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Try out PMC Labs and tell us what you think. Learn More. Division of Gastroenterology, Corporal Michael J. The updated guidance on chronic hepatitis B CHB includes i updates on treatment since the HBV guideline notably the use of tenofovir alafenamide and guidance on ii screening, counseling, and prevention; iii specialized virologic and serologic tests; iv monitoring of untreated patients; and v treatment of hepatitis B in special populations, including persons with viral coinfections, acute hepatitis B, recipients of immunosuppressive therapy, and transplant recipients.

It differs from the published AASLD guideline 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 — 4. 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. 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. Clinical considerations may justify a course of action that differs from this guidance.

References: 6 — Tenofovir alafenomide is more stable than TDF in plasma and delivers the active metabolite to hepatocytes more efficiently, allowing a lower dose to be used with similar antiviral activity, less systemic exposure, and thus decreased renal and bone toxicity.

However, no patient in either group lost HBsAg In these phase 3 studies, TAF had ificantly less decline than TDF in bone density and renal function at 48 weeks of treatment. In hip and spine bone mineral density measurements, the adjusted percentage difference in spine bone mineral density for TAF vs TDF was 1.

While longer-term data in HBV-monoinfected patients are lacking, particularly with respect to the impact on clinical outcomes such as renal disease and fracture risk, the current safety profile of TAF combined with evidence of similar antiviral efficacy led to its inclusion among the preferred HBV therapies for those patients requiring treatment. In studies of up to 96 weeks, a switch to TAF vs continued TDF treatment as part of an antiretroviral regimen was associated with improvements in proteinuria, albuminuria, proximal renal tubular function mostly within the first 24 weeks , and bone mineral density The presence of HBsAg establishes the diagnosis of hepatitis B.

Chronic vs acute infection is defined by the presence of HBsAg for at least 6 months. In developed countries, the prevalence is higher among those who immigrated from high- or intermediate-prevalence countries and in those with high-risk behaviors 22 , Hepatitis B virus is transmitted by perinatal, percutaneous, and sexual exposure and by close person-to-person contact presumably by open cuts and sores, especially among children in hyperendemic areas 24 , In most countries where HBV is endemic, perinatal transmission remains the most important cause of chronic infection.

Perinatal transmission also occurs in nonendemic countries including the United States , mostly in children of HBV-infected mothers who do not receive appropriate HBV immunoprophylaxis at birth. The majority of children and adults with CHB in the United States are immigrants, have immigrant parents, or became exposed through other close household contacts 26 , HBV can survive outside the body for prolonged periods In addition, immunosuppressed persons are more likely to develop chronic HBV infection after acute infection Table 3 displays those at risk for CHB who should be screened for HBV infection and immunized if seronegative 23 , 35 , Alternatively, antibody to hepatitis B core antigen anti-HBc can be utilized for screening as long as those who test positive are further tested for both HBsAg and anti-HBs to differentiate current infection from HBV exposure.

HBV vaccination does not lead to anti-HBc positivity. Sources: 23 , 35 , Some persons may test positive for anti-HBc but not HBsAg; they may or may not also have anti-HBs, with the prevalence depending on local endemicity or the risk group 37 , Among intermediate- to high-risk populations, the most common reason is exposure to HBV infection; the majority of these persons recovered from acute HBV infection earlier in life and anti-HBs titers have waned to undetectable levels, but some had been chronically infected with HBV for decades before clearing HBsAg.

Much less commonly with new, more specific anti-HBc tests, anti-HBc may be a false-positive test result, particularly in persons from low-prevalence areas with no risk factors for HBV infection. Earlier anti-HBc enzyme immunoassay and radioimmunoassay tests were less specific, more frequently yielding false positive Anti-HBc may be the only marker of HBV infection during the window phase of acute hepatitis B; these persons should test positive for anti-HBc immunoglobulin M 37 , Because of the risk for HBV transmission, screening for anti-HBc occurs routinely in blood donors and, if feasible, in organ donors Since the original anti-HBc studies, the specificity of anti-HBc tests has improved to Individuals with HIV infection or those about to undergo HCV or immunosuppressive therapy are at risk for potential reactivation if they have preexisting HBV and should be screened for anti-HBc 37 , Additionally repeat anti-HBc testing can be performed over time, particularly in blood donors in whom subsequent anti-HBc negativity suggests an initial false-positive result 37 , Although reports vary depending on the sensitivity and specificity of the anti-HBc test used and HBV prevalence in the study population, the minority of patients have an anamnestic response to HBV vaccination, with the majority having a primary antibody response to hepatitis B vaccination similar to persons without any HBV seromarkers 23 , Thus, vaccination could be considered reasonable for all screening indications in Table 3.

