title: Comparison of two different regimens of combined interferon-alpha2a and lamivudine therapy in children with chronic hepatitis B infection.
abstract: OBJECTIVE
  To evaluate the efficacy of two regimens of combined interferon-alpha2a (IFN-alpha2a) and lamivudine (3TC) therapy in childhood chronic hepatitis B.
  
  
  METHODS
  A total of 177 patients received IFN-alpha2a, 9 million units (MU)/m2 for 6 months. In group I (112 patients, 8.7 +/- 3.5 years), 3TC (4 mg/kg/day, max 100 mg) was started simultaneously with IFN-alpha2a, in group II (65 patients, 9.6 +/- 3.8 years) 3TC was started 2 months prior to IFN-alpha2a. 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; and 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.
  
  
  CONCLUSIONS
  Simultaneous 3TC+IFN-alpha2a 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.
authors.affiliation: Department of Pediatric Gastroenterology, Hepatology and Nutrition, Akdeniz University School of Medicine, Antalya, Turkey. aydankansu@gmail.com
authors.forename: Aydan
authors.initials: A
authors.lastname: Kansu
authors.forename: Tümay
authors.initials: T
authors.lastname: Doğanci
authors.forename: Sezin A
authors.initials: SA
authors.lastname: Akman
authors.forename: Reha
authors.initials: R
authors.lastname: Artan
authors.forename: Necdet
authors.initials: N
authors.lastname: Kuyucu
authors.forename: Ayhan Gazi
authors.initials: AG
authors.lastname: Kalayci
authors.forename: Bünyamin
authors.initials: B
authors.lastname: Dikici
authors.forename: Buket
authors.initials: B
authors.lastname: Dalgiç
authors.forename: Ayşe
authors.initials: A
authors.lastname: Selimoğlu
authors.forename: Erhun
authors.initials: E
authors.lastname: Kasirga
authors.forename: Tanju B
authors.initials: TB
authors.lastname: Ozkan
authors.forename: Zarife
authors.initials: Z
authors.lastname: Kuloğlu
authors.forename: Sema
authors.initials: S
authors.lastname: Aydoğdu
authors.forename: Mehmet
authors.initials: M
authors.lastname: Boşnak
authors.forename: Vildan
authors.initials: V
authors.lastname: Ertekin
authors.forename: Gönül
authors.initials: G
authors.lastname: Tanir
authors.forename: Kenan
authors.initials: K
authors.lastname: Haspolat
authors.forename: Nurten
authors.initials: N
authors.lastname: Girgin
authors.forename: Raşit Vural
authors.initials: RV
authors.lastname: Yağci
mesh_terms: D000293:Adolescent; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004279:DNA, Viral / Q000097:blood; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D011994:Recombinant Proteins; D012738:Sex Hormone-Binding Globulin; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012738:Sex Hormone-Binding Globulin; D019259:Lamivudine; D000410:Alanine Transaminase