There are as many as 4 million people in the United States living with hepatitis C virus (HCV) infection, according to the Centers for Disease Control and Prevention. Physicians often evaluate the effects of HCV infection on the liver by staging, or using tests to describe the progression of liver damage. However, there are no current guidelines that agree on one non-invasive test for liver disease staging, and some insurers and practices require staging prior to receiving treatment.
STUDY OBJECTIVE
Researchers set out to compare different non-invasive strategies for liver disease staging in patients with chronic HCV infection. They compared the Fibrosis-4 index (FIB-4), which estimates the amount of scarring in the liver and the likelihood of advanced liver fibrosis using laboratory tests, and transient elastography (TE, i.e. FibroScan®), which measures liver stiffness using an ultrasound.
DETAILS
The team used a simulation model of 10 million adults with chronic HCV receiving care at health centers across the United States to examine the clinical benefits, risks, and cost-effectiveness of fibrosis staging using FIB-4, TE, and a combination of the two methods.
FINDINGS
The researchers found that if a patient already had laboratory tests done prior to their HCV treatment evaluation or could complete them that day, calculating FIB-4 alone provided the best clinical outcomes at a lower cost for patients than performing TE, unless TE could be completed in-office the same day. In scenarios where no prior laboratory tests were available, proceeding with treatment without liver disease staging led to improved clinical outcomes. This was due to loss to follow-up for patients who had a staging test ordered first.
IMPACT
“Many clinicians worry that if they skip liver disease staging, they could miss a patient who has advanced liver disease and lose an opportunity to prevent liver cancer. This project demonstrates for clinicians, insurers, and guideline committees that connecting people to HCV treatment as quickly as possible - minimizing the chances that they are lost to follow-up and go untreated - is more important than getting perfect information about the degree of liver damage they have prior to treatment. If we work to treat people the same day that we diagnose them, we could streamline care and make treatment more accessible. This should improve both outcomes for patients and progress towards the national effort to eliminate HCV,” says Rachel Epstein, MD, MScE, first author on the paper, infectious disease clinician-scientist at BMC, and Assistant Professor of Medicine and Pediatrics at Boston University Chobanian & Avedisian School of Medicine.
Source: Epstein, R.L.; Munroe, S.; Taylor, L.E.; Duryea, P.R.; Buzzee, B.; Pramanick, T.; Feld, J.J.; Baptiste, D.; Carroll, M.; Castera, L.; Sterline, R.K.l; Thomas, A.; Chan, P.A.; and Linas, B.P. (2024) “Clinical- and Cost-Effectiveness of Liver Disease Staging." Clinical Infectious Disease.