https://www.rxlist.com/zadaxin-drug.htm#indications_dosageChronic Hepatitis B ZADAXIN thymosin alpha 1 (thymalfasin) is indicated as a monotherapy or combination therapy with interferon for the treatment of chronic hepatitis B. Pooled analysis of 3 randomized controlled trials comprising 223 patients was performed. Thymosin alpha 1 was administered twice weekly for 6 months. Follow-up assessments were performed at 12 months after completion of treatment (see table). In multiple studies, ZADAXIN (thymalfasin) was shown to have a delayed therapeutic response 12 months or longer after completion of therapy. A transient increase in ALT to more than twice baseline value (flare) can occur during ZADAXIN (thymalfasin) therapy. When ALT flare occurs, ZADAXIN (thymalfasin) should generally be continued unless signs and symptoms of liver failure are observed. Efficacy of Thymosin Alpha 1 Monotherapy for Chronic Hepatitis B
Study Reference | Number of Patients Treatment Groups | Response Rate at 12-months follow up* | US Phase 2
[1,5] | 12 Thymosin alpha 1
(1.6 mg SQ BIW 6 mos.)
8 Placebo | (83%) Thymosin alpha 1
(25%) Placebo | US Phase 3
[2,5] | 50 Thymosin alpha 1
(1.6 mg SQ BIW 6 mos.)
49 Placebo | (24%) Thymosin alpha 1
(12%) Placebo | Taiwan Phase 3
[3,4,5] | 51 Thymosin alpha 1
(1.6 mg SQ BIW 6 mos.)
53 No treatment | (37%) Thymosin alpha 1
(25%) No treatment | Pooled Data
[5] | 113 Thymosin alpha 1
(1.6 mg SQ BIW 6 mos.)
110 Placebo or no treatment | (36%) Thymosin alpha 1
(19%) Placebo or no treatment | *Response rate is defined as the percentage of subjects who were HBV DNA and HBeAg negative at 12-months follow up |
REFERENCES 1. Mutchnick, M.G., Cummings, G.D., Hoofnagle, J.H., and D.A. Shafritz (1992) Thymosin: An innovative approach to the treatment of chronic hepatitis B, in Combination therapies Biological Response Modifiers in the Treatment of Cancer and Infectious Diseases, A.L Goldstein and E. Garaci, Editors. Plenum Publishing Corp: New York. p. 149-156 2. Mutchnick, M.G., Lindsay, K.L., Schiff, E.R., Cummings, G.D., and H.D. Appelman (1995) Thymosin alpha 1 treatment of chronic hepatitis B: a multicenter, randomized, placebo-controlled double blind study Gastroenterology 108(4): p. A1127 3. Lee, S.-D., D.-S. Chen, and Y.-F. Liaw (1997) Multicenter Study of Thymosin Alpha 1 in the Treatment of Chronic Hepatitis B. Data on file. 4. Chien, R.-N., Liaw Y.-F., Chen, T.-C, Yeh, C.-T., and I.-S. Sheen (1998) Efficacy of Thymosin α1 in Patients with Chronic Hepatitis B: A Randomized, Controlled TrialHepatology 27 (5) May 1998: p.1383-1387. 5. Niedzwiecki, D., Luo, D., Finn, D.S., Whiting, G.W., Connelly, J.E., Kumashiro, M., Allen, I.E. and S.D. Ross (1997) The efficacy of thymosin alpha 1 in chronic hepatitis B: a meta-analysis, Data on file. |