A Prospective Analysis of the Prognostic Value of Biomarkers (FibroTest) in Patients with Chronic Hepatitis C

TLDR

FibroTest is a noninvasive biomarker assay that estimates liver fibrosis severity and offers an alternative to liver biopsy in chronic hepatitis C. The study aimed to compare the 5‑year prognostic performance of FibroTest with biopsy staging for predicting cirrhosis decompensation and survival in chronic HCV patients. In a prospective cohort of 537 patients, FibroTest and liver biopsy were performed on the same day, categorizing patients into severe (>0.58), moderate (0.32–0.58), and minimal (<0.32) fibrosis groups. FibroTest demonstrated superior predictive accuracy for HCV complications and deaths (AUROC 0.96 vs 0.91 and 0.96 vs 0.87, respectively) and maintained significance after multivariate adjustment, showing prognostic value comparable to biopsy.

Abstract

Abstract Background: FibroTest, a noninvasive method of measuring biomarkers of liver fibrosis, is an alternative to liver biopsy for determining the severity of chronic hepatitis C virus (HCV) infection. We compared the 5-year prognostic value of the FibroTest with biopsy staging for predicting cirrhosis decompensation and survival in patients with chronic HCV infection. Methods: Fibrosis stage was assessed on the same day by FibroTest and biopsy in a prospective cohort of 537 patients. Disease classification at baseline was 157 patients with severe fibrosis (FibroTest &amp;gt;0.58), 137 with moderate fibrosis (FibroTest 0.32–0.58), and 243 with no or minimal fibrosis (FibroTest &amp;lt;0.32). Results: In 64 untreated patients with severe fibrosis, survival without HCV complications was 73% [95% confidence interval (CI), 59%–086%; 13 complications], and survival without HCV-related death was 85% (95% CI, 73%–96%; 7 HCV deaths). Survival rates were higher in patients with moderate fibrosis, [99% (95% CI, 97%–100%; 1 complication; P &amp;lt;0.001) and 100% (no HCV death; P &amp;lt;0.001) for patients with and without HCV-related complications, respectively], and in patients with minimal fibrosis [100% (no complication; P &amp;lt;0.001 vs severe) and 100% (no HCV death; P &amp;lt;0.001 vs severe), respectively]. FibroTest was a better predictor than biopsy staging for HCV complications, with area under the ROC curves (AUROC) = 0.96 (95% CI, 0.93%–0.97%) vs 0.91 (95% CI, 0.85%–0.94%; P = 0.01), respectively; it was also a better predictor for HCV deaths: AUROC = 0.96 (95% CI, 0.93%–0.98%) vs 0.87 (95% CI, 0.70%–0.94%; P = 0.046), respectively. The prognostic value of FibroTest was still significant (P &amp;lt;0.001) in multivariate analyses after taking into account histology, treatment, alcohol consumption, and HIV coinfection. Conclusion: The FibroTest measurement of HCV biomarkers has a 5-year prognostic value similar to that of liver biopsy.