PMID- 20189674
OWN - NLM
STAT- MEDLINE
DCOM- 20100524
LR  - 20181201
IS  - 1600-0641 (Electronic)
IS  - 0168-8278 (Linking)
VI  - 52
IP  - 4
DP  - 2010 Apr
TI  - High sustained virologic response rates in children with chronic hepatitis C 
      receiving peginterferon alfa-2b plus ribavirin.
PG  - 501-7
LID - 10.1016/j.jhep.2010.01.016 [doi]
AB  - BACKGROUND & AIMS: Pegylated interferon (PEG-IFN) alfa-2b plus ribavirin (RBV) is 
      the standard of care for adults with chronic hepatitis C but was not approved for 
      the treatment of children at the time of this study. The aim of this study was to 
      evaluate the efficacy and safety of PEG-IFN alfa-2b plus RBV in children. 
      METHODS: Children and adolescents ages 3-17 years were treated with PEG-IFN 
      alfa-2b (60microg/m(2)/week) plus RBV (15mg/kg/day). The duration of therapy was 
      24 weeks for genotype (G) 2 and G3 patients with low viral load (<600,000IU/ml) 
      and 48 weeks for G1, G4, and G3 with high viral load (>or=600,000IU/ml). The 
      primary end point was sustained virologic response (SVR), defined as undetectable 
      hepatitis C virus (HCV) RNA 24 weeks after completion of therapy. RESULTS: SVR 
      was attained by 70 (65%) children. Genotype was the main predictor of response: 
      G1, 53%; G2/3, 93%; G4, 80%. SVRs were similar in younger and older children. 
      Baseline viral load was the main predictor of response in the G1 cohort. No new 
      safety signals were identified, and adverse events (AEs) were generally mild or 
      moderate in severity. Dose was modified because of AEs in 25% of children; 1 
      child discontinued because of an AE (thrombocytopenia). No serious AEs related to 
      study drugs were reported. CONCLUSION: Therapy with PEG-IFN alfa-2b plus RBV in 
      children and adolescents with chronic hepatitis C offers favorable efficacy, 
      reduced injection frequency, and an acceptable safety profile.
FAU - Wirth, Stefan
AU  - Wirth S
AD  - Children's Hospital, HELIOS Klinikum Wuppertal, Witten/Herdecke University, 
      Heusnerstrasse 40, Wuppertal, Germany. stefan.wirth@helios-kliniken.de
FAU - Ribes-Koninckx, Carmen
AU  - Ribes-Koninckx C
FAU - Calzado, Maria Angeles
AU  - Calzado MA
FAU - Bortolotti, Flavia
AU  - Bortolotti F
FAU - Zancan, Lucia
AU  - Zancan L
FAU - Jara, Paloma
AU  - Jara P
FAU - Shelton, Mark
AU  - Shelton M
FAU - Kerkar, Nanda
AU  - Kerkar N
FAU - Galoppo, Marcela
AU  - Galoppo M
FAU - Pedreira, Alejandra
AU  - Pedreira A
FAU - Rodriguez-Baez, Norberto
AU  - Rodriguez-Baez N
FAU - Ciocca, Mirta
AU  - Ciocca M
FAU - Lachaux, Alain
AU  - Lachaux A
FAU - Lacaille, Florence
AU  - Lacaille F
FAU - Lang, Thomas
AU  - Lang T
FAU - Kullmer, Ulrike
AU  - Kullmer U
FAU - Huber, Wolf Dietrich
AU  - Huber WD
FAU - Gonzalez, Teresita
AU  - Gonzalez T
FAU - Pollack, Henry
AU  - Pollack H
FAU - Alonso, Estella
AU  - Alonso E
FAU - Broue, Pierre
AU  - Broue P
FAU - Ramakrishna, Jyoti
AU  - Ramakrishna J
FAU - Neigut, Deborah
AU  - Neigut D
FAU - Valle-Segarra, Antonio Del
AU  - Valle-Segarra AD
FAU - Hunter, Bessie
AU  - Hunter B
FAU - Goodman, Zachery
AU  - Goodman Z
FAU - Xu, Christine R
AU  - Xu CR
FAU - Zheng, Hanzhe
AU  - Zheng H
FAU - Noviello, Stephanie
AU  - Noviello S
FAU - Sniukiene, Vilma
AU  - Sniukiene V
FAU - Brass, Clifford
AU  - Brass C
FAU - Albrecht, Janice K
AU  - Albrecht JK
LA  - eng
SI  - ClinicalTrials.gov/NCT00104052
SI  - ClinicalTrials.gov/NCT00761735
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100204
PL  - Netherlands
TA  - J Hepatol
JT  - Journal of hepatology
JID - 8503886
RN  - 0 (Antiviral Agents)
RN  - 0 (Interferon alpha-2)
RN  - 0 (Interferon-alpha)
RN  - 0 (Recombinant Proteins)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 49717AWG6K (Ribavirin)
RN  - G8RGG88B68 (peginterferon alfa-2b)
SB  - IM
CIN - J Hepatol. 2010 Apr;52(4):472-4. PMID: 20185196
MH  - Adolescent
MH  - Antiviral Agents/*administration & dosage/adverse effects/pharmacokinetics
MH  - Body Height
MH  - Body Weight
MH  - Child
MH  - Child Development
MH  - Child, Preschool
MH  - Drug Resistance, Viral/genetics
MH  - Drug Therapy, Combination
MH  - Female
MH  - Genotype
MH  - Hepacivirus/*drug effects/genetics
MH  - Hepatitis C, Chronic/*drug therapy/virology
MH  - Humans
MH  - Interferon alpha-2
MH  - Interferon-alpha/*administration & dosage/adverse effects/pharmacokinetics
MH  - Male
MH  - Polyethylene Glycols/*administration & dosage/adverse effects/pharmacokinetics
MH  - Recombinant Proteins
MH  - Ribavirin/*administration & dosage/adverse effects/pharmacokinetics
MH  - Treatment Outcome
MH  - Viral Load/drug effects
EDAT- 2010/03/02 06:00
MHDA- 2010/05/25 06:00
CRDT- 2010/03/02 06:00
PHST- 2009/07/16 00:00 [received]
PHST- 2009/09/11 00:00 [revised]
PHST- 2009/09/30 00:00 [accepted]
PHST- 2010/03/02 06:00 [entrez]
PHST- 2010/03/02 06:00 [pubmed]
PHST- 2010/05/25 06:00 [medline]
AID - S0168-8278(10)00024-3 [pii]
AID - 10.1016/j.jhep.2010.01.016 [doi]
PST - ppublish
SO  - J Hepatol. 2010 Apr;52(4):501-7. doi: 10.1016/j.jhep.2010.01.016. Epub 2010 Feb 
      4.