Adherence to Pregnancy Hepatitis B Care Guidelines in Women and Infants in the United States and Evaluation of Two Interventions to Improve Care

A Multicentre Hospital-based Study

Tatyana Kushner; Elianna Kaplowitz; Rena Mei; Chelsea Xu; Alex Acker; Emma Rosenbluth; Igbagbosanmi Oredein; Monika Sarkar; Norah Terrault; Meena Bansal; Kimberly A. Forde


J Viral Hepat. 2021;28(4):582-591. 

In This Article


We performed a U.S. multicentre health system updated assessment of adherence to hepatitis B care guidelines in women during pregnancy and their infants, at a time with increased focus by the WHO and Centers for Disease Control and Prevention (CDC) on HBV elimination. In our study, for 33% of patients, the pregnancy encounter was the first time for HBV diagnosis, highlighting the importance of pregnancy as an opportunity for HBV linkage to care. Although we found that adherence to maternal standard of care measures for hepatitis B during pregnancy was suboptimal, we saw improvement over time and particularly with interventions such as co-location of care in the obstetrics unit. In addition, almost 20% of infants did not receive all vaccine doses and PVST. These gaps may reflect limited awareness of HBV guidelines at the provider level, nonadherence by patients due to low importance placed on HBV care during pregnancy, inadequate cross-disciplinary communication between obstetricians and HBV specialists, and/or inadequate recording of vaccine completion. Minority mothers and infants of mothers with government (as opposed to private) insurance, generally considered underserved populations in the United States, were more likely to receive the standard of care. We theorize that providers, as well as programs to improve outcomes, may selectively apply increased vigilance to certain 'high-risk' groups, or those that are viewed as more 'likely' to have HBV infection, leaving others susceptible to gaps in care.

Our study adds to the growing body of evidence showing that the appropriate surveillance of mothers during and after pregnancy does not always occur, reflecting a critical gap in care with potential downstream repercussions to HBV disease outcomes. The American Congress of Obstetricians and Gynecologists (ACOG), CDC, and AASLD recommend that women who are diagnosed with HBV in the peripartum stage be referred to a provider experienced in the management of chronic hepatitis B, in order to receive appropriate follow-up for liver disease monitoring, hepatocellular carcinoma (HCC) surveillance, and need for AVT.[8,18,19] Yet, a study within one large academic centre found that 49% never had specialist follow-up.[11] Another study using commercial insurance claims across the United States revealed that 58% of pregnancies with an associated HBV diagnosis code were not linked to appropriate HBV care during pregnancy or postpartum.[20] In a review of ICD-9 codes using the Optum national database, only 21% of women with peripartum HBV had maternal specialist follow-up rates.[14] Those who were referred to a specialist were the most likely to receive appropriate laboratory testing, similar to what we describe.[14] Although we had higher rates of specialist referral in our study (62%), it is clear that lack of a formal referral system contributes to discontinuity of care, representing an area of potential intervention.[13] Co-location of care, as we describe, although potentially resource heavy, may be needed to increase HBV specialist referral (Figure 2a/b) for management during pregnancy and linkage post-delivery.

Appropriate laboratory testing and antiviral therapy are also integral parts of HBV management in pregnancy, and prior United States-based studies have also demonstrated gaps. In a single state surveillance database from the Massachusetts Department of Public Health, only half of HBsAg-positive women received recommended HBV laboratory follow-up.[10] Similarly, a study spanning five Perinatal Hepatitis B Prevention Programs showed that although 80% of HBsAg-positive women were screened before delivery, only 20% received additional testing and 36% received HBV treatment.[21] A survey of provider practices found that suboptimal knowledge about HBV infection and interpretation of serologies contributed to inadequate care, representing an area of potential intervention.[13] Thus interventions targeted towards improving HBV knowledge, particularly in low endemic settings such as the United States, have huge potential to improve care provided. Although clinical decision support in our study did not demonstrate a meaningful change, perhaps BPAs with more educational content can be implemented to guide providers on appropriate laboratory testing and antiviral therapy initiation.

Regarding infant follow-up, in 1991, the Advisory Committee on Immunization Practices (ACIP) recommended administration of a 3-dose vaccination series at 0, 1–2 and 6–18 months old to all infants as part of a focused strategy to eradicate HBV transmission as well as HBIG within 12 hours of birth to infants born to mothers with HBV.[22] Despite this strong national effort to eradicate transmission through vaccination, the National Immunization Survey (NIS) estimated that only 75.0% of children born from 2015 to 2016 received the birth dose of the hepatitis B vaccine[23] and that 91.0% received 3 or more doses by 24 months old.[24] Among the states of institutions in our study, 91.4% of 2-year-old children living in New York state, 91.6% in Pennsylvania and 90.9% in California who participated in the NIS received 3 or more doses of the hepatitis B vaccine.[25,26] Although our study found that over 90% received HBIG and the first dose of the HBV vaccine, there was significant drop-off for the 2nd and 3rd vaccine doses—suggesting these as areas for future health system–based interventions to improve vaccine completion rates, at appropriate time intervals. In addition, our findings highlight that the NIS may not be capturing certain populations with lower vaccine rates.

Although current efforts to eradicate HBV may be proportional to HBV prevalence, it is important to recognize that interventions in low endemic countries such as the United States are still necessary for global eradication of HBV. Capitalizing on the EHRs in health systems, clinical decision support may be used to improve adherence, although as demonstrated by our study, may not be sufficient to improve overall care delivery. On the other hand, co-locating care, and therefore increasing interaction and patient care management plans between obstetricians and HBV specialists, may not only improve care delivered during pregnancy, but may also improve linkage to care for future maternal and infant health. As demonstrated in other liver disease and obstetrics contexts,[27–30] care co-location improves disease outcomes, and may take the form of co-located established clinic, visiting provider in the obstetrics context, or pregnancy clinic held within the liver diseases practice. The ultimate goal of these types of practices is to reduce variance and outliers in care, so that care is uniformly provided to all patients (regardless of insurance, demographics or health history), and value-based care models are integrated into practices across the country.[31] Interestingly, we found that screening and linkage to care were better for traditionally underserved populations indicating that attention to care delivery in these populations is effective. We must understand barriers that may be relevant to all populations in order to address, adjust and improve.

There are a few limitations to our study. Given its retrospective design and reliance on EHR review, data inadequately recorded by providers may have been missed. Furthermore, if mothers or infants received follow-up outside of the health systems studied, their data may not have been complete, although we did use citywide vaccine registries (in addition to hospital records) to obtain immunization history. As a result, there could have been misclassification bias for women not receiving specialist referral or appropriate bloodwork and/or infants being recorded as not having received appropriate vaccine/HBIG doses (when in fact they may have received them in another health system). In addition, our study was performed at three large tertiary care centres with expertise in management of liver diseases in the United States—results cannot be generalized to other health settings such as community hospitals and/or health settings out of the United States, where practices may be significantly different. Nonetheless, to our knowledge, this is the largest United States EHR-based assessments of HBV pregnancy care practices, with a comprehensive assessment of both the maternal and infant cascade of care, across three distinct healthcare settings.

In summary, we found that rates of adherence to care guidelines for HBV for mothers during pregnancy and their infants are suboptimal but appear to be improving over time. Interventions such as co-location of care with HBV specialists and obstetricians are important in order to improved care follow-up, as well as infant vaccination programs that do not only focus on 'high-risk' patient populations. More broadly mandated hospital-based programs in order to maximize effective systems for HBV care management during pregnancy are needed to optimize HBV care, eliminating variance across healthcare settings, ultimately to work towards the goal of HBV elimination in the United States