Efficacy of thymosin ?1 in patients with chronic hepatitis B: A randomized, controlled trial

Chien, Rong‐Nan; Liaw, Yun–Fan; Chen, T C; Yeh, Chau‐Ting; Sheen, I‐Shyan

doi:10.1002/hep.510270527

Cited by 123 publications

(90 citation statements)

References 29 publications

(26 reference statements)

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“…Clinical trials have shown that thymosin is well tolerated but data on efficacy are conflicting. [220][221][222][223] Thus, more studies are needed before thymosin can be recommended for treatment of chronic hepatitis B.…”

Section: Other Therapiesmentioning

confidence: 99%

Chronic hepatitis B

2001

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PREAMBLEThese guidelines have been written to assist physicians and other health care providers in the recognition, diagnosis, and management of patients chronically infected with the hepatitis B virus (HBV). They are intended to suggest preferable approaches to the clinical management of chronic hepatitis B. The recommendations are flexible and are not intended as the only acceptable approach to management and treatment. As the appropriate course of treatment will vary in light of the relevant facts and circumstances surrounding each individual patient with chronic hepatitis B, guidelines are not intended to define the applicable standard of medical care and may be updated periodically as new information becomes available.These guidelines were developed under the auspices of, and approved by, the Practice Guidelines Committee of the American Association for the Study of Liver Diseases. They should be taken as guidelines and not "standards of care." Data used to support the recommendations made were obtained by a literature search of peer-reviewed articles concerning the natural history, diagnosis, and treatment of chronic hepatitis B. In addition, the proceedings of a recent National Institutes of Health workshop on the "Management of Hepatitis B" were considered in the development of these guidelines. 1 The strength of each recommendation is categorized based on the quality of evidence in the literature according to the rating system indicated in Table 1. 2

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Section: Other Therapiesmentioning

confidence: 99%

Chronic hepatitis B

2001

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“…Treatment with thymosin a 1 1.6 mg twice weekly for 6 and 12 months showed a complete response, defined as ALT normalization, undetectable HBV DNA by solution hybridization assay and HBeAg loss at 12 months after the end of therapy in 40-45% and 32% of treated HBeAg-positive patients [66,67]. HBV genotype B responded to therapy better than genotype C (52% vs. 24%, P = 0.036) [67].…”

Section: Thymosin a 1 In Chronic Hepatitis Bmentioning

confidence: 95%

Reviews for APASL guidelines: immunomodulator therapy of chronic hepatitis B

Piratvisuth

2008

Hepatol Int

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The primary aim of immunomodulator therapy is to help the natural human immune system to mount a defense against hepatitis B virus. IFN-a has been used for the treatment of HBeAg-positive and HBeAg-negative chronic hepatitis B for over two decades and has been shown to be effective in suppressing HBV replication and in inducing serological response leading to long-term clinical benefits. IFN-a has been used in patients with wellcompensated cirrhosis with comparable or better response to that in non-cirrhotic patients. IFN-a therapy in patients with cirrhosis has a similar side effect profile as in those without cirrhosis. However, IFN-a is contraindicated in patients with overt or decompensated cirrhosis. Pegylated IFN-a has been shown to be effective in treatment of chronic hepatitis B with sustained response rate in about one-third of the treated patients. Peg IFN-a treatment in non-responders to lamivudine or adefovir dipivoxil showed similar response rate to that seen in naïve patients. Thymosin a 1 is effective in treatment of HBeAg-positive and HBeAg-negative chronic hepatitis B with a significantly increasing virological response over time after therapy.

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“…The structure of Tai is composed of twenty-eight amino acids and the molecular weight is 3,108. Next Toti has been shown to modulate T-cell function, to promote endogenous IFN-y, and interleukin-2 production by human lymphocytes and to increase lymphocyte interleukin-2 receptor expression (6,22).…”

Section: Clinical Safetymentioning

confidence: 99%

“…However, we found that the efficacy of low-dose (0.8 mg) Toti was not inferior to that of highdose (1.6 mg) Toti. With respect to the total dose of Toti, Chien et al reported that the response rate of patients treated with Toti for 26 weeks was not statistically different from that of patients treated for 52 weeks (6). Toti has pharmacological actions with modulate T-cell function to promote endogenous IFN-y, interleukin-2 production and to stimulate natural killer activity.…”

Section: Clinical Safetymentioning

confidence: 99%

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A Pilot Study of Thymosin .ALPHA.1 Therapy for Chronic Hepatitis B Patients

et al. 2003

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Objective The efficacy of thymosin alpha 1 (Tai) in patients with chronic hepatitis B still requires confirmation. We, therefore, evaluated the efficacy of therapy in patients with chronic hepatitis B.Methods Sixteen patients were randomly assigned into one of two groups, treated with 0.8mg of Tai (low dose group; n=8) or 1.6 mg Tai (high dose group; n=8), administered six times weekly for two weeks, followed by twice weekly for another 22 weeks. Responders were defined as patients having clearance of hepatitis B e antigen by radioimmunoassay and negativity of hepatitis B virus (HBV)-DNAby branched DNAsignal amplification and normalization of serum alanine aminotransferase (ALT) 24 months after initiation of Tai therapy. Transient acute exacerbation was defined as an increase of more than 300 IU// in serum ALT level during Tai therapy. Results The response rate was 37.5% (6/16). Tai therapy had a significant effect when, 1) transient acute exacerbation was present (p=0.0029), 2) the serum HBV-DNA level was <100 Meq/ml prior to the commencementof Tai therapy (p=0.0063). The difference between low and high dose groups was not statistically significant (p= 0.608). ConclusionThe results of this trial show that: 1) a 24-week course of Tai could be a worthwhile strategy for chronic hepatitis B patients with a serum HBV-DNA level of less than 100 Meq/ml; and 2) patients with a transient acute exacerbation during Tai therapy generally often respond well. (Internal Medicine 42: 941-946, 2003)

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Efficacy of thymosin ?1 in patients with chronic hepatitis B: A randomized, controlled trial

Cited by 123 publications

References 29 publications

Chronic hepatitis B

Chronic hepatitis B

Reviews for APASL guidelines: immunomodulator therapy of chronic hepatitis B

A Pilot Study of Thymosin .ALPHA.1 Therapy for Chronic Hepatitis B Patients

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