http://orcid.org/0000-0002-8039-0699
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Abstract
Objective: Detecting significant fibrosis and cirrhosis remains important in treatment and follow-up of patients with chronic hepatitis C Infection (CHC). The aim of this study was to assess the ability of PRO-C3 to identify significant fibrosis (Ishak score ≥3) and cirrhosis (Ishak score ≥5) both as a single test and as a part of algorithms.
Materials and methods: PRO-C3 was assessed in baseline samples from the NORDynamIC trial. 270 patients were stratified into groups according to baseline biopsy. Baseline APRI, FIB-4 and GUCI scores were available for comparison in 232 patients.
Results: PRO-C3 increased with Ishak scores (p = .001). Area under the curve (AUC) for significant fibrosis was 0.75 (95% CI 0.68–0.81) and 0.76 (95% CI 0.68–0.84) for cirrhosis. FIB-4, APRI and GUCI had similar AUCs. In a PRO-C3 algorithm including age, platelet count, body mass index (BMI) and international normalised ratio (INR), the diagnostic efficacy improved to 0.85 (CI 0.80–0.89) and 0.90 (IQR 0.84–0.96) for significant fibrosis and cirrhosis, respectively.
Conclusions: In our study, PRO-C3 was an independent predictor of fibrosis stage, and may play an important role in managing CHC patients.
Disclosure statement
MK, DJL and MJN are employed at Nordic Bioscience, a privately owned company responsible for the development of PRO-C3. MK and DJL are stock holders in the company. PBC has received research grants from Abbvie, Gilead and MSD not related to this study. The parent study was supported by a grant from Roche. The other authors have no potential conflicts of interests and none of the authors have received any payment for the work pertained to this study.