Guidelines for the Prevention, Care and Treatment of Persons with Chronic Hepatitis B Infection. The UW HTC is funded by the Centers for Disease Control and Prevention (CDC). Amy S. Tang, MD But in some people, it turns into a chronic infection that never goes away. Severe lactic acidosis during treatment of chronic hepatitis B with entecavir in patients with impaired liver function. Chon YE, Choi EH, Song KJ, Park JY, Kim do Y, Han KH, et al. Several disease phases are recognized on the basis of serum aminotransferase levels, hepatitis B e. For broader issues related to diagnosis, surveillance, and prevention as well as treatment in special populations (e.g., liver transplant recipients) that are not addressed by this guideline, the previous AASLD guideline2 and recent World Health Organization (WHO) guideline3 are excellent additional resources. Cholongitas E, Papatheodoridis GV, Goulis J, Vlachogiannakos J, Karatapanis S, Ketikoglou J, et al. A previous AASLD hepatitis B practice guideline (2009)2 recommended antiviral therapy for HBeAg-negative persons until HBsAg clearance was achieved. Robert G. Gish, MD All infants born to mothers who are positive for hepatitis B surface antigen should receive hepatitis B immune globulin promptly and the hepatitis B vaccine by 24 hours of life. Laprise C, Baril JG, Dufresne S, Trottier H. Association between tenofovir exposure and reduced kidney function in a cohort of HIV-positive patients: results from 10 years of follow-up. sharing sensitive information, make sure youre on a federal Three-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B. Liaw YF, Jia JD, Chan HL, Han KH, Tanwandee T, Chuang WL, et al. Given the knowledge gap regarding long-term health outcomes with and without antiviral therapy, more RCTs with longer duration of follow-up are needed to determine whether antiviral therapy can safely be stopped in HBeAg-negative, HBV-infected persons with and without cirrhosis. There are eight approved treatments for chronic hepatitis B in the United States.2 These antiviral treatments fall into two classes: peginterferon alfa-2a agents and nucleoside/nucleotide analogues2 (Table 62,2836 ). The only clinical report of lactic acidosis with currently approved HBV antivirals was in 5 of 16 persons with decompensated cirrhosis treated with entecavir, and risk of lactic acidosis was correlated with the individual components of Model for End-Stage Liver Disease, including serum creatinine.74,75. Health care workers: Most people should receive the recommended course of action. Ott JJ, Stevens GA, Groeger J, Wiersma ST. However, data from the HIV literature support the safety of these drugs during breastfeeding. Stratification of results by treatment type (IFN and NAs, all lamivudine) yielded RR that included 1 (not significantly different from untreated controls). Clinical course of lamivudine monotherapy in patients with decompensated cirrhosis due to HBeAg negative chronic HBV infection. About 1 in 5 people with chronic hepatitis B die from it. Pegylated interferon alfa-2a (Pegasys), entecavir (Baraclude), and tenofovir are recommended as first-line treatment options.27 There are two treatment approaches: a defined treatment period with a peginterferon alfa-2a or long-term treatment with a nucleoside/nucleotide analogue. The achievement of a sustained suppression of HBV replication has been associated with normalization of serum ALT, loss of HBeAg with or without detection of (anti-HBe), and improvement in liver histology. Copyright 2023 American Academy of Family Physicians. Available evidence does not define the specific ALT and HBV DNA thresholds at which treatment should be initiated. The impact of newer nucleos(t)ide analogues on patients with hepatitis B decompensated cirrhosis. Determinants for sustained HBeAg response to lamivudine therapy. Technical remarks are added to recommendations to facilitate implementation. Management recommendations for health care personnel exposed to the HBV are summarized in Table 4.3, Approximately 1,000 cases of perinatal hepatitis B occur annually in the United States, and nearly 90% of chronic hepatitis B in infants develops in the first year of life.25 All infants born to mothers who are HBsAg positive should receive hepatitis B immune globulin promptly and the hepatitis B vaccine by 24 hours of life.25 The vaccination series should be completed, and postvaccination serologic testing should be performed at nine to 12 months of age to assess response to vaccination. In another study of 707 persons on treatment with antiviral therapy after decompensation, 423 treated persons had significantly better 5-year transplant-free survival than untreated persons (59.7% vs. 46%).112 In addition, 33.9% of treated persons were subsequently delisted. The evidence profile is summarized in Supporting Table 6.130 Additionally, in a recent multinational RCT in children ages 218, a significantly higher rate of HBeAg seroconversion plus HBV DNA <50 IU/mL was achieved with entecavir compared to placebo (24.4% vs. 2.4%; P = 0.005).131 Not all of the reviewed studies had the same primary endpoints. The newer oral medications are stronger and less likely to develop viral resistance and have very few side effects. Annually, approximately 0.5% of individuals with inactive chronic hepatitis B will have spontaneous clearance of HBsAg, and most will develop anti-HBs.2 Among adults with untreated chronic hepatitis B, the cumulative five-year incidence of cirrhosis is 