HEPATITIS B VIRUS (HBV) IN PREGNANT WOMEN (Screening, Immunization, and Treatment)
Evidence Statement
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Updated 9/30/11
Evidence StatementClinical Preventive Service RecommendationsPreventive Services Task Force RecommendationScreeningThe U.S. Preventive Services Task Force (USPSTF) strongly recommends screening for hepatitis B virus (HBV) infection in pregnant women at their first prenatal visit.1 Evidence Rating: A (Strongly Recommended/ Good Evidence) The USPSTF found good evidence that universal prenatal screening for HBV infection using hepatitis B surface antigen test (HBsAg). HBsAg testing substantially reduces prenatal transmission of HBV and the subsequent development of chronic HBV infection. The current practice of vaccinating all infants against HBV infection and post-exposure prophylaxis with hepatitis B immune globulin administered at birth to infants of HBV-infected women substantially reduces the risk for acquiring HBV infection.1 Immunization The U.S. Preventive Services Task Force (USPSTF) defers to the Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC) on recommendations surrounding immunization. CDC RecommendationAdvisory Committee on Immunization Practices (ACIP)Screening The Advisory Committee on Immunization Practices (ACIP) recommends that all pregnant women be tested routinely for hepatitis B surface antigen (HBsAg) during an early prenatal visit (i.e., first trimester) in each pregnancy, even if they have been previously vaccinated or tested. Women who were not screened prenatally, those who engage in behaviors that put them at high risk for infection (e.g., injection-drug use, having had more than one sex partner in the previous 6 months or an HBsAg-positive sex partner, evaluation or treatment for a sexually transmitted infection [STI], or recent or current injection-drug use) and those with clinical hepatitis should be tested at the time of admission to the hospital for delivery.2,3 Immunization The ACIP further recommends the hepatitis B vaccine for pregnant women at risk for hepatitis B virus infection. Pregnant women who are identified as being at risk for HBV infection during pregnancy (see list of risk factors in preceding paragraph) should be vaccinated. Pregnant women at risk for HBV infection during pregnancy should be counseled concerning other methods to prevent HBV infection.2,3 Management of Exposed or Potentially Exposed Infants/Treatment The ACIP recommends that all infants born to HBsAg-positive women should receive single-antigen hepatitis B vaccine and hepatitis B immune globulin prophylaxis (HBIG) (0.5 mL) within the first 12 hours following the birth, administered at different injection sites.2,3 Women admitted for delivery without documentation of HBsAg test results should have blood drawn and tested as soon as possible after admission. While test results are pending, all infants born to women without documentation of HBsAg test results should receive the first dose of single-antigen hepatitis B vaccine (without HBIG) within 12 hours following the birth.2,3 A summary of guidelines for the immunization of pregnant women can be found online (www.cdc.gov/nip/publications/preg_guide.htm). Evidence Rating: Expert Consensus
The Value of PreventionEconomic Burden of Condition/DiseaseThe economic burden of hepatitis B infection depends on whether the infection is acute or chronic and what treatment is required. The direct medical cost of outpatient treatment for symptomatic acute hepatitis B has been estimated at $272 per occurrence, while the cost of hospitalization for symptomatic hepatitis B infection is $8,080 per occurrence (both in year 2000 dollars).8 If a patient develops liver disease as a result of chronic HBV infection, the direct medical cost of treatment is estimated to be $59,308 (before discounting)8 and the average cost of a liver transplant was $163,438 (in year 2008 dollars).9Workplace Burden of Condition/DiseaseHBV is also responsible for disability costs, costs associated with work-loss and absenteeism, and other indirect costs.Economic Benefit of Preventive InterventionScreening pregnant women for HBV, and treating the infants of HBV-positive women with post-exposure hepatitis B immune globulin prophylaxis and HBV vaccination can dramatically reduce the incidence of perinatal HBV transmission and thus the number of infants who become chronically infected with hepatitis B.2 The additional recommended step of vaccinating all infants with HBV at birth also serves as a safety net to prevent perinatal hepatitis B transmission.2 The averted direct and indirect costs of illness from each case of HBV prevented constitute the predominant economic benefit of the preventive intervention. From a societal perspective, prevention of perinatal HBV infection was estimated to save $41.8 million (in year 1993 dollars) in medical and work-loss costs.10Estimated Cost of Preventive InterventionIn 2004, the private-sector cost of11:
Estimated Cost of TreatmentThe cost of therapeutic treatment of chronic hepatitis B varies according to the medication required; the annual cost of interferon therapy was $5,589 (in year 2011 dollars).12Cost-Effectiveness and/or Cost-Benefit Analysis of Preventive InterventionThe estimated cost of preventing a perinatal HBV infection is $164 per year of life saved, (in year 1993 dollars).10 In comparison to other preventive interventions and to commonly accepted cost-effectiveness benchmarks, hepatitis B screening is highly cost-effective.Condition / Disease Specific InformationEpidemiology of Condition/DiseaseOver 1 million people in the United States are chronic carriers of HBV.4 In 2003, an estimated 73,000 new HBV infections were reported in the United States.4 Hepatitis infection can lead to liver disease, including liver cancer, which without treatment can result in death. Between 4,000 and 5,000 chronic carriers of HBV die each year in the United States.4 Hepatitis B can be treated with medications if diagnosed early, but some individuals do not respond to treatment and require liver