Comparison of efficacy and safety of pegylated interferon alfa-2a or adefovir dipivoxil monotherapy with combination therapy in HBeAg positive chronic hepatitis B patients
10.3760/cma.j.issn.1000-6680.2010.04.005
- VernacularTitle:聚乙二醇干扰素α-2a、阿德福韦酯单用及联合应用治疗HBeAg阳性慢性乙型肝炎患者的疗效及安全性比较
- Author:
Feijian AO
;
Weimin MA
;
Boping ZHOU
;
Daqiao ZHOU
;
Yiwen HU
;
Qing HE
;
Wei DAI
;
Cheng XU
;
Yanzhong PENG
;
Lijia CHEN
;
Guangdong TONG
;
Guang NIE
;
Yan LIU
;
Qun FAN
- Publication Type:Journal Article
- Keywords:
Pegylated IFN a-2a;
Adefovir dipivoxil;
Hepatitis B,chronic;
Drug therapy,combination
- From:
Chinese Journal of Infectious Diseases
2010;28(4):214-217
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the clinical efficacy and safety of pegylated interferon α-2a (Peg IFN α-2a) or adefovir dipivoxil(ADV) monotherapy and their combination therapy in HBeAg positive chronic hepatitis B (CHB) patients. Methods An open randomized controlled multicenter clinical trial was performed. One hundred and twenty cases with CHB were divided into 3 groups: Peg IFN α-2a monotherapy (group A), ADV monotherapy (group B) and Peg IFN α-2a plus ADV combination therapy (group C). The virological response (VR), serological response (HBeAg, HBsAg clearance and seroconversion), biochemical response (BR) and sustained response (SR) were tested at week 24 and 48 of therapy and week 48 of follow-up after end of treatment (EOT) for'evaluation of therapeutic effects, safety and drug resistance. The efficacy was compared using X2 test. Results At week 48 of treatment, the VR (HBV DNA ≤500 copy/mL) rates were 36. 8%(14/38), 37. 5%(15/40) and 62. 9% (22/35), respectively in groups A, B and C; that in group C was higher than those in groups A and B (X2 = 4. 933, 4. 801, respectively; both P < 0. 05); HBeAg seroconversion rates in three groups were 44. 7% (17/38), 17. 5% (7/40) and 51. 4% (18/35), respectively. At week 48 of follow-up,SR rates in three groups were 34. 2%(13/38), 15. 0%(6/40) and 48. 6% (17/35), respectively; those in groups C and A were higher than that in group B (X2 = 9. 894,P<0. 01;X2 =3. 903, P<0. 05, respectively). Conclusions VRs at week 24 and 48 of Peg IFN α-2a plus ADV combination therapy are better than Peg IFN α-2a or ADV monotherapy. SRs at week 48 of follow-up after Peg IFN α-2a monotherapy and combination therapy are both better than ADV monotherapy.