8% to 20%, and the risk of HCC is 2% to 5%.2, The risk of liver-related complications is variable and influenced by a variety of host, viral, and environmental factors.2 Determining the stage of liver disease (e.g., evidence of inflammation, fibrosis) is important to guide therapeutic decisions and the need for HCC screening.2 Although liver biopsy is recommended for assessing inflammatory activity and fibrosis, noninvasive tests, such as transient elastography or a serum fibrosis panel, are also useful.2. Ceylan B, Yardimci C, Fincanci M, Eren G, Tozalgan U, Muderrisoglu C, et al. Zoutendijk R, Reijnders JG, Brown A, Zoulim F, Mutimer D, Deterding K, et al. Hepatitis B infections that last a long time may lead to serious liver diseases like cirrhosis and liver cancer. Santantonio T, Mazzola M, Iacovazzi T, Miglietta A, Guastadisegni A, Pastore G. Long-term follow-up of patients with anti-HBe/HBV DNA-positive chronic hepatitis B treated for 12 months with lamivudine. American Association for the Study of Liver Diseases . In contrast, virological breakthrough98,99 on antiviral treatment is typically associated with viral resistance and warrants a change of therapy.100. Benaboud S, Pruvost A, Coffie PA, Ekouvi DK, Urien S, Arriv E, et al. FOIA The HBV has 10 genotypes (A through J) and more than 30 subtypes.4. Globally, an estimated 240 million persons have CHB with a varying prevalence geographically, highest in Africa and Asia.4 In the United States, the National Health and Nutrition Examination Survey (1999 to 2008) identified approximately 704,000 adults with CHB,5 but with adjustments for hepatitis B infection among foreign-born persons, the upper estimate of CHB in the United States may be as high as 2.2 million.6 Globally, deaths from cirrhosis and hepatocellular carcinoma (HCC) were estimated at 310,000 and 340,000 per year, respectively.7 To reduce the morbidity and mortality of CHB in the United States and worldwide, there is a need for continued efforts to identify infected individuals through targeted screening, prevent new infections through vaccination, and monitor and treat those at risk for complications of their CHB, including surveillance for HCC.8,9. The Centers for Disease Control and Prevention (CDC) estimated that in 2015 there were 21,900 cases of acute hepatitis B, with an overall incidence of 1.1 cases per 100,000.1 There are an estimated 850,000 to 2.2 million individuals in the United States with chronic hepatitis B.1,2 Approximately 25% of children and 15% of adults with chronic hepatitis B die prematurely from hepatocellular carcinoma (HCC) or cirrhosis.3 However, treatment reduces morbidity and mortality from the disease. An official website of the United States government. The clinical significance of persistently normal ALT in chronic hepatitis B infection. Studies of therapy in children typically include only HBeAg-positive children, and most have required at least mildly elevated ALT values (>1.3 times the ULNs, with 30/U/L used as the ULN).129 Surrogate endpoints have been used, because the hard endpoints of cirrhosis, HCC, and death are very rare within the several year follow-up incorporated into these clinical trials. This guideline focuses on using antiviral therapy in chronic HBV infection and does not address other related and important issues, such as screening, prevention, and surveillance. Long-term effect of antiviral therapy on disease course after decompensation in patients with hepatitis B virus-related cirrhosis. Health care workers: Be prepared to help patients make a decision that is consistent with their values using decision aids and shared decision making. Amy Trang, PhD, M.Ed. During recovery from acute hepatitis B, HBeAg becomes undetectable in the serum, while antibodies to HBeAg (anti-HBe) become detectable. These drugs, which target HBV by inhibiting the viral polymerase, are the most commonly used antivirals for treating chronic hepatitis B. The drug is available in sachets that can be easily carried in pocket or wallet. Most children with CHB are HBeAg positive, and viremia levels are typically high. Immune-tolerant HBV-infected children have normal or minimally elevated ALT levels. You can get it from: having vaginal, anal, or oral sex (using a condom or dental dam during sex can help prevent it) sharing toothbrushes and razors (blood on them can carry hepatitis B) sharing needles for shooting drugs, piercings . Most babies who get hepatitis B during birth develop chronic infection, unless they get treated right away. The objective of HBV treatment is to prevent fibrosis progression and liver-related complications through achievement of sustained suppression of viremia.2 In those with significant inflammation and/or fibrosis on histology and/or elevated ALT in association with elevated HBV DNA levels, the risk of liver-related complications is highest and the rationale for treatment can be made. McMahon BJ. Fattovich G. Natural history and prognosis of hepatitis B. Yim HJ, Lok AS. Shorter durations and lower doses of peginterferon alfa-2a are associated with inferior hepatitis B e antigen seroconversion rates in hepatitis B virus genotypes B or C. Buster EH, Hansen BE, Lau GK, Piratvisuth T, Zeuzem S, Steyerberg EW, et al. HBV DNA levels, ALT levels, and HBeAg status are among the most important determinants of risk of progression to cirrhosis,15,16 whereas HBV DNA levels (>2,000 IU/mL), HBeAg status, and cirrhosis are key predictors of HCC risk.1518 A biological gradient of risk has been shown in adults with HBV DNA levels above 2,000 IU/mL; a higher HBV DNA level is associated with progressively higher rates of cirrhosis and HCC.15, Host, Viral/Disease, and Environmental Factors Associated With Cirrhosis and HCC, The initial evaluation of persons with CHB should include a thorough history and physical examination, with special emphasis on risk factors for coinfection, alcohol use, and family history of HBV infection and liver cancer. There are six therapeutic agents approved for the treatment of adults with CHB in the United States and five therapeutic agents approved for the treatment of children with CHB (Table 4). A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. Dr. Bzowej received grants from Gilead, Synageva, and Ocera. