A controlled study of treatment with recombinant interferon
alpha in chronic hepatitis B virus infection: induction and maintenance
schedules.
Carreño V, Porres JC, Mora I, Gútiez J, Quiroga JA, Ramón y Cajal S, Oliva H,
Compernolle C, Bartolomé J.
Department of Gastroenterology, Fundacion Jimenez Diaz, Madrid, Spain.
To determine the antiviral effect of recombinant-interferon (rIFN)-alpha in
hepatitis B virus (HBV) chronic infection, a controlled study was carried out. A
total of 20 HBsAg chronic carriers (18 chronic active hepatitis and 2 chronic
persistent hepatitis) were included. All of them had remained HBeAg, HBV-DNA and
HBV-DNA polymerase (HBV-DNAp) positive at least six months before treatment. The
patients were randomly assigned to two groups: control (n = 10), and treatment
(n = 10). A dose of 5.5 megaunits of rIFN-alpha/m2 body surface was administered
every day for 21 days (induction) and twice a week for six months thereafter (maintenance).
No basal differences were observed between the two groups. No case of
intolerable toxicity was observed. One treated patient died in a car crash in
the second month. At the end of the first week of therapy, 7/10 (70%) of the
treated patients became HBV-DNAp negative. However, in the fifth month only 2
patients remained HBV-DNAp negative and also became HBV-DNA and HBeAg negative.
In contrast, no changes in viral markers among control cases were observed. In
conclusion, rIFN-alpha has an antiviral effect on chronic HBV infection; however,
the induction plus maintenance schedule is not useful to obtain a permanent
effect.
Publication Types:
- Clinical Trial
- Randomized Controlled Trial