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Prevention of Vertical Transmission of Hepatitis B: An Observational StudyPrevention of Vertical Transmission of Hepatitis B

Ai Kubo, PhD*; Lyle Shlager, MD*; Amy R. Marks, MPH; Dena Lakritz, RN, MPH; Colette Beaumont, RN, MSN; Kim Gabellini, RN, MS; and Douglas A. Corley, MD, PhD
[+] Article, Author, and Disclosure Information

* Drs. Kubo and Shlager are lead coauthors of this article.

This article was published online first at www.annals.org on 27 May 2014.

From Kaiser Permanente Division of Research and Oakland Medical Center, Oakland, and Kaiser Permanente San Francisco Medical Center, San Francisco, California.

Disclaimer: The content of this publication does not necessarily reflect the views or policies of the National Institutes of Health, and the mention of trade names, commercial products, or organizations does not necessarily imply endorsement by the U.S. government. The authors assume full responsibility for the accuracy and completeness of the ideas presented.

Financial Support: By the Kaiser Permanente Community Benefit (grant CN-09LShla-01-H). Dr. Kubo is also supported by the National Cancer Institute and the National Institutes of Health Office of Research on Women's Health (career development award K07CA166143-01A1) and the National Center for Advancing Translational Sciences of the National Institutes of Health (KL2TR000143).

Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-2529.

Reproducible Research Statement: Study protocol: Available from Dr. Kubo (e-mail, ai.kubo@kp.org). Statistical code and data set: Not available.

Requests for Single Reprints: Ai Kubo, PhD, Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612; e-mail, ai.kubo@kp.org.

Current Author Addresses: Drs. Kubo and Corley and Ms. Marks: Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA 94612.

Dr. Shlager: Kaiser Permanente San Francisco Medical Center, 2350 Geary Boulevard, San Francisco, CA 94115.

Ms. Lakritz, Ms. Beaumont, and Ms. Gabellini: Kaiser Permanente Oakland Medical Center, 3505 Broadway, Oakland, CA 94611.

Author Contributions: Conception and design: A. Kubo, L. Shlager, D. Lakritz, D.A. Corley.

Analysis and interpretation of the data: A. Kubo, L. Shlager, A.R. Marks, D. Lakritz, C. Beaumont, K. Gabellini, D.A. Corley.

Drafting of the article: A. Kubo, L. Shlager, A.R. Marks, D. Lakritz, D.A. Corley.

Critical revision of the article for important intellectual content: A. Kubo, L. Shlager, A.R. Marks, D. Lakritz, K. Gabellini, D.A. Corley.

Final approval of the article: A. Kubo, L. Shlager, D. Lakritz, K. Gabellini, D.A. Corley,

Provision of study materials or patients: C. Beaumont.

Statistical expertise: A.R. Marks, D.A. Corley.

Obtaining of funding: A. Kubo, L. Shlager, D.A. Corley.

Administrative, technical, or logistic support: A.R. Marks, D. Lakritz, K. Gabellini.

Collection and assembly of data: A. Kubo, A.R. Marks, D. Lakritz, C. Beaumont, K. Gabellini, D.A. Corley.

Ann Intern Med. 2014;160(12):828-835. doi:10.7326/M13-2529
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Background: For mothers with chronic hepatitis B virus (HBV) infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice.

Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol.

Design: Observational study.

Setting: An HBV perinatal immunoprophylaxis program within Kaiser Permanente Northern California.

Patients: 4446 infants born to 3253 HBV-positive mothers between 1997 and 2010.

Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors for HBV transmission, and transmission rates.

Results: The infant infection rate was 0.75 per 100 births from 1997 to 2010 (Poisson 95% CI, 0.48 to 1.10). Rates per 100 births were 3.37 (CI, 2.08 to 5.14) for e antigen–positive mothers and 0.04 (CI, 0.001 to 0.24) for e antigen–negative mothers. Among mothers with viral load testing, the lowest level associated with transmission was 6.32 × 107 IU/mL. Infection rates per 100 births were 3.61 (CI, 0.75 to 10.56) among the 83 births to mothers with viral loads of 5 × 107 IU/mL or greater and 0 among the 831 births to mothers with viral loads less than 5 × 107 IU/mL, regardless of e antigen status.

Limitations: Testing for HBV immunity and infection was less complete in earlier years. Viral load testing was only consistently available starting in 2007.

Conclusion: Prenatal HBV screening followed by postnatal prophylaxis is highly effective in preventing vertical transmission of HBV. A negative e antigen status or a viral load less than 5 × 107 IU/mL (90.9% of women tested) identifies women at extremely low risk for transmission after immunoprophylaxis who are unlikely to benefit from further interventions.

Primary Funding Source: Kaiser Permanente Community Benefit and National Institutes of Health.


Grahic Jump Location
Figure 1.

Proportion of infants receiving HBIg within 12 h after birth plus 3 hepatitis B vaccines within 7, 8, and 12 mo, 1997–2010.

An individual hepatitis B vaccination may or may not have been on time. In 2001, the program coordinators began calling the infants’ providers before the 6-mo appointment to remind them to administer the final vaccine and postvaccination serologic tests. This policy probably caused the increase in the proportion of infants who received HBIg and all 3 vaccine doses by month 7 between 2001 and 2003. HBIg = hepatitis B immunoglobulin.

Grahic Jump Location
Grahic Jump Location
Figure 2.

HBV-positive rate among all children tested (= 3353) and by maternal e antigen testing status (624 positive and 2317 negative).

HBsAg = hepatitis B surface antigen.

Grahic Jump Location




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