight-based (decompensated concern to 10-30 kg;
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