Comparison of Two Different Regimens of Combined Interferon Alfa- 2a (Pegasys) and Lamivudine Therapy in Children with Chronic Hepatitis B

In the current study, investigators evaluated the efficacy of two regimens of combined interferon alfa-2a (IFN alfa-2a) [Pegasys] and lamivudine (3TC) [Epivir-HBV] therapy in children with chronic hepatitis B.

A total of 177 patients received IFN alfa-2a, 9 million units (MU)/m2 for 6 months.

In group I (112 patients), 3TC (4 mg/kg/day, max 100 mg) was started simultaneously with IFN alfa-2a. In group II (65 patients) 3TC was started 2 months prior to IFNalfa-2a.

3TC was continued for 6 months after antiHBe seroconversion or stopped at 24 months in nonresponders.

Results

Baseline alanine aminotransferase (ALT) was 134.2 ±34.1 and 147.0 ±45.3; histological activity index (HAI) was 7.4 ±2.7 and 7.1 ±2.3; and HBV DNA levels were above 2,000 pg/ml in 76% and 66% of patients in groups I and II, respectively (P>0.005).

Complete response was 55.3% and 27.6% in groups I and II, respectively (P<0.01).

AntiHBe seroconversion was higher and earlier, and HBV DNA clearance was earlier in group I (P<0.05).

HBsAg clearance was 12.5% and 4.6% and antiHBs seroconversion was 9.8% and 6.2% in groups I and II, respectively (P>0.05).

Breakthrough occurred in 17.9% and 24.6%; breakthrough times were 15.9 ±4.6 and 14.1 ±5.1 months.

Relapse rates were 6.8% and none in groups I and II, respectively (P>0.05, P>0.05, P>0.05).

Responders had higher HAI (HAI>6) and higher pre-treatment ALT than non-responders.



In conclusion, the authors write, "Simultaneous 3TC+IFN alfa-2a yields a higher response and earlier antiHBe seroconversion and viral clearance than consecutive combined therapy. Relapse rate is low."

"Predictors of response are high basal ALT and high HAI scores."

"3TC can be administered for 24 months without any side effect and breakthrough rate is comparable with previous studies."

05/12/06

Reference
A Kansu, T Doganci, S A Akman, and others. Comparison of two different regimens of combined interferon-alfa2a and lamivudine therapy in children with chronic hepatitis B infection. Antiviral Therapy 11(2): 255-261. 2006.


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