transplants to survive.The severity of hepatitis B infection depends on the age at which an individual becomes infected and the presence of other co-morbid conditions such as alcohol abuse, HIV/AIDS, or other types of liver disease.6 Most adolescents and adults with acute HBV infections recover fully, but 30% of children aged 1 to 5 years and 2% to 6% of adults become chronically infected with hepatitis B.7 Immunization against HBV is the single most effective way of preventing hepatitis B infection and its consequences.2 Condition/Disease Risk FactorsThe risk factors for hepatitis B include intravenous drug use, concurrent infection with a sexually transmitted infection (STI), multiple sexual partners, household contact with an infected person, and being a healthcare worker with exposure to bodily fluids. However, 30% to 40% of infected individuals have no identified risk factors.6Infants can contract hepatitis B from an infected woman during labor and delivery and as many as 90% of infants infected through perinatal transmission become chronic carriers of HBV.2 Preventive Intervention InformationPreventive Intervention: Purpose of Screening and ImmunizationScreening pregnant women for HBV, immunizing women at high-risk of HBV, and treating the infants of HBV-positive women with post-exposure hepatitis B immune globulin prophylaxis and HBV vaccination, can dramatically reduce perinatal HBV transmission and, thus, the number of infants who become chronically infected with hepatitis B.2Benefits and Risks of InterventionThe benefits of screening, immunization, and treatment are substantial; an untreated maternal hepatitis B viral infection may result in severe disease for the woman and chronic infection for the newborn.2There is no apparent risk of adverse effects for developing fetuses when a hepatitis B vaccine is administered to a pregnant woman.3 Initiation, Cessation, and IntervalScreeningScreening for hepatitis B should be conducted at the first prenatal visit in each pregnancy. Women at increased risk of acquiring HBV may be screened again during the third trimester and/or during labor and delivery and should be offered the hepatitis B vaccine. Household contacts of women with a positive HBsAg test should also be screened for HBV infection. Women admitted for delivery without documentation of HBsAg test results should have blood drawn and tested as soon as possible after admission.2 Immunization HBV immunization should be given to high-risk pregnant women as deemed appropriate by the clinician.2 All infants should receive their first hepatitis B immunizations at the time of birth. Infants born to HBV-infected women should be immunized and given immune globulin within 12 hours of birth. Infants born to women with unknown HBsAg status should receive one dose of single-antigen hepatitis B vaccine (without HBIG) within 12 hours of birth, while awaiting the woman's test results.2 Treatment Post-exposure hepatitis B immune globulin prophylaxis should be given, as medically indicated.2 Intervention ProcessScreeningThe principal screening test for detecting an HBV infection (acute or chronic) is the identification of HBsAg in the blood. Testing methods include the HBsAg Immunoassay and the "rapid test," an assay that detects HBsAg and the hepatitis B e-antigen HBeAg simultaneously. Immunization HBV immunizations are administered via injection. Treatment Post-exposure hepatitis B immune globulin prophylaxis. Treatment InformationPlease refer to the "Intervention Process" section for information on preventive treatment.Strength of EvidenceThe level of evidence supporting the recommendations contained in this section is described below.Evidence-Based Research: The U.S. Preventive Services Task Force (USPSTF) Strength of Evidence: A (Strongly Recommended/Good Evidence) The USPSTF found good evidence that universal prenatal screening for HBV infection using HBsAg substantially reduces prenatal transmission of HBV and the subsequent development of chronic HBV infection. The current practice of vaccinating all infants against HBV infection and post-exposure prophylaxis with hepatitis B immune globulin administered at birth to infants of HBV-infected women substantially reduces the risk for acquiring HBV infection.1 The American Academy of Family Physicians (AAFP) Strength of Evidence: SR (Strongly Recommended) AAFP strongly recommends screening for hepatitis B virus (HBV) infection in pregnant women at their first prenatal visit.5 Good quality evidence exists which demonstrates the substantial net benefit of screening for HBV over harm; the intervention is perceived to be cost-effective and acceptable to nearly all patients.5 Summary Plan Description Language: Hepatitis B Virus (HBV) (Screening)Covered ScreeningHepatitis B screening is a covered benefit for all pregnant women. Coverage includes the use of all validated screening tools, including the HBsAg Immunoassay and the "rapid test."Initiation, Cessation, and IntervalAverage-risk women should be screened once, ideally at the first prenatal care visits. Additional screenings are covered for women at increased risk of acquiring HBV.Summary Plan Description Language: Hepatitis B Virus (HBV) (Immunization)Covered ImmunizationsAll types and brands of hepatitis B immunization are covered.Initiation, Cessation, and IntervalImmunizations may be given at any time during pregnancy, as deemed appropriate by the clinician.Summary Plan Description Language: Hepatitis B Virus (HBV) (Treatment)Covered TreatmentTreatment for infants born to hepatitis B (HBV)-positive women includes:
Initiation, Cessation, and IntervalImmune globulin and HBV immunizations are covered, as medically indicated.CPT Codes
Other Information and ResourcesBusiness Group Resource(s)CDC ResourceAuthor(s)Campbell KP, Lindley MC, Lentine D, Bhatt A. Hepatitis B virus evidence-statement: screening, immunization, and treatment. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser's Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006. Updated 2011.References
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