Abstract
BACKGROUND AND AIMS: Type IV collagen 7S (COL4-7S) is a simple, noninvasive biomarker for liver fibrosis. However, whether COL4-7S can detect advanced fibrosis (AF) and predict the prognosis of metabolic dysfunction-associated steatotic liver disease (MASLD) is unclear. We examined the clinical efficacy of COL4-7S in diagnosing AF and determining MASLD prognosis. METHODS: Overall, 881 Japanese patients with biopsy-proven nonalcoholic fatty liver disease between 1994 and 2020 were enrolled. Serum COL4-7S levels were measured by radioimmunoassay, and 2 cutoff points were set as 5.1 ng/mL and 7.2 ng/mL. The patients were assigned to 3 groups based on the COL4-7S level. Cox regression analysis was used to estimate the predictive performance of COL4-7S for liver-related events (LREs). RESULTS: Overall, 866 MASLD patients were enrolled. The median follow-up period was 4.3 years. Thirty-one patients developed LREs. The area under the curve for COL4-7S in patients with AF was 0.847. The adjusted hazard ratios for LREs in 4.8 ≤ COL4-7S < 6.8 and COL4-7S ≥6.8 patients were 6.0 (P = .009) and 27.9 (P < .001) compared with COL4-7S <4.8, and the adjusted hazard ratio of AF on liver biopsy was 1.6 (P = .286). The incidence rate of LREs was low when the Fibrosis-4 Index (FIB-4) <1.30. When the FIB-4 >1.30, effective stratification of the LRE risk group was possible by stratification of COL4-7S. A combination of FIB-4 and COL4-7S stratified risk groups for future LRE development more effectively than when used singly. CONCLUSION: COL4-7S accurately diagnosed AF and predicted LREs. COL4-7S and a combination of FIB-4 and COL4-7S might help physicians estimate the prognosis of future LRE risk.