HepQuant-STAT predicts HCV patients' risk for clinical outcomes

SAN DIEGO — The HepQuant-STAT, a liver function test, was more accurate in predicting patients’ risk for hepatitis C virus infection clinical outcomes compared with a liver biopsy, according to data from the HALT-C trial presented at IDWeek 2015.

Steve M. Helmke, PhD, division of Gastroenterology and Hepatology, University of Colorado, and colleagues, including Gregory T. Everson, MD, also of University of Colorado, enrolled 220 patients with liver fibrosis or cirrhosis, but very low Child Pugh scores for the analysis and compared them with 29 healthy controls.

Gregory T. Everson

“In the HALT-C trial, chronic HCV patients without any prior clinical outcomes at baseline were given biopsies scored for fibrosis fat and inflammation and given a set of experimental liver function tests,” Helmke said in the presentation.

The tests included HepQuant-STAT (HepQuant, LLC), a very simple liver function test, according to Helmke. Patients drank a small cup of juice that contained 40 mg tetra-deuterated cholic acid (d4-CA). An hour later, researchers took a single blood drop of blood from each patient and analyzed for the concentration of d4-CA.

The patients were followed for up to 8 years, with the average follow-up being 5 years. Over the course of follow-up, 52 patients experienced at least one clinical outcome and most experienced more than one outcome, according to Helmke.

“Almost all the patients first experienced an increase in [Child-Turcotte-Pugh] score, then two-thirds of patients went on to clinical decompensation and a fraction succumbed to their disease. So the point here is these outcomes are occurring many years after we’ve done this baseline testing,” Helmke said.

According to the presentation, healthy controls had d4-CA levels of 0.37 ± 0.11 µm compared with patients with HCV without clinical outcomes (0.94 ± 0.52 µm) and patients with HCV with clinical outcomes (1.76 ± 0.99 µm).

“Patients who did not have any clinical outcomes still had fibrosis and cirrhosis and their serum levels were significantly higher than controls,” Helmke said. “The patients who were going to have future clinical outcomes had at baseline, even higher levels of cholic [acid].”

The area under the receiver operating curve was 0.8 for HepQuant-STAT vs. 0.75 for liver biopsy; sensitivity was 75% for HeoQuant0STAT vs. 71% for liver biopsy; and specificity was 74% for HepQuant-STAT vs. 66% for liver biopsy. The HepQuant-STAT showed improvement over biopsy for all measures, according to the presentation.

Further analyses showed HepQuant-STAT was correlated with biopsy fibrosis, (R² = 0.23), but not fat or inflammation. Also, 41% of patients with cirrhosis were at low risk and 22% of patients with noncirrhotic fibrosis were at high risk for clinical outcomes.

Helmke concluded: “HepQuant-STAT, a simple liver function test, could stratify HCV patients by their risk of clinical outcomes better than biopsy. HepQuant-STAT could help prioritize for antiviral treatment those HCV patients at higher risk of clinical outcomes.” – by Melinda Stevens

Reference:

Helmke SM, et al. Abstract 1973. Presented at: IDWeek; Oct. 7-11, 2015; San Diego.

Disclosure: Helmke reports being a co-inventor on US Patent 9,091,701, which covers various quantitative liver function tests, including HepQuant-STAT. Please see the abstract for a full list of all authors’ relevant financial disclosures.