Final Recommendation Statement
Hepatitis B Virus Infection in Pregnant Women: Screening
July 23, 2019
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
The US Preventive Services Task Force (USPSTF) makes recommendations about the effectiveness of specific clinical preventive care services for patients without obvious related signs or symptoms.
It bases its recommendations on the evidence of both the benefits and harms of the service and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment.
The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decision making to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.
Screening for HBV infection during pregnancy identifies women whose infants are at risk of perinatal transmission. Data from a nationally representative sample showed a prevalence of maternal HBV infection of 85.8 cases per 100,000 deliveries from 1998 to 2011 (0.09% of live-born singleton deliveries in the United States).1,2 Although there are guidelines for universal infant HBV vaccination, rates of maternal HBV infection have increased annually by 5.5% since 1998.1,2 Persons infected with HBV during infancy or childhood are more likely to develop chronic infection. Chronic HBV infection increases long-term morbidity and mortality by predisposing infected persons to cirrhosis of the liver and liver cancer.
In 2009, the USPSTF reviewed the evidence for screening for HBV infection in pregnant women and issued an A recommendation.3 The USPSTF has decided to use a reaffirmation deliberation process to update this recommendation. The USPSTF uses the reaffirmation process for well-established, evidence-based standards of practice in current primary care practice for which only a very high level of evidence would justify a change in the grade of the recommendation.4 In its deliberation of the evidence, the USPSTF considers whether the new evidence is of sufficient strength and quality to change its previous conclusions about the evidence.
The USPSTF previously reviewed the evidence on serologic testing for HBV (hepatitis B surface antigen [HBsAg]) in pregnancy and found adequate evidence of its accuracy (sensitivity and specificity both >98%).
Benefits of Early Detection and Interventions
The USPSTF found convincing evidence that universal prenatal screening for HBV infection substantially reduces perinatal transmission of HBV and the subsequent development of chronic HBV infection. The USPSTF found adequate evidence that vaccination of all infants against HBV infection and providing postexposure prophylaxis with hepatitis B immune globulin (HBIG) at birth to infants of mothers infected with HBV substantially reduce the risk for acquisition of HBV infection in infants.
Harms of Screening and Interventions
The USPSTF found limited evidence on the harms of screening for HBV infection in pregnant women but bounded the potential harms of screening as no greater than small based on the high accuracy of screening and the low likelihood of harms from preventive interventions.
Using a reaffirmation process, the USPSTF concludes with high certainty that the net benefit of screening for HBV infection in pregnant women is substantial.
Patient Population Under Consideration
This recommendation applies to all pregnant persons.
The principal screening test for detecting maternal HBV infection is the serologic identification of HBsAg. Screening should be performed in each pregnancy, regardless of previous HBV vaccination or previous negative HBsAg test results.1
A test for HBsAg should be ordered at the first prenatal visit. Women with unknown HBsAg status or with new or continuing risk factors for HBV infection (eg, injection drug use or a sexually transmitted infection) should be screened at the time of admission to a hospital or other delivery setting.
Interventions to prevent perinatal transmission of HBV infection include screening all pregnant women for HBV, vaccinating infants born to HBV-negative mothers within 24 hours of birth, and completing the HBV vaccination series in infants by age 18 months. For HBV-positive mothers, case management during pregnancy includes HBV DNA viral load testing and referral to specialty care for counseling and medical management of HBV infection. For infants born to mothers who test positive for HBsAg, current guidelines for case management include HBV vaccination and hepatitis B immune globulin (HBIG) prophylaxis within 12 hours of birth, completing the vaccine series, and serologic testing for infection and immunity at age 9 to 12 months. For infants born to mothers with unknown HBsAg status, current guidelines for case management include HBV vaccination within 12 hours of birth, followed by HBIG prophylaxis.5
Emerging evidence has demonstrated that administering tenofovir to HBV-positive women with acute infection significantly reduces the risk of HBsAg seropositivity in infants when combined with HBIG prophylaxis at birth and HBV vaccination.6,7 As a result, recent guidelines recommend testing for viral load, antiviral treatment, and HBV vaccination and HBIG prophylaxis.5
The USPSTF has made recommendations on screening for other infections, including chlamydia and gonorrhea,8 HBV in nonpregnant adults and adolescents,9 genital herpes,10 HIV,11 and syphilis in pregnant women.12
Universal screening for HBV infection in women during pregnancy is standard clinical practice in the United States. Presently, 26 states have laws mandating prenatal HBV screening.15 Although rates of maternal screening for HBV infection range from 84% to 88%, screening rates during the first trimester are lower, with 60% of commercially insured and 39% of Medicaid-enrolled women screened during the first trimester.16 Seventy-one percent of infants receive HBV vaccination within 3 days of birth.1,17 Primary care clinicians and delivery settings must establish effective systems for the accurate and timely transfer of maternal HBsAg test results to labor, delivery, and newborn medical records to maximize benefit.1
Research Needs and Gaps
The USPSTF has identified areas of needed research. Continued research on effective implementation of case management in vulnerable populations most at risk for perinatal transmission of HBV infection is needed. Additional studies on the effectiveness of prenatal antiviral medication to reduce perinatal transmission are needed. Analyses of recent data from existing case management programs, such as the Perinatal Hepatitis B Prevention Program (PHBPP), would be helpful in understanding program performance and research needs.1 There is emerging evidence on the use of antiviral therapy during pregnancy.1,6,7 Further research is needed to examine the prevention of perinatal transmission.
