Biejia-Ruangan enhances the efficacy of entecavir in reversing liver cirrhosis in patients with chronic HBV infection: A seven-year open-label follow-up cohort study

Abstract

Ethnopharmacological relevance: Biejia-Ruangan (BRG) has been approved in China as an antifibrotic traditional Chinese medicine for patients with chronic liver diseases; however, data on the reversal of hepatitis B-related cirrhosis by BRG are still limited.

Aim of the study: To investigate the reversal effect of BRG in patients with hepatitis B-related cirrhosis.

Materials and methods: Hepatitis B-related cirrhotic patients who received either entecavir (ETV) monotherapy or combination therapy with ETV and BRG for 7 years, were analysed. The primary endpoints included the regression of liver cirrhosis, liver histological improvement, and a significant reduction in the LSM value.

Results: In total, 153 cirrhotic patients were enrolled, of whom 63 received ETV alone and 90 received both ETV and BRG. Ninety-four patients, of whom 39 received ETV monotherapy and 55 received both ETV and BRG, underwent liver biopsies at both the second and seventh years of treatment. Although the rate of liver cirrhosis regression did not significantly increase after two years of antifibrotic therapy in patients who received ETV and BRG combination therapy (43.3 % vs. 38.1 %, P = 0.217), the median LSM decreased significantly (8.3 kPa vs. 11.2 kPa, P = 0.041); after seven years of treatment, a significantly greater rate of liver cirrhosis regression was achieved (55.6 % vs. 38.1 %, P = 0.033), and the LSM value further decreased significantly (6.4 kPa vs. 11.0 kPa, P = 0.036).

Conclusions: BRG enhances the efficacy of ETV in reversing liver cirrhosis in patients with chronic HBV infection, but this reversal takes a longer time.

Keywords: Biejia-Ruangan; Chronic hepatitis B; Liver cirrhosis; Therapy; Traditional Chinese medicine.