Thus, limited data suggest that vaccination may be considered 48 , 52 , When considering the benefit of using an anti-HBc—positive donor organ with possible occult HBV infection, the harm of hepatitis B transmission must be weighed against the clinical condition of the recipient patient.

While persons who are positive for anti-HBc but negative for HBsAg are at very low risk of HBV reactivation, the risk can be substantial when chemotherapeutic or immunosuppressive drugs are administered singly or in combination see Screening, Counseling, and Prevention of Hepatitis B, section 6D. Thus, all persons who are positive for anti-HBc with or without anti-HBs should be considered potentially at risk for HBV reactivation in this setting. Screening for anti-HBc to determine prior exposure is not routinely recommended but is an important test in patients who have HIV infection, who are about to undergo HCV or anticancer and other immunosuppressive therapies or renal dialysis, and in donated blood or, if feasible, organs see Screening, Counseling, and Prevention of Hepatitis B, section 6D.

Patients with chronic HBV infection should be counseled regarding lifestyle modifications and prevention of transmission as well as the importance of lifelong monitoring. No specific dietary measures have been shown to have any effect on the progression of CHB per se, but metabolic syndrome and fatty liver contribute to liver-related morbidity 54 , Ingestion of more than 7 drinks per week for women and more than 14 drinks per week for men are associated with increased risk of cirrhosis and HCC 56 , Studies evaluating the risk of lesser amounts of alcohol intake are sparse 58 , but the conservative approach is to recommend abstinence or minimal alcohol ingestion 59 , Individuals with CHB should be immunized against hepatitis A if not already immune HBsAg-positive persons should be counseled regarding transmission to others see Table 5.

Because of increased risk of acquiring HBV infection, household members and sexual partners should be vaccinated if they test negative for HBV serologic markers. For casual sex partners or steady partners who have not been tested or have not completed the full immunization series, barrier protection methods should be employed.

Transmission of HBV from infected health care workers to patients has been shown to occur in rare instances For persons with CHB who are health care workers, the Centers for Disease Control and Prevention recommends that those who perform exposure-prone procedures should seek counseling and advice from an expert review panel Since , the US Department of Justice has ruled that it is unlawful for medical and dental schools to exclude applicants who are HBsAg positive. No special arrangements need to be made for HBV-infected children in the community other than practicing universal precautions in daycare centers, schools, sports clubs, and camps.

Use barrier protection during sexual intercourse if partner is not vaccinated or is not naturally immune. Should not be excluded from daycare or school participation and should not be isolated from other children. Only HBsAg-positive health care workers and students whose job requires performance of exposure-prone procedures are recommended to seek counseling and advice from an expert review panel at their institution. No special arrangements are indicated for HBV-infected children in the community other than practicing universal precautions in daycare centers, schools, sports clubs, and camps.

Optimization of body weight and treatment of metabolic complications, including control of diabetes and dyslipidemia, are recommended to prevent concurrent development of metabolic syndrome and fatty liver. Screening for anti-HBc is not routinely recommended except in patients who have HIV infection or who are about to undergo HCV therapy or immunosuppressive treatment. Persons who are positive only for anti-HBc and who are from an area with low endemicity with no risk factors for HBV should be given the full series of hepatitis B vaccine.

Persons who are positive only for anti-HBc and have risk factors for hepatitis B Table 3 are not recommended for vaccination unless they are HIV positive or immunocompromised. All pregnant women should be screened for HBsAg. It has been postulated that the rapid decrease in cortisol levels characteristic of the postpartum state is analogous to the steroid withdrawal therapy that has been used to elicit seroconversion. Although the flares are often mild and resolve spontaneously, cases of acute liver failure have been described in the peripartum period 66 — Extending third trimester antiviral therapy from 2 to 12 weeks postpartum did not protect against postpartum flares in one study 68 , supporting the AASLD guideline recommendation that antiviral therapy given for prevention of mother-to-child transmission be discontinued at the time of delivery or up to 4 weeks postpartum 1.