Burden of Disease
Hepatitis B is a viral infection of the liver transmitted through contact with the bodily fluids or blood of an infected individual. In the United States, prevalence estimates of chronic HBV infection range from approximately 850,000 to more than 2 million cases.1,18-20 In the United States, new cases of HBV among adults are largely transmitted through injection drug use or sexual intercourse, but most prevalent cases of HBV infection are chronic infections from exposure occurring in infancy or childhood. Another major risk factor for HBV infection is country of origin. In the United States, adults with HBV born in high-prevalence countries were commonly infected during birth.19 In US-born children, the primary source of infection is vertical transmission at birth.21 According to the CDC, 800 to 1000 cases of perinatal transmission (3.8% of infants born to HBV-positive women) occurred yearly from 2000 to 2009.22
Since 1998, rates of maternal HBV infection have increased annually by 5.5%.1,2 Older maternal age, race/ethnicity (non-Hispanic black and Asian populations), lower education, higher poverty levels, and lack of insurance coverage are risk factors for HBV infection among women.2,23
Persons infected with HBV during infancy or childhood are more likely to develop chronic HBV infection and have poor long-term health outcomes (eg, chronic hepatitis, cirrhosis, or hepatocellular carcinoma) compared with persons infected later in life.1 Acute HBV infections progress to chronic disease in 80% to 90% of infected infants, 30% of acute infections progress before age 6 years, and less than 1% to 12% of acute infections progress in older children or adults. Approximately 25% of persons who become chronically infected during childhood and 15% of those infected as adults will die of cirrhosis or hepatocellular carcinoma.1,5,24
Scope of Review
To reaffirm its 2009 recommendation on screening for HBV infection in pregnant women, the USPSTF commissioned a reaffirmation evidence update. The aim of this update is to identify substantial new evidence sufficient enough to change the prior recommendation. Case management is the standard intervention in the United States for all HBV-positive pregnant women. As a result, the USPSTF targeted its evidence review to focus on the effectiveness and potential harms of screening and the effectiveness and harms of case management to prevent perinatal transmission.
Accuracy of Screening Tests
The primary screening test for detecting maternal HBV infection is the serologic detection of HBsAg. Serologic immunoassays for detecting HBsAg have a reported sensitivity and specificity greater than 98%.25,26
Effectiveness of Early Detection and Treatment
No studies were identified that directly assessed the benefits or harms of universal HBV screening during pregnancy. Two fair-quality observational studies reported perinatal transmission rates (primary outcome) over time.1,27,28
One study reported outcomes of case management from 1994 to 2008 for 155,081 infants born to HBV-positive women in the national PHBPP, administered by the CDC.1,27 From 1994 to 2008, the estimated number of infants born to HBV-positive women increased in the United States from 19,208 to 25,600 (P < .001). The proportion of infants born to HBV-positive women enrolled in the PHBPP for case management also increased during this period, from 42.1% to 47.9% (P = .002). The number of infants receiving case management increased from 7415 in 1994 to 12,033 in 2008 (P < .001).1,27
Perinatal transmission outcomes were reported for infants born from 1999 to 2008 who received serologic testing (n = 55,362). There was a statistically significant decrease in the perinatal transmission rate (P = .001). In 1999, 1.9% of infants who received serologic testing were infected with HBV; by 2008, the rate had decreased to 0.8% (P = .001).1,27
The second observational study was conducted in a large regional health care system in the United States (Kaiser Permanente Northern California).1,28 The case management program reported on 4446 infants born to HBV-positive women from 1997 to 2010. More than 97% of the infants received HBV vaccination and HBIG prophylaxis within 12 hours of birth. Overall rates of perinatal transmission were very low (0.75%), and a decreasing trend in perinatal transmission was reported (incidence rate ratio, 0.90 [95% CI, 0.82-1.00]).1,28
The results on historical trends from the observational studies are at risk of bias because of changes in case management program implementation, other interventions (eg, antiviral medication), cultural or secular changes (eg, universal vaccination), changes in reporting methods, and differences in data collection procedures.1
Potential Harms of Screening and Treatment
No studies were identified that reported the potential harms of universal HBV screening during pregnancy or case management. Screening has a low false-positive rate, and treatment is rarely harmful.1
Estimate of Magnitude of Net Benefit
The USPSTF considered the evidence using a reaffirmation process. The USPSTF previously found adequate evidence that serologic testing for HBsAg accurately identifies HBV infection. Interventions are effective for preventing perinatal transmission, based on foundational evidence and observational studies of US case management programs. In addition, there is evidence that over time, perinatal transmission has decreased among women and infants enrolled in case management, providing an overall substantial health benefit. Therefore, the USPSTF reaffirms its previous conclusion that there is convincing evidence that screening for HBV infection in pregnant women provides substantial benefit.
