Yuming Wang
Southwest Hospital, China
Title: A randomly controlled study comparing efficacy among three combination therapies with different pegylated interferon alfa plus nucleot(s)ide analogues in NUCs-treated HBeAg-positive CHB patients
Biography
Biography: Yuming Wang
Abstract
Adding pegylated interferon alfa in HBeAg-positive CHB patients treated with long-term nucleot(s)ide analogues (NUCs) therapy has demonstrated obvious improvement in HBeAg seroconversion [1,2] and HBsAg loss or seroconversion.[3,4] Thus, it was reported to improve efficacy by adding PEG IFN α in NUC-treated patients.
Aim
This study was to compare response rates of three different pegylated interferon alfa combined with NUCs in NUC-treated HBeAg-positive patients.
Material and Methods
HBeAg-positive CHB patients that achieved HBsAg ≤1000IU/mL, HBeAg ≤5 S/COI and HBeAb ≤2 S/COI after a long-term NUCs treatment (≥2years), were randomized to receive combination therapies of PEG IFN α and NUCs for 24 weeks. Satisfactory response (virological and biochemical response, plus anti-HBe seroconversion) was defined as primary endpoint, ideal response (HBsAg loss) was defined as secondary endpoint. All patients with/without withdrawing drugs were keeping further followed up.
Results
Totally, 105 NUC-treated HBeAg-positive CHB patients with HBV markers fulfilling above-mentioned criteria were enrolled and randomized to receive 40kD PEG IFN-α-2a+NUCs combination therapy (180μg/week, Group A, n=38), 12kD PEG IFN-α-2b +NUCs combination therapy (80μg/week, Group B, n=35), or 40kD PEG IFN-α-2b +NUCs combination therapy (180μg/week, Group C, n=32). There were no signiï¬cant differences in sex, age, HBV genotype and ALT level among the three groups (P>0.05). Satisfactory response rate in Group C (26.3%,10/38)was slightly higherthan in Group A (22.8%, 8/35, P=0.7320)and Group B (31.2%, 10/32, P=0.6489). 40kD PEG IFN-α-2b +NUCs combination therapy achieved significantly higher ideal response rates (18.8%, 6/32) than Group A (5.26%, 2/38, P=0.0773) and Group B (2.86%, 1/35,P=0.0336).(P<0.05).
Conclusion
In NUCs-treated HBeAg-positive CHB patients with low level of HBsAg and HBeAg/HBeAb, our result showed that ideal response rate in 40kD PEG IFN-α-2b +NUCs combination group was higher than in 40kD PEG IFN-α-2a +NUCs and 12kD PEG IFN-α-2b +NUCs combination therapies.
Table. Responses in three groups after treatment for 24 weeks
|
response |
Group A 40kD PEG IFN-α-2a+NUCs (n=38) |
Group B 12kD PEG IFN α-2b+NUCs(n=35) |
Group C 40kD PEG IFN-α-2b +NUCs (n=32) |
P value |
|
Satisfactory response |
10 (26.3%) |
8 (22.8%) |
10 (31.2%) |
C vs. A P=0.7320,C vs. B P=0.6489 |
|
Ideal response |
2 (5.26%) |
1 (2.86%) |
6 (18.8%) |
C vs. A P=0.0773, C vs.B P=0.0336 |