[An open-label pilot study evaluating the efficacy and safety of peginterferon alfa-2a combined with ribavirin in children with chronic hepatitis C].
OBJECTIVE
To evaluate the efficacy and safety of peginterferon alfa-2a plus ribavirin in the treatment of children with chronic hepatitis C (CHC) in China.


METHODS
Totally 54 children with CHC were treated with peginterferon alfa-2a plus ribavirin from July 2003 to July 2004. The dose of peginterferon alfa-2a was 104 microg.(m2)-1 per week. An inductive treatment with interferon 1-3 MIU q.o.d for a week was given before peginterferon for the reduction of possible side effects. Initially 1/3 to 1/2 dose of ribavirin was given and then the was gradually increased to an ideal level of 15-20 mg.kg(-1).d(-1).


RESULTS
The mean age of the patients was 11.3 years. Twenty three patients (42.6%) had received interferon plus ribavirin but the disease relapsed or did not respond to the treatment. The HCV of 70.8 percent of patients was genotype 1 and 14.8 percent of patients had a high viral load (>/=10(-6)/L). After 3-month treatment, 87.5% (42/48) and 8.3% (4/48) of the patients became HCV RNA negative or the viral load reduced by >/= 2 log, respectively, and only 8.3% (4/48) of the patients failed to respond. After 6-month treatment, 87.9% (29/33) and 6.1% (2/33) of the patients became HCV RNA negative or had a >/= 2 log reduction of HCV RNA, respectively, and only 6.1% (2/33) failed to respond. The adverse events were the typical of those reported in the treatment with interferon and ribavirin. Pyrexia occurred in 48.1% of patients, fatigue in 46.3%, decreased appetite in 9.3%, and skin rash in 3.7%. The absolute neutrophil counts of 51 patients (94.4%) were reduced to </= 2.0 x 10(-9)/L, and in 35.2% of them to < 1.0 x 10(-9)/L. Hemoglobin were reduced in only 2 patients (in one case to < 100 g/L, and in the other to < 110 g/L).


CONCLUSIONS
The regimen consisted of peginterferon alfa-2a and ribavirin achieved a high virologic response in Chinese children patients with chronic hepatitis C. No severe adverse events occurred and most of the patients well tolerated the treatment.
Zhang
Hong-fei
HF
Department of Pediatric Liver Diseases, The No. 302 Hospital of the People's Liberation Army, Beijing 100039, China.
Yang
Xiao-jin
XJ
Zhu
Shi-shu
SS
Dong
Yi
Y
Chen
Do-wei
DW
Jia
Wen-zheng
WZ
Xu
Zhi-qiang
ZQ
Mao
Yuan-li
YL
Tang
Hong-mei
HM
D000998:Antiviral Agents / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D006515:Hepatitis B virus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D010865:Pilot Projects; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a