Safety and efficacy of Thymosin α1 in the treatment of hepatitis B virus-related acute-on-chronic liver failure: a randomized controlled trial

Background/purpose of the study Mortality from hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is high. Severe infection is the most important complication that affects the outcomes of ACLF patients. Thymosin alpha 1 (T alpha 1) can improve immune imbalance and this study aimed to investigate the safety and efficacy of T alpha 1 treatment for HBV-related ACLF. Methods From 2017 to 2019, 120 patients with HBV-related ACLF were enrolled in this open-label, randomized, and controlled clinical trial (ClinicalTrial ID: NCT 03082885). The control group (N= 58) was treated with standard medical therapy (SMT) only. The experimental group (N= 56) was subcutaneously injected with 1.6 mg of T alpha 1 once a day for the first week and then twice a week from week 2 to week 12. Results The 90-day cumulated liver transplantation free survival rate of the T alpha 1 group was 75.0% (95% confidence interval 63.2-86.8%) versus 53.4% (95% confidence interval 39.7-67.1%) for the SMT group (p = 0.030). No significant difference was found in the survival using competitive risk analysis. The incidences of new infection and hepatic encephalopathy in the T alpha 1 group were much lower than those in the SMT group (32.1% vs 58.6%, p = 0.005; 8.9% vs 24.1%, p = 0.029, respectively). Mortality from severe infection in the SMT group was higher than in the T alpha 1 group (24.1% vs 8.9%, p = 0.029). Conclusion T alpha 1 is safe for patients with HBV-related ACLF and significantly improves the 90-day liver transplantation-free survival rate. There may be a subgroup which may benefit from T alpha 1 therapy by the mechanism of preventing infection.

Automated summary

This study investigated the safety and efficacy of Thymosin alpha 1 (T alpha 1) treatment for hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF). The results showed that T alpha 1 treatment improved the 90-day liver transplantation-free survival rate and reduced the incidence of new infections and hepatic encephalopathy in ACLF patients. Furthermore, the mortality rate from severe infection was lower in the T alpha 1 group compared to the standard medical therapy (SMT) group.