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A controlled trial of human lymphoblastoid interferon in chronic hepatitis B in Italy
Author(s) -
Saracco Giorgio,
Mazzella Giuseppe,
Rosina Floriano,
Cancellieri Claudio,
Lattore Valter,
Raise Enzo,
Rocca Giuseppe,
Giorda Laura,
Verme Giorgio,
Gasbarrini Giovanni,
Barbara Luigi,
Bonino Ferruccio,
Rizzetto Mario,
Roda Enrico
Publication year - 1989
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.1840100315
Subject(s) - medicine , chronic hepatitis , virology , lymphoblast , interferon , immunology , biology , genetics , virus , cell culture
Sixty‐four heterosexual Italian carriers of HBsAg with chronic HBeAg and hepatitis B virus DNA‐positive hepatitis were assigned randomly either to receive human lymphoblastoid interferon (injections of 5 million units per m 2 three times per week for 6 months) or to serve as untreated controls. After 18 months of followup evaluation, 26 of the 33 treated patients (79%) had cleared hepatitis B virus DNA, 23 (70%) had lost HBeAg and 20 (61%) had seroconverted to anti‐HBe. Fifteen of the 31 controls (48%) had cleared hepatitis B virus DNA (p = 0.01), 12 (39%) had lost HBeAg and nine (29%) had seroconverted to anti‐HBe (p = 0.002). Eight treated patients but only one control had lost HBsAg and seroconverted to anti‐HBs (24% vs. 3%, p = 0.01). Treated patients cleared hepatitis B virus markers after a mean interval of 4 months, compared with 8 months in the controls. All responders to interferon cleared intrahepatic HBcAg, and 50% showed histological improvement. The baseline hepatitis B virus DNA levels and the original histology were not predictive of a response to therapy; women appeared to respond better than men. Lymphoblastoid interferon provides an effective therapy in the heterosexual Italian patient with chronic hepatitis B.