<http://onlinelibrary.wiley.com/doi/10.1002/hep.24555/abstract>
HBV基因型B型或C, 更短的持续时间与低剂量的聚乙二醇干扰素α-2a
关系到伪劣HBeAg的血清转换率.
Shorter durations and lower doses of peginterferon alfa-2a are associated
with inferior HBeAg seroconversion rates in HBV genotypes B or C
Y-F Liaw1,*,?, J-D Jia2, HLY Chan3, KH Han4, T Tanwandee5, WL Chuang6, D
Tan7, XY Chen8, E Gane9, T Piratvisuth10, L Chen11, Q Xie12, JJY Sung3, C
Wat13, C Bernaards14, Y Cui15, P Marcellin16DOI: 10.1002/hep.24555
Abstract
As there is currently a lack of consensus on the most appropriate dose and
duration of peginterferon alfa-2a (PEG-IFNα-2a) therapy in hepatitis B e
antigen (HBeAg)-positive patients, the efficacy and safety of either 24 or
48 weeks' duration and 90μg/week or 180μg/week doses were compared.
HBeAg-positive patients (n=544; 34% genotype B, 51% genotype C) were
randomized to receive PEG-IFNα-2a (2x2 factorial design) for 24 or 48
weeks and at 90 μg/week or 180 μg/week and included in the per protocol
population. The primary efficacy endpoint of the non-inferiority study was
HBeAg seroconversion 6 months post-treatment. The prespecified odds ratio
(OR) non-inferiority margin was 1.88 with a one-sided significance level of
0.025. The highest rates of HBeAg seroconversion 6 months post-treatment
were in the 180/48 arm (36.2% versus 14.1%-25.8% in the other arms). When
the dose and duration arms were pooled, the OR for non-inferiority of 24
weeks versus 48 weeks was 2.17 (95% confidence interval [CI] 1.43, 3.31; P=
0.749) and for 90 μg versus 180 μg was 1.79 (95% CI 1.18, 2.72; P=0.410).
As the upper limit of the 95% CI of the ORs were >1.88, 24 weeks were
inferior to 48 weeks and 90μg/week was inferior to 180μg/week. Highest
rates of response in the 180/48 arm were achieved by patients with HBsAg
<1500 IU/mL at Week 12 (58%) or Week 24 (57%), whilst patients with HBsAg
> 20,000 IU/mL did not respond. Adverse events were typical of those
> associated with PEG-IFNα-2a.
Conclusions:
Compared with lower doses and shorter durations, the licensed PEG-IFNα-2a
treatment regimen (180μg/48 weeks) was the most efficacious and beneficial
for HBeAg-positive patients predominantly infected with HBV genotype B or
C. (HEPATOLOGY 2011.)
