United States Preventive Services Task Force
5600 Fishers Lane, #06E53A
Rockville, Maryland 20857
National Center for Health Research’s Public Comment on USPSTF Draft Research Plan for Human Immunodeficiency Virus (HIV) Infection in Pregnant Women: Screening
Thank you for the opportunity to express our views on the draft research plan for HIV infection screening for pregnant women. This is a very important issue for the health of pregnant women and their children.
The National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and health experts who analyze and review research on a range of health issues.
While USPSTF’s past reviews determined that there was a net benefit of screening for HIV infection in pregnant women, there were gaps in the literature, and subsequent treatment regimens require evaluation. We appreciate USPSTFs efforts to keep up with evolving research by regularly reevaluating the literature and reviewing the recommendations, extracting as much moderate-to-high quality data from the literature as possible.
The USPSTF recommendations will be most useful to patients if they are based on studies that accurately represent the population that needs screening, i.e. all pregnant women. Therefore, the draft research plan should endeavor to ensure that there are subgroup analyses of all major groups of women, rather than using exclusion criteria that may unintentionally introduce bias. Excluding women with “occupational exposure” would exclude women who need effective screening and could also disproportionately exclude some demographic groups. Furthermore, the final research plan should include a clear definition of the term “occupational exposure,” in order to minimize confusion over studies to include.
Long-term studies are needed to elucidate the potential benefits and harms of treatment in adults and their children. Hence, it is important to include as many quality long-term follow-up studies as possible that appropriately study the effects of these drugs for women, and to the children born to women taking these drugs. Although the previous recommendation found that the health risks of taking antiretroviral drugs were small compared to the health risks of untreated HIV infection, it is still necessary to know what the health risks may be. There may be few long-term studies that look at health risks for these populations. Therefore, we are concerned that ambiguous inclusion/exclusion criteria could unintentionally overlook some of these studies. In addition, interpreting potential harms broadly for both mothers and children ensure the identification of known risks and allow better consideration of risks in the updated recommendation.
One of the key questions aims to find studies to understand the benefits and harms of antiretroviral treatment for the fetus and pregnant mother. The draft review plan currently excludes studies of women with known HIV infection. The problem is that limiting these studies to only those that included screening of asymptomatic pregnant women and initiation of treatment during pregnancy might result in very few studies that can be included. While the recommendation may focus on women of unknown HIV status and thus start treatment during pregnancy, it is possible that many of the potential harms caused by treatment will be similar between women of known and unknown HIV status.
We strongly support USPSTF’s ongoing effort to provide screening guidances based on quality, up-to-date scientific studies. We recommend a very careful selection of exclusion populations and studies in order to have a thorough review that allows the USPSTF to develop the most informed recommendations possible.
For questions or more information, please contact Stephanie Fox-Rawlings at sfr@center4research.org.
Reference:
USPSTF Final Recommendation Statement Human Immunodeficiency Virus (HIV) Infection: Screening, April 2013.
USPSTF Draft Research Plan Draft Research Plan for Human Immunodeficiency Virus (HIV) Infection in Pregnant Women: Screening, February 2017.