Thank you for the opportunity to express our views on the draft research plan regarding screening for the Hepatitis B virus infection in pregnant women. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
Hepatitis B is a virus infection that is best prevented through vaccination. The risk of infection is especially high for newborns; 90% of infected infants become chronically infected. Chronic Hepatitis B can lead to serious health issues, such as cirrhosis or liver cancer, and in the United States, results in an estimated 1,800 deaths per year. Detecting Hepatitis B infection in pregnant women and preventing transmission to their children would benefit our society greatly by decreasing its disease burden.
Women who are pregnant are at a unique moment in their health care journey, during which they have multiple visits with a provider. Ideally, strong and trusting relationships will develop between women and their doctors. Thus, the capacity for women to acquire knowledge and respond to information regarding screening and potential immunization is greater during pregnancy than at other times and with other providers. This can lead to positive public health outcomes.
The U.S. Preventive Services Task Force (USPSTF) last reviewed the literature in 2009 and reaffirmed their “A” grade for HBV screening for women at their first prenatal visit. We support the efforts of the USPSTF to carefully draft a research plan to guide the systematic review of available evidence for universal screening and case management programs to prevent vertical transmission of the infection as well as reduced rates of morbidity and mortality. We also endorse the efforts of the USPSTF to obtain updated information on the harms and benefits of universal screenings and case management programs for women with Hepatitis B.
We have two recommendations regarding key and contextual questions:
1) While the proposed research questions may intend to refer to both the mother and child, they do not explicitly state the benefits and harms of maternal screening and subsequent immunization or administration of HBIG for children. We believe that explicitly including harms and benefits to children in utero within your proposed questions will improve your research plan.
2) We commend the USPSTF’s inclusion of proposed contextual question #1 to address subgroup analyses. We particularly recommend subgroup analyses by race/ethnicity, mothers’ age, and mothers’ health. Some subgroups of pregnant women may experience different levels of benefits/harms, and this information is critical in making a recommendation for all women. In addition to benefits, we recommend including any harms of repeat screening in the third trimester based on the presence of specific risk factors for different groups of pregnant women.
Universal screening and prevention programs for pregnant women with Hepatitis B can help to identify pregnant women who are at risk for passing the virus to their children. Preventing vertical transmission protects children from a potentially serious disease and other diseases that may develop as a result, such as cancer; protects others who may be infected; and allows children to participate in school and play activities important to their healthy development. Therefore, screening is highly beneficial for these children.
In conclusion, we support the USPSTF’s draft recommendation for Hepatitis B screening in pregnant women as well as their broader efforts to improve the health of all Americans by making evidence-based recommendations about clinical preventive services.
For questions or more information, please contact Megan Polanin, PhD at mp@center4research.org or at (202) 223-4000.
References
Centers for Disease Control and Prevention (2015, May 31). Viral Hepatitis. Retrieved from https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm#overview
U.S. Preventive Services Task Force (2017, July). Draft Research Plan for Hepatitis B Virus Infection in Pregnant Women. Retrieved from https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/hepatitis-b-virus-infection-in-pregnant-women-screening