Thymosin-alpha 1 plus interferon-alpha for naive patients with chronic hepatitis C: results of a randomized controlled pilot trial.
Andreone. P P; Gramenzi. A A; Cursaro. C C; Felline. F F; Loggi. E E; D'Errico. A A; Spinosa. M M; Lorenzini. S S; Biselli. M M; Bernardi. M M
Key Findings
- Combination of interferon‑alpha and thymosin‑alpha‑1 gave a higher end‑of‑treatment virological response (p=0.03).
- Sustained biochemical and virological responses at 6‑month follow‑up were similar between groups.
- Study was a pilot with only 41 participants, suggesting larger trials are needed.
Practical Outcomes
- For people with chronic hepatitis C, adding thymosin‑alpha‑1 may speed up early virus clearance, but current evidence doesn’t show a lasting cure benefit. It’s not ready for routine use, and larger, longer studies are required before it can be recommended as a standard supplement to interferon therapy.
Summary
A small study found that adding the immune‑boosting peptide thymosin‑alpha‑1 to standard interferon therapy helped more hepatitis C patients clear the virus by the end of treatment, but the benefit disappeared after six months, so it didn’t improve the long‑term cure rate.
Abstract
In this pilot study, we evaluated the efficacy of interferon-alpha (IFN) plus Thymosin-alpha 1 (TA1) to that of IFN alone in naive patients with chronic hepatitis C. Twenty-two patients were randomized to receive interferon-alpha 2b (3 million units three times a week) plus thymosin-alpha l (900 microg/m2 body surface area) and 19 received interferon-alpha 2b alone at the same dose. Patients were treated for 6 months and followed up for another 6 months. Biochemical (alanine aminotransferase values) and virological (hepatitis C virus-RNA) responses to treatment were determined. Combination treatment showed significantly higher efficacy than monotherapy in achieving virological end-of-treatment response (P = 0.03). At 6-month follow up, the sustained biochemical and virological response was not different between the two groups. Our results indicate that the immune modulator TA1 may enhance the end-of-treatment response in naive patients with chronic hepatitis C. Higher doses and/ore more prolonged courses as well as the association with new interferon formulation such as pegylated interferons could improve the sustained response rates to this treatment.
Study Information
pubmed
2004
2004-01-01T00:00:00.000Z
10.1046/j.1365-2893.2003.00470.x
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