The Optimal Cutoffs of Liver Stiffness Measurement for Staging Fibrosis in On-Treatment Patients With Chronic...

Liver stiffness measurement (LSM) cutoffs for diagnosis of liver fibrosis in untreated patients with chronic hepatitis B (CHB) have been well-established. However, the applicability and the optimal LSM cutoffs for patients undergoing antiviral therapy remain unclear.

Adults with CHB who had LSM and liver biopsy on the same day during antiviral therapy were enrolled from 2 clinical studies and their extension observations (NCT01938820, NCT01943617, NCT01938781, and NCT03777969). Liver fibrosis was evaluated according to the METAVIR and Ishak scoring system. The performance of LSM measured by vibration-controlled transient elastography (VCTE) devices was estimated using the area under the receiver operating characteristic curve (AUROC).

A total of 754 patients were enrolled and randomly divided into derivation and validation sets in a ratio of 2:1. Among them, 75.9% of patients (572/754) were male, with a median age of 42.1 years (interquartile range [IQR], 34.0-49.0 years). The median treatment duration was 1.5 years (IQR, 1.0-2.5 years). The cutoffs of LSM for diagnosis of ≥F2, ≥F3, and F4 during antiviral treatment were 7.6 kPa, 7.6 kPa, and 9.0 kPa, respectively, with a sensitivity of 57.5%, 79.2%, and 74.4%, and a specificity of 86.1%, 73.0%, and 77.2%. The area under the receiver operating characteristic curve (AUROC) for diagnosing ≥F2, ≥F3, and F4 were 0.753 (95% confidence interval [CI], 0.712-0.790), 0.818 (95% CI, 0.778-0.848), and 0.815 (95% CI, 0.755-0.846), respectively.

The optimal cutoffs for diagnosing ≥F2/F3 and F4 in on-treatment patients with CHB were 7.6 kPa and 9.0 kPa. These cut-offs could be reliably and repeatedly applied for long-term monitoring of patients with CHB under antiviral therapy.