Genotype B and younger patient age associated with better response to low-dose therapy: a trial with pegylated/nonpegylated interferon-alpha-2b for hepatitis B e antigen-positive patients with chronic hepatitis B in China.
BACKGROUND
Cost and clinically significant adverse effects are the major limiting factors of interferon (IFN) use in therapy for chronic hepatitis B virus (HBV) infection. A clinical trial was conducted in China to study the efficiency and clinical relevance of low-dose regimen of IFN treatment for chronic HBV infection and to reveal factors predicting sustained combined response.


METHODS
During a randomized, open-label control study, hepatitis B e antigen (HBeAg)-positive patients with chronic HBV infection (n=230) were assigned to receive pegylated IFN- alpha -2b (1.0 micro g/kg) (n=115) or IFN- alpha -2b (3 MIU; n=115) for a 24-week period. Sustained combined response was assessed 24 weeks after the completion of treatment.


RESULTS
The greater rate of HBeAg loss in the pegylated IFN-group (23%) was the only statistically significant difference between the 2 treatment arms observed at the end of follow-up. The results of the multivariate statistical analysis revealed that HBV genotype B and patient age (< or =25 years) were 2 independent factors associated with sustained combined response. A total of 40% of patients with HBV genotype B aged < or =25-years achieved sustained combined response. Only 4 (1.7%) of 230 patients discontinued therapy because of clinically significant adverse effects.


CONCLUSIONS
The choice of low-dose IFN regimen might be a relevant clinical option to reduce the cost and adverse effects of therapy for younger patients with chronic HBV infection and genotype B infection in countries where it is prevalent.
Zhao
Hong
H
Peking University First Hospital, Beijing 100034, China.
Kurbanov
Fuat
F
Wan
Mo-Bin
MB
Yin
You-Kuan
YK
Niu
Jun-Qi
JQ
Hou
Jin-Lin
JL
Wei
Lai
L
Wang
Gui-Qiang
GQ
Tanaka
Yasuhito
Y
Mizokami
Masashi
M
Si
Chong-Wen
CW
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000704:Analysis of Variance; D000998:Antiviral Agents / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical; D002681:China; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D006513:Hepatitis B e Antigens / Q000276:immunology*; D006515:Hepatitis B virus / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000276:immunology*; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011237:Predictive Value of Tests; D011336:Probability; D011994:Recombinant Proteins; D012720:Severity of Illness Index; D016896:Treatment Outcome; D019562:Viral Load
D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b