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Alpha interferon and lamivudine combination therapy for chronic hepatitis B in children
Mukadder Ayşe Selimoglu1, Sema Aydogdu, Fatih Unal
1Department of Pediatric Gastroenterology, School of Medicine, Ege University, Izmir, Turkey. ayseselimoglu@hotmail.com
Insights
Combination therapy with alpha interferon (IFN-alpha) and lamivudine showed similar efficacy to IFN-alpha monotherapy in children with chronic hepatitis B. High ALT levels and hepatic activity index predicted treatment response.
Area of Science:
- Hepatology
- Pediatric Gastroenterology
- Virology
Background:
- Chronic hepatitis B (CHB) management in children often requires alternative therapies when alpha interferon (IFN-alpha) monotherapy is insufficient.
- Limited data exists on the efficacy and safety of combining IFN-alpha with lamivudine in pediatric CHB patients.
Purpose of the Study:
- To evaluate the efficacy and safety of combination therapy with IFN-alpha and lamivudine compared to IFN-alpha monotherapy in children with CHB.
- To identify predictors of treatment response in pediatric CHB patients receiving these therapies.
Main Methods:
- A study involving pediatric patients with CHB, divided into two groups: one receiving IFN-alpha and lamivudine (n=47), the other IFN-alpha alone (n=30).
- IFN-alpha was administered subcutaneously thrice weekly for 6 months, while lamivudine was given orally daily for 1 year.
- Clinical examinations, blood counts, serum ALT, amylase, and serological markers were monitored throughout the study period.
Main Results:
- The end-of-therapy response rates were comparable between the combination group (40.4%) and the monotherapy group (46.7%) (P > 0.05).
- In the combination group, higher pretreatment serum ALT and hepatic activity index (HAI) were associated with treatment response (P < 0.005).
- In the monotherapy group, responders had higher mean serum ALT and lower hepatitis B virus (HBV) DNA levels.
Conclusions:
- IFN-alpha and lamivudine combination therapy demonstrated similar response rates to IFN-alpha monotherapy in children with CHB.
- Elevated ALT levels and HAI are significant predictors of treatment response, whereas low HBV DNA levels are not.
- The findings suggest that combination therapy does not offer a significant advantage over monotherapy in this pediatric population, but baseline liver inflammation is a key response predictor.
Background:
Lamivudine is a new alternative therapeutic agent for chronic hepatitis B, in which alpha interferon (IFN-alpha) monotherapy is not successful enough. Published reports have revealed no satisfactory data on IFN-alpha and lamivudine combination therapy in children. The aim of this study is to investigate the efficacy and safety of this combination therapy in children with chronic hepatitis B.
Methods:
Children with chronic hepatitis B were given either IFN-alpha and lamuvidine (group 1, n = 47) or IFN-alpha alone (group 2, n = 30). Alpha interferon was administered as 5 million U/m2 s.c., thrice a week for 6 months and lamivudine 4 mg/kg per day p.o., maximum 100 mg, for 1 year. Clinical examination was performed; blood cell counts and serum alanine aminotransferase (ALT) and amylase were studied at each visit. At the third, sixth and twelfth month, serological markers were determined.
Results:
End of therapy response was achieved in 19 (40.4%) patients in group 1 and in 14 (46.7%) children in group 2 (P > 0.05). In group 1, pretreatment serum ALT and hepatic activity index (HAI) were statistically higher in children who responded to therapy (P < 0.005). In group 2, mean serum ALT was higher and hepatitis B virus (HBV) DNA was lower in responders. Sustained response rate was 40.4 versus 43.3% in two groups.
Conclusion:
The response rate of IFN-alpha and lamivudine combination therapy in children with chronic hepatitis B was similar to that of IFN-alpha monotherapy. High ALT level and HAI, rather than low HBV-DNA level were found to be important predictors of response.