Investigators formulated a five-factor metric known as the BE3A score that offers specialists a shared decision-making tool to predict potential improvements after treatment in patients with hepatitis C virus (HCV)-associated liver failure, as detailed in a new study published in Gastroenterology.
The five factors in the BE3A score include body mass index (BMI), encephalopathy, ascites, and serum levels of both alanine aminotransferase (ALT) and albumin.
“HCV infection can be successfully treated in patients with decompensated cirrhosis with direct acting antiviral therapy (DAA), but treatments do not always improve symptoms of decompensation or alter the course of liver failure,” wrote co-first author Z. Gordon Jiang, MD, PhD, Hepatology, Beth Israel Deaconess Medical Center, Boston, MA, and coauthors.
Although previous clinical trials have indicated that viral eradication using DAAs in HCV patients with decompensated cirrhosis results in improved Model for End-Stage Liver Disease (MELD) and Child-Pugh-Turcotte (CPT) scores, this improvement may not be linked to clinical or transplantation-free survival benefits in these patients.
“The term MELD purgatory has been used to describe some patients who experience viral eradication, have an improvement in the biochemical parameters of the MELD score, yet remain decompensated post-treatment,” the authors wrote.
The investigators stressed the importance of discovering the “point of no return,” which is the degree of liver dysfunction at which conventional HCV treatment no longer provides a benefit.
“Pretreatment predictors of benefit are needed to guide patient selection for therapy and, more importantly, identify a group of patients in whom therapy is futile and who should undergo liver transplantation and DAA therapy post-transplantation,” Dr. Jiang and coauthors wrote.
To this end, the investigators engaged in a retrospective analysis of four clinical trials involving sofosbuvir-based interferon-free DAA therapy in chronic HCV patients with decompensated cirrhosis (502 CPT B patients, 120 CPT C patients, 71.9% male, median age 59 years). Among subjects, the overall sustained virologic response (SVR) at 12 weeks post-treatment was 85% and the median follow-up period was 255 days.
The primary outcome for this study included variables that decreased the CPT score to CPT class A compensated cirrhosis. The researchers found that several pretreatment baseline factors had robust associations with a reduction to CPT class A after DAA therapy.
To devise the BE3A score to predict clinical improvement, they identified five of these factors with the highest associations:
- BMI < 25
- no Encephalopathy
- no Ascites
- ALT > 60 IU/L
- Albumin > 3.5 g/dL
The BE3A score, which is now available as an online calculator, can be used to predict the ratio of achieving CPT A by duration of treatment in weeks. A BE3A score of 4 or 5 was associated with a 75% chance of achieving CPT A at 36 weeks, while a score of 1 was associated with a 25% chance and a score of 0 was associated with a <5% chance of achieving CPT A at 36 weeks.
One limitation of this study was that outcomes in the analyzed clinical trials were limited to 36 weeks, so longer studies are needed to figure out whether clinical improvement is maintained over time.
“Our study identifies the subset of patients with decompensation who are likely to derive benefit from treatment and who should be urgently considered for antiviral DAA therapy,” the authors concluded. “A simple scoring system (BE3A) can be used as a shared decision-making tool to quantify the potential benefits of DAA in patients with decompensated cirrhosis.”
To use the calculator online, go to www.be3ascore.com.