The clinical efficacy and adverse effects of Entecavir plus Thymosin alpha-1 combination therapy versus Entecavir Monotherapy in HBV-related cirrhosis: a systematic review and meta-analysis.
Peng. Dan D; Xing. Hai-Yan HY; Li. Chen C; Wang. Xian-Feng XF; Hou. Min M; Li. Bin B; Chen. Jian-Hong JH
Key Findings
- At 24 weeks, the combo therapy increased the chance of a complete clinical response (RR = 1.18) and nearly doubled the rates of undetectable HBV DNA (RR = 1.91) and HBeAg loss (RR = 2.05) compared with entecavir alone.
- After 48–52 weeks, there was no significant difference between the combination and entecavir monotherapy for viral suppression or HBsAg loss.
- Adverse events were about half as common with the combination (RR = 0.48), suggesting a modest safety benefit.
Practical Outcomes
- For biohackers, the data suggest thymosin‑alpha‑1 might give a short‑term boost to antiviral therapy in chronic hepatitis B, but it does not provide lasting benefits and the evidence is limited to Chinese cirrhotic patients. It is not a proven or recommended supplement for healthy individuals seeking longevity or performance gains, and more large, diverse trials are needed before considering it in a general protocol.
Summary
Adding the immune‑boosting peptide thymosin‑alpha‑1 to the antiviral drug entecavir gave a slightly better short‑term response in Chinese patients with hepatitis‑B‑related cirrhosis, but the advantage disappeared after about a year and the overall safety profile was modestly better.
Abstract
Previous studies have demonstrated the benefits of thymosin alpha-1 (Tα1) in anti-virus, immunological enhancement and anti-inflammation. However, it is controversial about the efficacy and safety of entecavir (ETV) plus Tα1 combination therapy versus ETV monotherapy in cirrhotic patients with hepatitis B virus (HBV) infection. The systematic review and meta-analysis of randomized clinical trials (RCTs) were performed to evaluate the efficacy and safety of ETV plus Tα1 combination therapy versus ETV monotherapy in HBV-related patients with cirrhosis. We performed a systematic literature search via PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Science and Technology Journals Database (VIP), and Chinese Biological Medicine database (CBM). Relative risk (RR) and standardized mean difference (SMD) with a fixed- or random- effect model were calculated. Heterogeneity was assessed through a Cochrane Q-test and I<sup>2</sup> values. Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis. Compared with ETV monotherapy, ETV plus Tα1 combination therapy led to a higher complete response (RR = 1.18; 95% CI, 1.07-1.30). In post treatment for 24 weeks, the HBV DNA undetectable rate and HBeAg loss rate were higher in ETV plus Tα1 group than in ETV alone group (RR = 1.91; 95% CI, 1.56-2.35; RR = 2.05; 95% CI, 1.62-2.60). However, after 48 and 52 weeks of treatment, there was no significant difference between the combination therapy and ETV monotherapy (RR = 1.07; 95% CI, 0.96-1.18; RR = 1.17; 95% CI, 0.89-1.55). At week 52 of treatment, the HBsAg loss rate of ETV plus Tα1 group was no significance with that of ETV alone group (RR = 1.03; 95% CI, 0.15-7.26). In comparison with ETV alone, the some biochemical parameters and liver fibrosis were obviously improved by ETV plus Tα1, and there was significant heterogeneity. In addition, the number of adverse events was significantly reduced by ETV plus Tα1, compared to ETV alone (RR = 0.48; 95% CI, 0.24-0.95). ETV plus Tα1 might lead to a higher clinical response and a lower comprehensive adverse reaction rate in HBV-related patients with cirrhosis, compared to ETV alone. However, the whole patients included in this meta-analysis were from Chinese mainland, so that more worldwide RCTs with a larger sample size are needed to verify the current findings.
Study Information
pubmed
2020
2020-10-19T00:00:00.000Z
10.1186/s12876-020-01477-8
5
42