SAN FRANCISCO -- Universal screening of pregnant women at risk for hepatitis C virus (HCV) infection was a more efficient and cost-effective diagnostic approach than risk-based screening, researchers said here.
In a sample of nearly 20,000 pregnant women, universal screening was associated with an increased odds of a patient demonstrating a positive RNA result (OR 1.8, 95% CI 1.5-2.3, P<0.001) and confirmed active infection (OR 2.1, 95% CI 1.4-3.0, P<0.001). However, universal screening did not increase the likelihood of a positive HCV antibody test compared with a risk-based approach (odds ratio 1.1, 95% CI 0.9-1.4, P=0.346), reported Michelle Rose, MBA, of Norton Healthcare in Louisville, Kentucky, and colleagues.
They also found that universal screening was more cost-effective than risk-based screening in this population, with universal screening demonstrating an incremental cost-effectiveness ratio of $2,905, which is "well below the willingness-to-pay threshold" set at $100,000 per quality adjusted life year gained, Rose told ѻý.
"Risk-based antibody screening alone missed a significant number of pregnant women not being correctly identified with active infection and thus not being able to link them to care," Rose said during a presentation at the annual Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD). "Universal screening seems to cost-effectively increase the likelihood that infected pregnant women were identified and therefore can be linked to care and treated."
Rose said that including the reflex RNA PCR portion of this test during a patient's initial screening could reduce the chance of false-positive antibody tests, and could expedite how quickly patients are referred to treatment. "By streamlining the testing and diagnostic process and universally screening, what we found is that it actually shortened the time by which a patient knows their [HCV] and could be linked to proper care," Rose told ѻý.
Jordan Feld, MD, MPH, of the Toronto Western Hospital Liver Center, said faster linkage to care could prevent the disease from spreading and that it may provide a platform on which providers and patients can more easily discuss existing risk factors that may have before gone unnoticed.
"Even if you can't treat people, there are really important benefits for linking people to medical care, and treating them before their next delivery," he said. "I think it's a really good opportunity to engage them in harm reduction around their injection drug use."
Overall, 19,453 women, ages 13-52, were included in the analysis. All were cared for at Norton Healthcare in Louisville. The state of Kentucky is at the epicenter of the opioid crisis, and saw an increased HCV detection rate in young women nearly 10 times higher than the general U.S., Rose reported.
Because of the increase of at-risk patients, Rose said the Norton Healthcare implemented a universal screening policy for at-risk pregnant women in 2016. This study collected data from 10,420 pregnant women in a retrospective analysis of the risk-based approach used at the healthcare system from May 1, 2014 to Dec 31, 2015. and 9,033 women in a prospective analysis of the universal approach with reflex RNA PCR used from May 1, 2016 to Dec. 31, 2017.
The authors tested the proportion of positive screen and confirmatory tests performed across these two periods, and found that when moving from risk-based to universal screening, the seropositivity rates increased from 4.3% to 4.9%. This meant that during the center's risk-based period, a significant number of women were missed, Rose said.
Feld said this uptick was "striking," as moving to a wider screening population would typically decrease positivity rates. He said this trend could be attributed to the failure to identify patients as at risk, or to a significant increase in the population's risk over the 2 years. Either way, this difference means that only a fraction of patients who are actually at risk were detected with risk-based screening, he said.
AASLD announced that recommend "all pregnant women be tested for HCV infection, ideally at the start of their prenatal care." These , created in collaboration with the Infectious Diseases Society of America (IDSA), state that universal screening would increase opportunities for education and referral and allow for earlier treatment. Ultimately, it would "improve the health of women" and "prevent future HCV transmission."
Rose said that she would like to see additional studies that compare different methods of linking subpopulations to care in order to determine how these women may be best guided towards treatment, and how to have the largest impact on eliminating HCV.
Rose also noted that a proposed bill in the Kentucky legislature () recommends testing for children born from a pregnant woman who has a positive HCV test result.
"Therefore, we are working on screening and linkage to care strategies for infants and children exposed to HCV via prenatal and household transmission, as well as linkage to care strategies for women identified as HCV positive during pregnancy," Rose said in an AASLD .
Disclosures
Rose disclosed support from Gilead Sciences.
Primary Source
American Association for the Study of Liver Diseases
Rose M, et al "Hepatitis C Virus Risk-Based Vs. Universal Screening Among Pregnant Women: Implementation and Cost-Effectiveness Analysis)" AASLD 2018; Abstract 0087.