Response to Public Comment
A draft version of this recommendation statement was posted for public comment on the USPSTF website from January 8, 2019, to February 4, 2019. A majority of the comments wanted more information about treatment with antiviral therapy. In response, the USPSTF added information about emerging evidence that treatment with antiviral therapy works and that more research is needed in the Clinical Considerations and Research Needs and Gaps sections.
This recommendation is a reaffirmation of the USPSTF 2009 recommendation statement. In 2009, the USPSTF reviewed the evidence for screening for HBV infection in pregnant women and found that the benefits of screening substantially outweighed the harms.3 For the current recommendation, the USPSTF commissioned a targeted review to look for new and substantial evidence on the benefits and harms of screening and determined that the net benefit of screening for HBV infection in pregnant women continues to be well established. The USPSTF found no new substantial evidence that would change its recommendation and, therefore, reaffirms its recommendation to screen for HBV infection in pregnant women.
The American College of Obstetricians and Gynecologists recommends screening for HBV with serologic testing for HBsAg in every pregnant patient at the earliest prenatal visit. These tests should be designated as “prenatal.” Pregnant women who test positive for HBsAg should then be tested for HBV DNA.29 The CDC Advisory Committee on Immunization Practices similarly recommends testing for HBsAg in all pregnant women during an early prenatal visit (e.g., in the first trimester) and HBV DNA testing for pregnant women who test positive for HBsAg.5 The American Academy of Family Physicians recommends screening for HBV infection in pregnant women at their first prenatal visit.30 The American Association for the Study of Liver Diseases recommends screening in all pregnant women by testing for HBsAg and the hepatitis B surface antibody (anti-HBs).24
The US Preventive Services Task Force (USPSTF) members include the following individuals: Douglas K. Owens, MD, MS (Veterans Affairs Palo Alto Health Care System, Palo Alto, California, and Stanford University, Stanford, California); Karina W. Davidson, PhD, MASc (Feinstein Institutes for Medical Research at Northwell Health, Manhasset, New York); Alex H. Krist, MD, MPH (Fairfax Family Practice Residency, Fairfax, Virginia, and Virginia Commonwealth University, Richmond); Michael J. Barry, MD (Harvard Medical School, Boston, Massachusetts); Michael Cabana, MD, MA, MPH (University of California, San Francisco); Aaron B. Caughey, MD, PhD (Oregon Health & Science University, Portland); Chyke A. Doubeni, MD, MPH (Mayo Clinic, Rochester, MN); John W. Epling Jr, MD, MSEd (Virginia Tech Carilion School of Medicine, Roanoke); Alex R. Kemper, MD, MPH, MS (Nationwide Children’s Hospital, Columbus, Ohio); Martha Kubik, PhD, RN (Temple University, Philadelphia, Pennsylvania); C. Seth Landefeld, MD (University of Alabama at Birmingham); Carol M. Mangione, MD, MSPH (University of California, Los Angeles); Lori Pbert, PhD (University of Massachusetts Medical School, Worcester); Michael Silverstein, MD, MPH (Boston University, Boston, Massachusetts); Melissa A. Simon, MD, MPH (Northwestern University, Evanston, Illinois); Chien-Wen Tseng, MD, MPH, MSEE (University of Hawaii, Honolulu); John B. Wong, MD (Tufts University School of Medicine, Boston, Massachusetts).
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Authors followed the policy regarding conflicts of interest described at https://www.uspreventiveservicestaskforce.org/Page/Name/conflict-of-interest-disclosures. All members of the USPSTF receive travel reimbursement and an honorarium for participating in USPSTF meetings.
Funding/Support: The USPSTF is an independent, voluntary body. The US Congress mandates that the Agency for Healthcare Research and Quality (AHRQ) support the operations of the USPSTF.
Disclaimer: Recommendations made by the USPSTF are independent of the US government. They should not be construed as an official position of AHRQ or the US Department of Health and Human Services.
Copyright Notice: USPSTF recommendations are based on a rigorous review of existing peer-reviewed evidence and are intended to help primary care clinicians and patients decide together whether a preventive service is right for a patient's needs. To encourage widespread discussion, consideration, adoption, and implementation of USPSTF recommendations, AHRQ permits members of the public to reproduce, redistribute, publicly display, and incorporate USPSTF work into other materials provided that it is reproduced without any changes to the work of portions thereof, except as permitted as fair use under the US Copyright Act.
AHRQ and the US Department of Health and Human Services cannot endorse, or appear to endorse, derivative or excerpted materials, and they cannot be held liable for the content or use of adapted products that are incorporated on other Web sites. Any adaptations of these electronic documents and resources must include a disclaimer to this effect. Advertising or implied endorsement for any commercial products or services is strictly prohibited.
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