Prior systematic review of any antiviral therapy in the third trimester showed a ificant reduction in perinatal transmission of HBV 4 with lamivudine, telbivudine, or TDF, but TDF is the preferred choice owing to its antiviral potency and concerns for resistance with the other antiviral agents. Two recent randomized control trials of TDF vs no antiviral treatment in the third trimester confirmed ificant reductions in risk of mother-to-child transmission of hepatitis B with TDF in women with a high level of HBV DNA 69 , Elevated maternal creatine kinase levels were more frequent in TDF-treated vs untreated women in one study, though none were assessed as clinically ificant Both studies found no difference in the rates of prematurity, congenital malformations, or Apgar scores.

Additional data on infant safety including bone growth from studies of pregnant women receiving antiretroviral therapy found no increase in adverse events among TDF-exposed vs unexposed infants 71 — Whether invasive procedures during pregnancy, such as amniocentesis, increase the risk of HBV infection in the infants is unclear. Two studies including 21 and 47 HBsAg mother-infant pairs respectively concluded that the risk of HBV transmission by amniocentesis is low Therefore, the risk of mother-to-child transmission must be considered when assessing the potential benefit of amniocentesis in highly viremic women.

Although antiviral drug labels do not recommend breastfeeding when taking these drugs, clinical studies support the safety of these drugs during breastfeeding 77 , Vaccination against HBV is both safe and efficacious during pregnancy In addition, titers of the passively transferred maternal antibody to newborns wane over time, as would be expected without the addition of active vaccination An accelerated vaccination schedule has been shown to be feasible and efficacious in high-risk pregnant women Chronic HBV infection does not usually affect the outcome of pregnancy unless the mother has cirrhosis or advanced liver disease.

However, extra care is necessary to evaluate the mother and to ensure that the infant receives hepatitis B immune globulin and a birth dose of HBV vaccine. HBV vaccination is safe in pregnancy, and pregnant women who are not immune to or infected with HBV should receive this vaccine series. Women who meet standard indications for HBV therapy should be treated. HBV-infected pregnant women who are not on antiviral therapy as well as those who stop antiviral at or early after delivery should be monitored closely for up to 6 months after delivery for hepatitis flares and seroconversion.

Long-term follow up should be continued to assess need for future therapy. The potential risk of mother-to-child transmission of HBV with amniocentesis should be included in the risk of harms vs benefits discussion in HBsAg-positive mothers with high level viremia. HBV-infected pregnant women with cirrhosis should be managed in high-risk obstetrical practices and treated with TDF to prevent decompensation. Recommendations for vaccination are outlined in the Centers for Disease Control and Prevention and Advisory Committee on Immunization Practices guidelines 35 , Follow-up testing is recommended for those who remain at risk of infection, such as health care workers, infants of HBsAg-positive mothers, sexual partners of persons with CHB, chronic hemodialysis patients, and immunocompromised persons, including those with HIV.

Furthermore, annual testing of hemodialysis patients is recommended since immunity wanes rapidly in these individuals who are at a high risk of continued exposure to HBV. Booster doses are not indicated in immunocompetent individuals if the primary vaccination series is completed, as long-term follow-up studies indicated that immune memory persists despite declining anti-HBs levels For those who are nonresponders to the initial vaccination series, a second series of 0-, 1-, and 6-month vaccination is recommended This includes bites, needlesticks, sexual contacts, and sexual assaults.

Immunoprophylaxis should be administered within 24 hours of exposure. Studies are limited on the maximum interval after exposure during which postexposure prophylaxis is effective, but the interval is unlikely to exceed 7 days for percutaneous exposures and 14 days for sexual exposures. The Centers for Disease Control and Prevention has updated guidelines for vaccination and postexposure prophylaxis for health care workers HCW Infants born to women whose HBsAg status is unknown should also receive prompt initiation of vaccination at birth.

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