Lymphoblastoid interferon therapy of chronic HBV infection. A comparison of 12 vs. 24 weeks of thrice weekly treatment.

This study set out to examine the relative effectiveness and tolerability of 12- versus 24-week courses of thrice weekly intramuscular lymphoblastoid interferon in the treatment of hepatitis B 'e' antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection, and to identify pretreatment factors predicting the outcome of therapy. Twenty patients were randomised to each treatment group. Treatment was associated with clearance of HBeAg and HBV-DNA in 59% of the 32 male patients, whereas none of the eight women responded (48% overall response rate). This response rate in males is at least three times the recorded spontaneous seroconversion rates in this population. Most of the women (5/8) were of Oriental origin and had minimal disease, factors that may have influenced response. The longer course was poorly tolerated and was therefore no more effective: eight of 20 patients withdrew because of side-effects. Variables associated with response included high AST (aspartate transaminase), short duration of disease and previous history of acute hepatitis. A response to antiviral therapy was accompanied by clinical and biochemical evidence of improvement in liver disease.

RCT Entities:   Population Interventions Outcomes