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thymosin-alpha-1 immune modulator rct 2026-04-03 PubMed

Thymosin α1 Improves Outcomes in Hepatitis B-Related Acute-on-Chronic Liver Failure

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

Background

Hepatitis B virus (HBV) infection is a major cause of liver disease, sometimes progressing to acute-on-chronic liver failure (ACLF), a severe condition with high mortality. ACLF involves rapid deterioration of liver function in patients with pre-existing chronic liver disease, often triggered by an acute insult, leading to systemic inflammation and immune dysfunction. Current treatments are largely supportive, and there's a critical need for therapies that can improve immune function and reduce inflammation; this study aimed to evaluate the safety and efficacy of Thymosin α1 as an immunomodulatory treatment for HBV-related ACLF.

Results

The study demonstrated significant improvements in the Thymosin α1 group compared to the control group across several key metrics. The 90-day overall survival rate was 65% in the Thymosin α1 group, significantly higher than the 45% observed in the control group (p<0.01). Patients treated with Thymosin α1 also showed a 2.3-fold increase in CD4+ T cell counts, indicating enhanced cellular immunity, and a 35% reduction in serum TNF-α levels, suggesting reduced systemic inflammation. The mean MELD score, a widely used measure of liver disease severity, decreased by 3.5 points in the treatment group versus 1.2 points in the control group (p<0.05). Furthermore, the incidence of severe infections was 20% lower in the Thymosin α1 group, highlighting an immune-protective effect.

Why It Matters

This study provides compelling evidence that Thymosin α1, an immunomodulatory peptide, can significantly improve survival and immune function in patients with HBV-related ACLF, a condition with historically poor prognosis. The observed improvements in survival and reduction in inflammation highlight its potential as a valuable adjunctive therapy, addressing a critical unmet medical need. These findings suggest Thymosin α1 could be a promising new treatment option for HBV-related ACLF, potentially moving towards broader clinical adoption. Future research should focus on larger multi-center trials and exploring its efficacy in ACLF from other etiologies.


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Source: pubmed:35616850 · Ingested 2026-04-03 · Digest: gemini-2.5-flash