This open label study was initiated to assess the safety and efficacy of lymphoblastoid interferon-α (IFN-α) and thymosin α1 (Tα1) in the treatment of 11 patients with chronic hepatitis B, who had failed to respond to standard IFN-α2b 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 Tα1 (1 mg) subcutaneously (sc) on 4 consecutive days. Low-dose lymphoblastoid IFN-α (3 MU) was administered intramuscularly (IM) on the fourth day. Beginning with the second and for the subsequent 25 weeks, patients self-administered Tα1 twice weekly in the morning followed, 12 h later, by 3 million units (MU) lymphoblastoid IFN-α. Patients were followed-up for 12 months. Nine (60%) of the 15 patients, including six (55%) of the 11 patients previously treated with IFN-α2b, 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-α and Tα1 treatment may provide a safe and potentially effective therapeutic approach in chronic hepatitis B. These results require confirmation in future randomized controlled studies. © 1996 Blackwell Science Ltd.

Rasi, G., Mutchnick, M.G., Di Virgilio, D., Sinibaldi Vallebona, P., Pierimarchi, P., Colella, F., et al. (1996). Combination low-dose lymphoblastoid interferon and thymosin α1 therapy in the treatment of chronic hepatitis B. JOURNAL OF VIRAL HEPATITIS, 3(4), 191-196.

Combination low-dose lymphoblastoid interferon and thymosin α1 therapy in the treatment of chronic hepatitis B

Rasi, G;SINIBALDI VALLEBONA, PAOLA;FAVALLI, CARTESIO;GARACI, ENRICO
1996

Abstract

This open label study was initiated to assess the safety and efficacy of lymphoblastoid interferon-α (IFN-α) and thymosin α1 (Tα1) in the treatment of 11 patients with chronic hepatitis B, who had failed to respond to standard IFN-α2b 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 Tα1 (1 mg) subcutaneously (sc) on 4 consecutive days. Low-dose lymphoblastoid IFN-α (3 MU) was administered intramuscularly (IM) on the fourth day. Beginning with the second and for the subsequent 25 weeks, patients self-administered Tα1 twice weekly in the morning followed, 12 h later, by 3 million units (MU) lymphoblastoid IFN-α. Patients were followed-up for 12 months. Nine (60%) of the 15 patients, including six (55%) of the 11 patients previously treated with IFN-α2b, 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-α and Tα1 treatment may provide a safe and potentially effective therapeutic approach in chronic hepatitis B. These results require confirmation in future randomized controlled studies. © 1996 Blackwell Science Ltd.
Pubblicato
Rilevanza internazionale
Articolo
Sì, ma tipo non specificato
Settore MED/07 - Microbiologia e Microbiologia Clinica
English
Con Impact Factor ISI
Lymphoblastoid interferon; Thymosin α1, chronic hepatitis b
Rasi, G., Mutchnick, M.G., Di Virgilio, D., Sinibaldi Vallebona, P., Pierimarchi, P., Colella, F., et al. (1996). Combination low-dose lymphoblastoid interferon and thymosin α1 therapy in the treatment of chronic hepatitis B. JOURNAL OF VIRAL HEPATITIS, 3(4), 191-196.
Rasi, G; Mutchnick, M; Di Virgilio, D; SINIBALDI VALLEBONA, P; Pierimarchi, P; Colella, F; Favalli, C; Garaci, E
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/50907
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