[A multicenter, randomized, open-label study of the safety and effectiveness of pegylated interferon alpha 2b and interferon alpha 2b in treating HBeAg positive chronic hepatitis B patients].
OBJECTIVE
To compare the efficacy and safety of PEG-IFNalpha-2b (Peg-Intron) with IFNalpha-2b (Intron A) in treating HBeAg positive chronic hepatitis B patients.


METHODS
Two hundred thirty chronic hepatitis B (CHB) patients eligible to the following criteria were enrolled into this study: HBsAg and HBeAg(Abbott kit) positive for at least 6 months, serum HBV DNA > or =10(5) copies/ml (real time PCR, LLQ <10(3) copies/ml) and ALT > or =2 x ULN. After 1:1 randomization, the patients received PegIntron (group A: 1.0 microg/kg body weight, SC, once a week) or Intron A (group B: 3 MIU SC, three times a week) for 24 weeks, and followed up for 24 weeks.


RESULTS
(1) In groups A and B, respectively, 80.87% and 83.48% were males; their median ages were 31.0 and 32.0 years old; their median body weights were 65.6 and 65.5 kg; mean serum HBV DNA loads were 8.06 log10 and 7.99 log10; their mean ALT values were 4.17 x ULN and 3.77 x ULN. All of the above parameters between the two groups had no statistically significance differences. (2) At the end of treatment and after follow-up, compared to the Intron A group, the PegIntron group showed better response (including complete and partial response rate, HBV DNA undetectable rate, HBeAg seroconversion rate), but the differences of all of them had no statistical significance. The rate of HBeAg loss was higher in patients receiving PegIntron after follow-up (P = 0.0424). (Table 2) (3) PegIntron and Intron A reduced serum HBV DAN persistently during the therapy. Mean reduction at the end of the treatment was much higher in the PegIntron group than in the Intron group (2.22 log10 copies/ml vs 1.66 log10 copies/ml, P = 0.0283). (4) The overall incidence of adverse events (AEs) in the PegIntron group was similar to that of the Intron A group (94.78% vs 95.65%). The AEs associated with PegIntron administration were similar in nature to those with Interon A, such as influenza-like symptoms, fever, fatigue, headache, nausea, etc and the differences of their incidences had no statistical significance.


CONCLUSIONS
The efficacy and safety of PEG-IFNalpha-2b treatment for CHB patients seems to be better than that of IFNalpha-2b; however, further studies are needed to confirm it.
Zhao
Hong
H
First Hospital, Beijing University, Beijing 100034, China. minmin2001@126.com
Si
Chong-wen
CW
Wei
Lai
L
Wan
Mo-bin
MB
Ying
You-kuan
YK
Hou
Jin-lin
JL
Niu
Jun-qi
JQ
D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011994:Recombinant Proteins
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