SAN FRANCISCO – Universal screening tests for pregnant women at risk for hepatitis C virus (HCV) infection are a more efficient and cost-effective diagnostic approach compared to risk-based screening, the researchers said here.
In a sample of nearly 20,000 pregnant women, universal screening was associated with an increased likelihood of patients showing positive RNA results (OR 1.8, 95% CI 1.5-2.3, P<0.001) and confirmed the 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 to a risk-based approach (odds ratio 1.1, 95% CI 0.9-1.4, P= 0.346), reported Michelle Rose, MBA, from 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 showing an additional cost-effectiveness ratio of $ 2,905, which was "well below the willingness-to-pay threshold" set at $ 100,000 per quality adjusted life years earned, Rose said MedPage Today.
"Risk-based antibody screening alone loses a large number of pregnant women who are not correctly identified with active infections and thus cannot connect them to treatment," Rose said during a presentation at the annual Heart Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD ) "Universal screening seems to effectively increase the likelihood that infected pregnant women are identified and can therefore be associated with care and treatment."
Rose said that including the reflex part of RNA PCR from this test during initial screening of patients can reduce the possibility of false positive antibody tests, and can accelerate how quickly patients are referred to treatment. "By simplifying testing and universal diagnostic and screening processes, what we found is that it really shortens the time that patients know [HCV] and can be associated with proper care, "Rose said MedPage Today.
Jordan Feld, MD, MPH, from the Toronto West Heart Hospital Center, said a faster relationship with care could prevent the spread of the disease and that it could provide a platform where providers and patients could more easily discuss existing risk factors that were possible before go unnoticed.
"Even if you can't take care of people, there are very important benefits to connecting people with medical care, and treating them before the next shipment," he said. "I think this is a very good opportunity to involve them in reducing their harm to injecting drug use."
Overall, 19,453 women, ages 13-52, were included in the analysis. All were treated at Norton Healthcare in Louisville. The state of Kentucky is in the epicenter of the opioid crisis, and sees increased HCV detection rates in young women almost 10 times higher than the general US, Rose reported.
Because of the increase in risky patients, Rose said Norton Healthcare implemented a universal screening policy for risky pregnant women in 2016. The study collected data from 10,420 pregnant women in a retrospective analysis of the risk-based approach used in the health system from 1 May 2014 to 31 December 2015. and 9,033 women in a prospective analysis of a universal approach with RNA PCR reflexes were used from 1 May 2016 to 31 December 2017.
The authors examined the proportion of positive screens and confirmatory tests carried out during these two periods, and found that when moving from risk-based to universal screening, seropositive rates increased from 4.3% to 4.9%. This means that during a period of center-based risk, a large number of women are missed, Rose said.
Feld said this uptick was "surprising," because moving to a wider screening population would usually lower the positive level. He said this trend could be attributed to failure to identify patients as risky, or a significant increase in population risk for 2 years. Either way, this difference means that only a small percentage of patients are really at risk of being detected by risk-based screening, he said.
AASLD announces the latest guidelines that recommend "all pregnant women be tested for HCV infection, ideally at the start of their prenatal care." This HCV guideline, made in collaboration with the Infectious Diseases Society of America (IDSA), states that universal screening will increase opportunities for education and referral and allow for earlier treatment. In the end, it will "improve women's health" and "prevent the transmission of HCV in the future."
Rose said she wanted to see additional studies comparing various methods linking subpopulations with treatments to determine how these women could be well guided in treatment, and how to have the greatest impact on HCV removal.
Rose also noted that the bill proposed in the Kentucky parliament (SB250) recommended testing for children born to pregnant women who had positive HCV test results.
"Therefore, we are conducting screening and linkages to care strategies for infants and children exposed to HCV through prenatal and household transmission, as well as linkages to treatment strategies for women identified as HCV positive during pregnancy," Rose said in a broadcast AASLD press.
Rose expressed support from Gilead Sciences.
2018-11-1100: 00: 00-0500