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Thymosin-alpha-1

Thymalfasin, Zadaxin, Thymosin α1

Quick Stats
Studies 759
Trials 63
Score 3
1996 pubmed 60 citations

Combination low-dose lymphoblastoid interferon and thymosin alpha 1 therapy in the treatment of chronic hepatitis B.

Rasi. G G; Mutchnick. M G MG; Di Virgilio. D D; Sinibaldi-Vallebona. P P; Pierimarchi. P P; Colella. F F; Favalli. C C; Garaci. E E

Key Findings

  • 60% of participants (9/15) cleared HBV DNA and normalised ALT after 25 weeks of combined low‑dose IFN‑alpha and thymosin‑alpha‑1.
  • Six of the nine responders became HBsAg‑negative, indicating seroconversion.
  • No significant adverse effects were reported, and liver histology improved in responders.

Practical Outcomes

  • For self‑experimenters with chronic hepatitis B, a protocol of 1 mg thymosin‑alpha‑1 subcutaneously for 4 days plus 3 MU lymphoblastoid IFN‑alpha intramuscularly on day 4, followed by twice‑weekly dosing for ~6 months, showed potential efficacy and good safety. However, the regimen is long, requires injections, and should only be tried under medical supervision pending confirmation from larger trials.

Summary

A small open‑label trial gave people with chronic hepatitis B a combo of low‑dose interferon‑alpha and thymosin‑alpha‑1 injections. About 60% cleared the virus from their blood, many normalised liver enzymes, and some even lost the surface antigen, all without serious side effects. The results look promising but need larger, controlled studies.

Abstract

This open label study was initiated to assess the safety and efficacy of lymphoblastoid interferon-alpha (IFN-alpha) and thymosin alpha 1 (T alpha 1) in the treatment of 11 patients with chronic hepatitis B, who had failed to respond to standard IFN-alpha 2b therapy, and in four interferon naive patients. These fifteen hepatitis B surface antigen (HBsAg) positive and serum hepatitis B virus (HBV) DNA positive patients were given T alpha 1 (1 mg) subcutaneously (s.c.) on 4 consecutive days. Low-dose lymphoblastoid IFN-alpha (3 MU) was administered intramuscularly (i.m.) on the fourth day. Beginning with the second and for the subsequent 25 weeks, patients self-administered T alpha 1 twice weekly in the morning followed, 12 h later, by 3 million units (MU) lymphoblastoid IFN-alpha. Patients were followed-up for 12 months. Nine (60%) of the 15 patients, including six (55%) of the 11 patients previously treated with IFN-alpha 2b, responded by losing serum HBV DNA and normalizing alanine aminotransferase (ALT) values. Six of the nine responders seroconverted to HBsAg negativity. Significant improvements in the Knodell histological activity index were observed in the responders and no significant adverse effects were observed. Combination low-dose lymphoblastoid IFN-alpha and T alpha 1 treatment may provide a safe and potentially effective therapeutic approach in chronic hepatitis B. These results require confirmation in future randomized controlled studies.

Study Information

Provider

pubmed

Year

1996

Date

1996-07-01T00:00:00.000Z

DOI

10.1111/j.1365-2893.1996.tb00094.x

Citations

60

References

20