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Study · Systematic review · 2020

8 results

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 D, Xing HY, Li C, Wang XF, Hou M, Li B, Chen JH

BMC gastroenterology19 Oct 2020Cited by 4 (Europe PMC)

PMID33076834 (opens in a new tab)PMCIDPMC7574490 (opens in a new tab)DOI10.1186/s12876-020-01477-8 (opens in a new tab)PepBankPUB-33076834
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Summary

BackgroundPrevious 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.MethodsThe 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 I2 values.ResultsSeven 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).ConclusionsETV 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.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanSystematic reviewEfficacy outcome

    In HBV-related cirrhosis, entecavir plus thymosin α1 gave a higher complete response than entecavir alone in a meta-analysis (RR = 1.18; 95% CI, 1.07-1.30).

    In plain wordsIn people with hepatitis B cirrhosis, adding thymosin α1 to entecavir gave more complete responses than entecavir alone.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreaseComplete response
    Study

    n: not reported in source

    Comparator
    Entecavir monotherapy
    Outcome group
    Antiviral activity · Infection
    Studied dose
    Dose not stated

    Measurements

    RR
    1.18
    complete response

    Source sentences

    Summary
    Compared with ETV monotherapy, ETV plus Tα1 combination therapy led to a higher complete response (RR = 1.18; 95% CI, 1.07-1.30).
    2 context sentences
    Summary · context
    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.
    Summary · context
    Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis.
  2. 02HumanSystematic reviewEfficacy outcome

    In HBV-related cirrhosis, the HBV DNA undetectable rate 24 weeks after treatment was higher with entecavir plus thymosin α1 than with entecavir alone (RR = 1.91).

    In plain wordsIn people with hepatitis B cirrhosis, adding thymosin α1 to entecavir gave more undetectable virus 24 weeks after treatment than entecavir alone.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreaseHBV DNA undetectable rate 24 weeks post treatment
    Study

    n: not reported in source

    Comparator
    Entecavir monotherapy
    Outcome group
    Antiviral activity · Infection
    Studied dose
    Dose not stated

    Measurements

    RR
    1.91
    HBV DNA undetectable, 24 weeks post treatment

    Source sentences

    Summary
    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).
    2 context sentences
    Summary · context
    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.
    Summary · context
    Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis.
  3. 03HumanSystematic reviewEfficacy outcome

    In HBV-related cirrhosis, the HBeAg loss rate 24 weeks after treatment was higher with entecavir plus thymosin α1 than with entecavir alone (RR = 2.05).

    In plain wordsIn people with hepatitis B cirrhosis, adding thymosin α1 to entecavir gave more HBeAg loss 24 weeks after treatment than entecavir alone.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreaseHBeAg loss rate 24 weeks post treatment
    Study

    n: not reported in source

    Comparator
    Entecavir monotherapy
    Outcome group
    Antiviral activity · Infection
    Studied dose
    Dose not stated

    Measurements

    RR
    2.05
    HBeAg loss, 24 weeks post treatment

    Source sentences

    Summary
    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).
    2 context sentences
    Summary · context
    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.
    Summary · context
    Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis.
  4. 04HumanSystematic reviewEfficacy outcome

    In HBV-related cirrhosis, after 48 and 52 weeks of treatment, entecavir plus thymosin α1 did not differ significantly from entecavir alone.

    In plain wordsIn people with hepatitis B cirrhosis, adding thymosin α1 to entecavir made no clear difference after 48 and 52 weeks of treatment.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeResponse at 48 and 52 weeks of treatment
    Study

    n: not reported in source

    Comparator
    Entecavir monotherapy
    Outcome group
    Antiviral activity · Infection
    Studied dose
    Dose not stated

    Measurements

    RR
    1.07
    48 weeks
    RR
    1.17
    52 weeks

    Source sentences

    Summary
    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).
    2 context sentences
    Summary · context
    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.
    Summary · context
    Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis.
  5. 05HumanSystematic reviewEfficacy outcome

    In HBV-related cirrhosis, the HBsAg loss rate at week 52 did not differ significantly between entecavir plus thymosin α1 and entecavir alone.

    In plain wordsIn people with hepatitis B cirrhosis, adding thymosin α1 to entecavir made no clear difference in HBsAg loss at week 52.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeHBsAg loss rate at week 52
    Study

    n: not reported in source

    Comparator
    Entecavir monotherapy
    Outcome group
    Antiviral activity · Infection
    Studied dose
    Dose not stated

    Measurements

    RR
    1.03
    HBsAg loss at week 52

    Source sentences

    Summary
    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).
    2 context sentences
    Summary · context
    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.
    Summary · context
    Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis.
  6. 06HumanSystematic reviewEfficacy outcome

    In HBV-related cirrhosis, some biochemical parameters were improved by entecavir plus thymosin α1 compared with entecavir alone, with significant heterogeneity.

    In plain wordsIn people with hepatitis B cirrhosis, some blood liver tests improved more with thymosin α1 plus entecavir than with entecavir alone; studies varied.

    Peptide
    Thymosin alpha-1
    Outcome
    Direction not reportedBiochemical parameters
    Study

    n: not reported in source

    Comparator
    Entecavir monotherapy
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated

    Source sentences

    Summary
    In comparison with ETV alone, the some biochemical parameters and liver fibrosis were obviously improved by ETV plus Tα1, and there was significant heterogeneity.
    2 context sentences
    Summary · context
    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.
    Summary · context
    Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis.
  7. 07HumanSystematic reviewEfficacy outcome

    In HBV-related cirrhosis, liver fibrosis was improved by entecavir plus thymosin α1 compared with entecavir alone, with significant heterogeneity.

    In plain wordsIn people with hepatitis B cirrhosis, liver fibrosis improved more with thymosin α1 plus entecavir than with entecavir alone; studies varied.

    Peptide
    Thymosin alpha-1
    Outcome
    Direction not reportedLiver fibrosis
    Study

    n: not reported in source

    Comparator
    Entecavir monotherapy
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated

    Source sentences

    Summary
    In comparison with ETV alone, the some biochemical parameters and liver fibrosis were obviously improved by ETV plus Tα1, and there was significant heterogeneity.
    2 context sentences
    Summary · context
    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.
    Summary · context
    Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis.
  8. 08HumanSystematic reviewSafety outcome

    In HBV-related cirrhosis, the number of adverse events was lower with entecavir plus thymosin α1 than with entecavir alone (RR = 0.48; 95% CI, 0.24-0.95).

    In plain wordsIn people with hepatitis B cirrhosis, adding thymosin α1 to entecavir led to fewer adverse events than entecavir alone.

    Peptide
    Thymosin alpha-1
    Outcome
    DecreaseNumber of adverse events
    Study

    n: not reported in source

    Comparator
    Entecavir monotherapy
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    RR
    0.48
    adverse events

    Source sentences

    Summary
    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).
    2 context sentences
    Summary · context
    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.
    Summary · context
    Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 3Current

    9 Oct 2026, 18:17 UTC

    Study results updated

  2. Version 2

    9 Oct 2026, 03:03 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 03:02 UTC

    First added · source update from Europe PMC

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