Progression of the FIB-4 index among patients with chronic HCV infection and early liver disease.

Historical paired liver biopsy studies are likely to underestimate current progression of disease in patients with chronic hepatitis C virus (HCV) infection. We aimed to assess liver disease progression according to the non-invasive Fibrosis-4 (FIB-4) index in patients with chronic HCV and early disease. Patients diagnosed with chronic HCV and FIB-4 <3.25 from four international liver clinics were included in a retrospective cohort study. Follow-up ended at start of antiviral therapy resulting in sustained virological response, at time of liver transplantation or death. Primary outcome of advanced liver disease was defined as FIB-4 >3.25 during follow-up. Survival analyses were used to assess time to FIB-4 >3.25.In total, 4286 patients were followed for a median of 5.0 (IQR 1.7-9.4) years, during which 41 071 FIB-4 measurements were collected. At baseline, median age was 47 (IQR 39-55) years, 2529 (59.0%) were male, and 2787 (65.0%) patients had a FIB-4 <1.45. Advanced liver disease developed in 821 patients. Overall, 10-year cumulative incidence of advanced disease was 32.1% (95% CI 29.9% to 34.3%). Patients who developed advanced disease showed an exponential FIB-4 increase. Among patients with a presumed date of HCV infection, cumulative incidence of advanced disease increased 7.7-fold from 20 to 40 years as opposed to the first 20 years after HCV infection. The rate of advanced liver disease is high among chronic HCV-infected patients with early disease at time of diagnosis, among whom liver disease progression accelerated over time. These results emphasise the need to overcome any limitations with respect to diagnosing and treating all patients with chronic HCV across the globe.

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Competing interests: LK, NSE, CW, SvH, OC, JV and RAdM report no conflict of interest. RM received financial compensation for consultancy from AbbVie. AP is an employee of Merck & Co. RJdK declares that the Erasmus University Medical Center, on behalf of RJdK, received honoraria for consulting/speaking from Gilead, Janssen-Cilag, Bristol-Myers Squibb (BMS), AbbVie, MSD, Roche and Norgine, and received research grants from Gilead, Janssen-Cilag, BMS and Roche. BEH has consulted for and received grant/research support from Intercept Pharmaceuticals. SZ reports consultancies for AbbVie, BMS, Gilead, Janssen and Merck. TV has received grants from Gilead Sciences and BMS; is a consultant for Janssen Pharmaceuticals, Gilead Sciences, AbbVie and BMS; and a sponsored lecturer for W L Gore, Gilead Sciences, BMS and AbbVie. HLAJ has served as consultant for and has received grants from AbbVie, Arbutus, BMS, Enyo, Gilead Sciences, Janssen, Medimmune, Merck, Roche, Vir Biotechnology and Viroclinics. JJF has consulted for Abbott, AbbVie, Gilead, Enanta and Roche; and has received grant/research support from AbbVie, Eiger, Gilead, Janssen and Wako/Fujifilm. AJvdM received financial compensation for lecture activities for Zambon and research funding from Gilead, MSD, AbbVie and Zambon.