Entecavir and Thymosin-α Combination Explored for Early Cirrhosis Regression

Chronic hepatitis B virus (HBV) infection is a leading cause of liver cirrhosis, a severe scarring of the liver that can lead to liver failure and cancer. While antiviral therapies like entecavir can suppress the virus, their ability to reverse established cirrhosis, especially in its early stages (histologically confirmed as S4 or Metavir F4), remains an area of active investigation. This study aims to evaluate if adding Thymosin-α to entecavir therapy can enhance the regression of HBV-induced early cirrhosis.

The provided study record outlines the design of a completed clinical trial (NCT01938820) but does not include the specific results or findings. Therefore, quantitative data regarding the efficacy of Thymosin-α in combination with entecavir for cirrhosis regression cannot be reported here. The study was designed to assess the regression rate of liver fibrosis via a second liver biopsy 1.5 years into treatment, comparing the entecavir-only arm to the entecavir plus Thymosin-α arm. The primary objective was to determine if the addition of Thymosin-α could lead to a statistically significant improvement in liver fibrosis regression compared to entecavir monotherapy in patients with HBV-induced early cirrhosis. Regular assessments, including HBVDNA levels, liver function tests, and Fibroscan scores, were conducted every six months to monitor disease progression and treatment response in both groups over the 2-year study duration. The detailed outcomes, including any p-values or percentage reductions in fibrosis, are anticipated to be published separately.