The IFNs exhibit antiviral and antiproliferative effects; in addition, a-IFN is an immunostimulant. The drug does suppress HBV replication in a small proportion of selected children. Twenty-four percent of children 1 year of age and older treated with 3 MU/m2 subcutaneously t.i.w. times 1 week with escalation up to 6 MU/m2 IFN subcutaneously t.i.w for 16 to 24 weeks achieved loss of HBV DNA and HBeAg at 24 weeks of follow-up as opposed to 10% of untreated control patients. The maximum weekly dosage was 10 MU t.i.w. Forty-one percent of the responders lost HBsAg compared with none of the untreated controls. Thirty-five percent of children with a low baseline HBV DNA (< 100 pg/mL) responded compared with 9% with higher levels of HBV DNA. Only 5% of children who had contracted HBV via maternal-fetal transmission achieved a response compared with 31% of those who acquired HBV via other routes. A meta-analysis of 240 children treated with IFN for chronic HBV infection versus untreated controls demonstrated the following odds ratios: (1) increased HBV clearance (2.2), (2) HBeAg clearance (2.2), and (3) ALT normalization (2.3).
IFN is indicated for the treatment of chronic HBV in children 1 year of age or older who have compensated liver disease. Patients should be without a history of hepatic encephalopathy, variceal bleeding, and ascites; should have a normal serum bilirubin and albumin; < 2 seconds prolongation of prothrombin time; white blood cells > 4000/mm3; and platelets > 150,000/mm3.
At baseline prior to therapy, as well as at weeks 1, 2, 4, 8,12, and 16 of therapy, the following tests should be performed:
1. Complete blood count with platelets
2. Aspartate aminotranferase
4. Alkaline phosphatase
5. Total and direct bilirubin
HBeAg, hepatitis B surface antigen (HbsAg), and HBV DNA should be monitored at the beginning of therapy, at the end of 16 weeks of therapy, as well as at 3 and 6 months after cessation of therapy, because some patients may become virologic responders after discontinuation of therapy. Patients who respond to therapy often develop a flare (transient increase in ALT < 2 times baseline value) 8 to 12 weeks after initiation of therapy (59% of responders versus 35% of nonresponders). IFN can be continued during the flare unless signs of liver failure ensue; patients should be monitored clinically and biochemically every 2 weeks during a flare. Adverse effects include flu-like symptoms, anxiety, depression, anorexia, weight loss, hair loss, bone marrow suppression, thyroid disorders, and auto-antibody induction.
The following dose reduction/stopping rules should be used:
White blood cells
Platelet Granulocytes count
Reduce dose 50% < 1.5 x 109/L < 0.75 x 109/L < 50 x 109/L Permanently < 1.0 x 109/L < 0.5 x 109/L < 25 x 109/L discontinue
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