Thymosin treatment of chronic hepatitis B: a placebo-controlled pilot trial.
Mutchnick. M G MG; Appelman. H D HD; Chung. H T HT; Aragona. E E; Gupta. T P TP; Cummings. G D GD; Waggoner. J G JG; Hoofnagle. J H JH; Shafritz. D A DA
Key Findings
- Serum aminotransferase levels improved significantly in thymosin‑treated patients but not in placebo
- 86% of thymosin‑treated patients cleared HBV DNA from serum versus 20% on placebo
- Liver tissue showed fewer replicative HBV DNA forms in treated group
- Peripheral blood lymphocyte, CD3, CD4 counts and interferon‑gamma production increased
- No significant side effects observed
Practical Outcomes
- Thymosin‑alpha‑1 shows promise as an experimental add‑on for chronic hepatitis B, but the evidence is from a very small pilot trial. If you have HBV, you might discuss a twice‑weekly, six‑month course with a knowledgeable clinician, keeping in mind the limited data and need for medical supervision.
Summary
In a tiny study of 12 people with chronic hepatitis B, giving thymosin‑alpha‑1 (or a related mix) twice a week for six months helped most treated patients lower liver enzymes and clear the virus from their blood, while the placebo group saw little change. The treatment also boosted immune cell counts and interferon‑gamma production, with no serious side effects, and the benefits lasted for about two years after stopping the drug.
Abstract
Chronic hepatitis B is a severe and frequently progressive disease. We assessed the safety and efficacy of thymosin fraction 5 and thymosin-alpha 1 in a prospective, placebo-controlled trial in 12 patients with chronic hepatitis B. All patients had histological and biochemical evidence of active liver disease for at least 6 mo before treatment and were positive for serum hepatitis B virus DNA and HBsAg. Seven patients received thymosin fraction 5 or thymosin-alpha 1 and five patients received placebo twice weekly for 6 mo. By the conclusion of the study (1 yr), serum aminotransferase levels had improved significantly in thymosin-treated patients, but not in the placebo group. Six (86%) of the thymosin treated patients and one (20%) patient given placebo cleared hepatitis B virus DNA from serum (p less than 0.04, Fisher's exact test). After treatment, replicative forms of hepatitis B virus DNA were present in the liver specimens of four of five placebo-treated patients but in only one of seven thymosin-treated patients (p less than 0.04, Fisher's exact test). Response to thymosin therapy was associated with significant improvements in peripheral blood lymphocyte and CD3 and CD4 counts and in in vitro production of interferon-gamma over initial values. No significant side effects were observed in patients given thymosin or in placebo-treated patients. Clinical, biochemical and serological improvement in patients responding to thymosin were sustained during 26 +/- 3 mo of follow-up. The results of this pilot trial suggest that thymosin therapy promotes disease remission and cessation of hepatitis B virus replication in patients with chronic viral infection.
Study Information
pubmed
1991