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. The latter group likely included persons with HBeAg-positive immune active disease, a group recommended for antiviral therapy. The majority of perinatal transmission is thought to occur at delivery, given that a combination of hepatitis B immunoglobulin and vaccination given within 12 hours of birth has reduced the rate of perinatal transmission from >90% to <10%.14 Of the vaccine and hepatitis B immunoglobulin failures, almost all occur in HBeAg-positive women with very high viral loads, generally above 2 105107 IU/mL.115118 The oral antiviral drugs are pregnancy class C except for telbivudine (class B) and tenofovir (class B). As a result, drug labels recommend avoidance of breastfeeding when on these drugs. However, tenofovir is considered a preferred choice, owing to its antiviral potency, the available safety data of use during pregnancy, and concerns for resistance with the other antiviral agents. Shapiro RL, Holland DT, Capparelli E, Lockman S, Thior I, Wester C, et al. However, tenofovir therapy has been associated with acute and chronic kidney disease involving proximal tubular dysfunction with Fanconi-like syndrome (metabolic acidosis, hypophosphatemia, and glycosuria) and nephrogenic diabetes insipidus, based mostly on studies from HIV-infected persons.25,68,69 Long-term tenofovir therapy in HIV-infected persons has been associated with reduced bone density and osteomalacia.70 However, there was no increased risk for severe proteinuria, hypophosphatemia, or fractures associated with tenofovir therapy in HIV-infected persons in a systematic review and meta-analysis of 17 RCTs.71, Renal dysfunction, hypophosphatemia, and Fanconi-like syndrome have also been reported in HBV-infected persons on tenofovir. Also searched were the Cochrane database and Essential Evidence Plus. Among 17 studies of interventions in immune-tolerant adults, only two examined adults with ALT less than ULNs, whereas most used ALT less than 2 times ULNs for inclusion. National Library of Medicine Collectively, these foregoing studies suggest that virus suppression (<2,000 IU/mL) and ALT normalization may be sustained in almost half of the HBeAg-negative persons with treatment duration longer than 2 or more years. The nucleoside/nucleotide analogues approved in the United States for treatment of chronic hepatitis B are adefovir (Hepsera), entecavir, lamivudine (Epivir HBV), telbivudine (no longer available in the United States), tenofovir disoproxil fumarate (Viread), and tenofovir alafenamide (Vemlidy). Members of the committee include Raphael B. Merriman, M.D., F.A.C.P., F.R.C.P.I. Guidance. It aims to improve care for people with hepatitis B by specifying which tests and treatments to use for people of different ages and with different disease severities. Anna S. Lok, MD It begins as an acute infection that's usually short-lived. Side effects of long-term oral antiviral therapy for hepatitis B. It is recognized that the normal ALT levels of healthy adults are 30 U/L for males and 19 U/L for females.19 Thus, using these ALT cutoffs for normal, the recommendation to consider treatment of adults with ALT values of 2 times the ULN (>60 U/L for males and >38 U/L for females) is more inclusive than the ALT criteria used in the clinical trials. Lim YS, Yoo BC, Byun KS, Kwon SY, Kim YJ, An J, et al. THAD WILKINS, MD, MBA, RICHARD SAMS, MD, MA, AND MARY CARPENTER, PharmD, See related AFP Community Blog post: Family Doctors Can Easily Treat Hepatitis B "In-House". Bethesda, MD 20894, Web Policies A network meta-analysis to compare antiviral therapies was not feasible owing to the small number of RCTs per analysis. Histological findings are minimal in these children, as in young adults.47 ALT values are typically normal after spontaneous HBeAg seroconversion, defining the inactive carrier state, and in this phase of chronic infection, liver disease does not progress. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. Lok AS, Trinh H, Carosi G, Akarca US, Gadano A, Habersetzer F, et al. Informed consent should be obtained from the source person in accordance with state laws, and his or her blood should be obtained and tested for HBsAg. Buster EH, Flink HJ, Cakaloglu Y, Simon K, Trojan J, Tabak F, et al. Long-term follow-up of treated children is needed to validate the use of intermediate biochemical and virological outcomes for clinically important outcomes. The initial evaluation of individuals with chronic hepatitis B includes a complete history and examination. Hepatitis B is a viral infection that affects your liver. Given the lack of evidence of benefit to those with ALT Treatment Of Tension Headache Red Viagra, Articles H