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

Disclosures

J Viral Hepat. 2021;28(4):582-591. 

In This Article

Results

A total of 372 patients with 404 live births had complete data; of the 32 women with multiple pregnancies during this time period, only their first reported pregnancy was included for analysis (N = 372). Patients had a mean age of 32.5 years and were mostly of Asian (49%) or Black (36%) race (Table 1). One hundred seventy-four (47%) had a reported a country of origin from outside of the US (Table S2). Around half (55%) had private health insurance (Table 1).

Hepatitis B Characteristics

A new diagnosis of HBV was made in pregnancy in 112 (33%) of pregnancies (Table 1). Most women were HBeAg-negative (83%) with HBV DNA ≤2000 IU/mL (65%) and maximum ALT ≤25 (66%). Only 46 (15%) had HBV DNA ≥200,000. Sixty-five (18%) had received antiviral therapy prior to pregnancy. No patients had cirrhosis or decompensated liver disease.

Adherence to Maternal Care Measures

We analysed adherence to each of the predefined care measures (Figure 1).

Figure 1.

Adherence to care measures among pregnant women positive for HBV. Bar height corresponds to the number of patients who met criteria for each of the three care measures (Specialty Referral = 266, HBV DNA Testing = 372, AVT Initiation = 34 for HBV DNA ≥ 200 K and 11 for HBV DNA ≥ 2 K and ALT ≥ 50, All Care Measures = 372). Blue colour and percentages refer to the number of patients who successfully completed these care measures out of the patients who met criteria to complete them, red colour refers to those who did not complete these care measures. *Met adherence to care measures refers to patients who completed all care measures for which they met criteria out of the following three care measures: 1. Referral to liver Specialist, 2. HBV DNA checked in 3rd trimester and 3. AVT started when HBV DNA ≥200,000

HBV Specialist Referral. Among the women in our cohort, 106 (29%) were already being seen by an HBV specialist prior to pregnancy. If not previously seen by a specialist, 62% of patients were referred to an HBV specialist and 87% of those who were referred attended their visit. Of note, 97% of women being seen by a specialist compared to 75% women without a specialist had liver tests checked; among those with an ultrasound ordered, 84% under specialist care had an ultrasound performed compared to 62% without specialist care.

HBV Viral Load Testing. Eighty-five per cent of patients had HBV DNA checked during pregnancy, but only 51% had HBV DNA assessed at the recommended time. HBV DNA results are shown in Table 1.

Initiation of Antiviral Therapy. Sixty-eight per cent of patients with HBV DNA ≥200,000 were initiated on antiviral therapy. All patients were treated with tenofovir disoproxil fumarate (TDF). Only 9 (2%) patients ever met the standard treatment criteria of HBV DNA ≥2000 and ALT ≥50, and 5 (55%) of these patients were started on antiviral therapy.

Factors Associated With Maternal Care. We evaluated factors associated with the composite maternal outcome (see Table S3). In unadjusted analysis, maternal age ≤35, non-white race, normal BMI and provider type ordering the HBsAg screening test were associated with completing all care measures for which the patient met criteria. In adjusted analysis, women ≥35 years of age (OR 0.6, 95% CI: 0.3–0.9) and overweight/obese patients (OR 0.5, 95% CI: 0.3–0.9) remained less likely to complete all measures of care (Table 2).

Evaluation of Interventions to Improved Adherence to Maternal Care Measures. Initiation of a co-located liver diseases clinic in both the Mount Sinai Health System and the University of Pennsylvania Health System appeared to significantly improve adherence to maternal care measures at both sites (Figure 2a and b). Implementation of a best practice alert (BPA) in the EHR in order to remind care providers to initiate antiviral therapy for women with HBV DNA >200,000 did not demonstrate a significant change in adherence to the key measure. Despite BPA implementation, the BPA did not alert for all appropriate patients, and adherence to this care measure was already at 100% before BPA implementation. When evaluating data over time, there appeared to be an improvement in adherence to all care measures, though available data in some months/quarters were sparse (Figure S1).

Figure 2.

a. Adherence to care measures among pregnant women positive for HBV at Mount Sinai Health System before and after a Specialized Liver Center was opened. Numbers at the base of each bar refer to the number of patients that met criteria for each care measure. Bar height corresponds to the proportion of patients who completed each care measure if eligible. +No patients at MSE/MSW were eligible for AVT initiation based on HBV DNA ≥2 K & ALT ≥50 after the liver centre was opened. *Statistically significant difference in proportion of women meeting care measure before and after liver centre initiation. b. Adherence to Care Measures among Pregnant Women Positive for HBV at University of Pennsylvania Health System (UPHS) before and after a Specialized Liver Center was opened there in October 2015. This figure utilizes additional data than the 372 births in the main data set 216 patients from a previous data set from UPHS was added to the main data set to increase the number of births before October 2015. Numbers at the base of each bar refer to the number of patients that met criteria for each care measure. Bar height corresponds to the proportion of patients who completed each care measure if eligible. *Statistically significant difference in proportion of women meeting care measure before and after liver centre initiation

Adherence to Infant Care Measures

Infant vaccine follow-up data were available from two sites and for 136 of the mothers' included in the study. Although all 136 infants received HBIG, 123 (91%) received it within 12 hours of birth. All received the first HBV vaccine dose, 106 (81%) received the second, 94 (74%) received the 3rd HBV vaccine dose, with 123 (91%), 102 (78%) and 62 (49%), respectively, at the correct time intervals (Figure 3). Among those who received paediatric care in the same hospital system as delivery, 50 (83%) had PVST with 34 (57%) receiving PVST at 9–12 months; 25 (42%) with PVST had HBsAb titre checked, and all had HBsAb ≥ 10 IU/mL. In unadjusted analyses, children of mothers of Asian race (OR 0.3, 95% CI: 0.1–0.9) or of advanced maternal age (≥35 years) (OR 0.1, 95% CI: 0.0–0.8) were less likely to complete all care measures; children of mothers with public health insurance (Medicaid, Medicare, other) (OR 4.8, 95% CI: 1.3–17.2) were more likely to receive all care measures on time (Table 3).

Figure 3.

Adherence to baby vaccination care measures among pregnant women positive for HBV. Bar height corresponds to the number of babies who met criteria for each vaccine or PVST. Blue colour and percentages refer to the number of babies who successfully completed these care measures out of those who met criteria to complete them; red colour refers to those who did not complete these care measures.

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