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A randomized controlled trial of thymosin‐α 1 versus interferon alfa treatment in patients with hepatitis B e antigen antibody—and hepatitis B virus DNA—positive chronic hepatitis B
Author(s) -
Andreone P,
Cursaro C,
Gramenzi A,
Zavaglia C,
Rezakovic I,
Altomare E,
Severini R,
Franzone J S,
Albano O,
Ideo G,
Bernardi M,
Gasbarrini G
Publication year - 1996
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.510240404
Subject(s) - medicine , gastroenterology , hbeag , interferon alfa , immunology , hepatitis b virus , hepatitis b , thymosin , hepatitis , alpha interferon , alanine transaminase , antibody , interferon , virus , hbsag
It has recently been shown that thymosin‐α 1 (T‐α 1 ), a synthetic polypeptide of thymic origin, is able to promote disease remission and inhibition of hepatitis B virus (HBV) replication in patients affected by hepatitis B e antigen (HBeAg)‐positive chronic active hepatitis. We evaluated the efficacy and safety of T‐α 1 treatment in patients with hepatitis B e antibody (anti‐HBe) and HBV‐DNA‐positive chronic hepatitis. Thirty‐three patients were randomly assigned to receive either T‐α 1 900 microg/m 2 body surface area twice weekly (17 patients) or 5 MU of interferon alfa (IFN‐α) three times weekly (16 patients) for 6 months. At baseline, both groups were comparable concerning age, sex, liver histology, and alanine transaminase (ALT) levels. At the end of treatment, complete response (defined as ALT normalization and HBV‐DNA loss) occurred in 5 of 17 (29.4%) in the T‐α 1 group and in 7 of 16 (43.8%) in the IFN‐α group ( P = not significant). After a follow‐up period of 6 months, a complete response was observed in 7 of 17 (41.2%) in the T‐α 1 group and in 4 of 16 (25%) in the IFN‐α group ( P = n.s.). Compared with the results observed in a group of 15 patients never treated with IFN‐α and followed for 12 months, the rate of complete response was significantly higher in the IFN‐α group at the end of therapy (1 of 15 vs. 7 of 16, respectively; P < .05) and in the T‐α 1 group at the end of follow‐up (1 of 15 vs. 7 of 17, respectively; P < .05). Unlike IFN‐ α, T‐α 1 was well tolerated by all patients. The only side effect, reported by some, was local discomfort at injection sites. The results of this trial suggest that T‐α 1 is able to reduce HBV replication in patients affected by anti‐HBe‐positive chronic hepatitis. Furthermore, compared with IFN‐α, T‐α 1 is better tolerated and seems to induce a gradual and more sustained ALT normalization and HBV‐DNA loss. In conclusion, T‐α 1 appears to be a safe and effective alternative treatment for anti‐HBe‐positive chronic hepatitis. The benefit of this agent in producing long‐term inhibition of HBV replication must be confirmed by future trials.