A controlled trial of human lymphoblastoid interferon in chronic hepatitis B in Italy.
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 m2 three times per week for 6 months) or to serve as untreated controls. After 18 months of follow-up 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.
Saracco
G
G
Dipartimento di Emergenza and Laboratorio Centrale Baldi e Riberi, Ospedale Molinette, Turin, Italy.
Mazzella
G
G
Rosina
F
F
Cancellieri
C
C
Lattore
V
V
Raise
E
E
Rocca
G
G
Giorda
L
L
Verme
G
G
Gasbarrini
G
G
D000293:Adolescent; D000328:Adult; D002986:Clinical Trials as Topic; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D006511:Hepatitis B Antigens / Q000032:analysis; D006521:Hepatitis, Chronic / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D006801:Humans; D007370:Interferon Type I / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011897:Random Allocation; D012737:Sex Factors
D004279:DNA, Viral; D006511:Hepatitis B Antigens; D007370:Interferon Type I