Alpha interferon and lamivudine combination therapy for chronic hepatitis B in children.
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.


CONCLUSIONS
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.
Selimoglu
Mukadder Ayşe
MA
Department of Pediatric Gastroenterology, School of Medicine, Ege University, Izmir, Turkey. ayseselimoglu@hotmail.com
Aydogdu
Sema
S
Unal
Fatih
F
Zeytinoglu
Ayşin
A
Yüce
Gül
G
Yagci
Raşit Vural
RV
D000293:Adolescent; D000998:Antiviral Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D019259:Lamivudine / Q000008:administration & dosage*
D000998:Antiviral Agents; D016898:Interferon-alpha; D019259:Lamivudine