Comparison of interteron α2β monotherapy with the combination of thymosin α1 and interferon α2b in the treatment of anti-HBe-postive chronic hepatitis B in turkey

Saruç, Murat; Yuceya, Hakan; Küçükmetin, Nurten Türkel; Demir, Mehmet Akif; Kandiloğlu, Ali Rıza

doi:10.1016/s0016-5085(08)81888-4

Cited by 8 publications

(10 citation statements)

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“…The results from trials in this indication have been quite positive, as shown in Figure 4. Treatment with thymosin alpha 1 alone has been shown to lead to responses ranging from 25% to 41%, similar to those seen for treatment with interferon alpha (IFN) alone 24 as concluded in a meta‐analysis, 25 whereas combination therapy is even more effective: thymosin alpha 1 combined with lamivudine 26 or IFN 27 has been shown to result in up to 70% response rates. By comparison, lamivudine and adefovir alone have been published as providing a response of only 8–16%, 28,29 whereas placebo or no treatment of hepatitis B can result in 10–15% spontaneous responses 24…”

Section: Clinical Trials Evaluating Thymosin Alpha One's Use As a Vacmentioning

confidence: 69%

Thymosin alpha 1: past clinical experience and future promise

Tuthill

Rios

McBeath

2010

Annals of the New York Academy of Sciences

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Thymosin alpha 1, originally isolated as the compound responsible for reconstitution of immune function in thymectomized animal models, has enjoyed a wide-ranging clinical development program over the past decades, extending across multiple companies, indications, countries, and continents. This paper provides an overview of this complex picture. The extensive clinical studies began with small studies conducted with an impure mixture of peptides under the aegis of physician-sponsored INDs submitted to the US FDA, in subjects with primary immune deficiency such as DiGeorge syndrome. Subsequent studies ranged all the way to large phase-3 trials conducted with synthetically produced thymosin alpha 1 and hundreds of patients, in many countries including the United States, Italy, and China.

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Section: Clinical Trials Evaluating Thymosin Alpha One's Use As a Vacmentioning

confidence: 69%

Thymosin alpha 1: past clinical experience and future promise

Tuthill

Rios

McBeath

2010

Annals of the New York Academy of Sciences

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“…Our uncontrolled study with 21 patients with HBeAg‐negative CHB without evidence of cirrhosis showed that a 26‐week combination course of 1.6 mg of thymosin‐α1 twice a week and 10 MIU of IFN‐α three times a week, followed by IFN monotherapy at the same dose for another 26 weeks, achieved biochemical and virological ETR in 87.7% of the patients 39. Seventy‐six percent of these patients became sustained responders, with normal ALT and negative HBV DNA, at the end of 78 weeks.…”

Section: Discussionmentioning

confidence: 95%

Long-term outcomes of thymosin-α1 and interferon α-2b combination therapy in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B

Saruç

Ozden

Türkel

et al. 2003

Journal of Pharmaceutical Sciences

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“…CTL and NK enhancement surely play a role in these results, but, once again, the hypothesis of the increased expression of MHC I antigens could be particularly relevant, given the specific lack of MHC class I antigens expression in HBV‐infected hepatocytes. This trial provided the first evidence of the effectiveness of the combined approach and was followed by many other trials 13–15 ( 4) that confirmed the initial observations and gave some important indication: evidence of the “late response,” unique of Tα1 and opposite to IFN, the response also in “IFN nonresponders patients” and in precore mutants, and the dose–response effect ( 5). 16–19 …”

Section: Use Of Tα1 In Infectious Diseasesmentioning

confidence: 86%

Thymosin Alpha 1

Garaci

Favalli

Pica

et al. 2007

Annals of the New York Academy of Sciences

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After the initial dramatic effects, observed in a Lewis lung carcinoma animal model, using a combination of thymosin alpha 1 (Talpha1) and interferon (IFN) after cyclophosphamide, a number of other preclinical models in mice (Friend erythroleukemia and B16 melanoma) and in rats (DHD/K12 colorectal cancer liver metastasis) have confirmed the efficacy of the combination therapy with Talpha1 and either IFN or IL-2 plus chemotherapy. These results provided the scientific foundation for the first clinical trials using Talpha1 in combination with BRMs and/or chemotherapy. Pivotal trials in advanced non-small cell lung cancer (NSCLC) and melanoma with Talpha1 and IFN-alpha low doses after cis-platinum or dacarbazine produced the first evidence of the high potentiality of this approach in the treatment of human cancer. The combination of Talpha1 and IFN-alpha was also used in patients affected by chronic B and C hepatitis including IFN-nonresponders and infected by precore mutants or genotype 1b. Further studies demonstrated additional biological activities clarifying the mechanism of action of Talpha1, partially explaining the synergism with IFN. It has been shown the capacity of activating infected dendritic cells through Toll-like receptor signaling, thus influencing the inflammation balance, and of increasing the expression of tumor, viral, and major histocompatibility complex (MHC) I antigens. Dose-response studies suggested the possibility of improving the efficacy of this molecule reducing the overall toxic. Based on these information two clinical trials are ongoing: a large phase II on advanced melanoma patients treated with Talpha1 at different doses after dacarbazine and a phase III one, on IFN-resistant hepatitis C virus (HCV) patients treated with a triple combination (IFN, ribavirin, and Talpha1).

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Comparison of interteron α2β monotherapy with the combination of thymosin α1 and interferon α2b in the treatment of anti-HBe-postive chronic hepatitis B in turkey

Cited by 8 publications

References 0 publications

Thymosin alpha 1: past clinical experience and future promise

Thymosin alpha 1: past clinical experience and future promise

Long-term outcomes of thymosin-α1 and interferon α-2b combination therapy in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B

Thymosin Alpha 1

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