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本帖最后由 StephenW 于 2016-10-9 18:02 编辑
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Change of HBsAg quantity and its relation with HBeAg
seroconversion following 48 weeks pegylated-interferon-
alpha treatment in HBeAg positive chronic hepatitis
B patients after long term nucleos(t)ide analogue maintenance
therapy (Roll Over trial) : Interim analysis at 48
weeks
Hyun Young Woo1, Jeong Heo1, Won Young Tak2, Heon Ju Lee3,
Woo Jin Chung4, Soo Young Park2, Won Lim1, Young Mi Hong1,
Ki Tae Yoon1, Young-Oh Kweon2, Mong Cho1; 1Department of
Internal Medicine, College of Medicine, Pusan National University,
Busan, Korea (the Republic of); 2Department of Internal Medicine,
College of Medicine, Kyungpook National University, Daegu,
Korea (the Republic of); 3Department of Internal Medicine, Yeungnam
University College of Medicine, Daegu, Korea (the Republic
of); 4Department of Internal Medicine, Keimyung University School
of Medicine, Daegu, Korea (the Republic of)
Purposes: Durable post-treatment response is uncommon in
chronic hepatitis B (CHB) patients on nucleos(t)ide analogue
therapy. The aim of this study is to investigate Pegylated interferon
after long term nucleos(t)ide analogue (NA) therapy
might potentiate the antiviral efficacy directly via its effect on
broad antiviral activities and indirectly via activation of innate
and adaptive immune responses leading to HBeAg seroconversion
and eventually HBsAg loss and/or seroconversion. Methods:
Hepatitis B e antigen (HBeAg)-positive CHB patients who
had been treated with any nucleos(t)ide analogue, who have
an undetectable HBV DNA (<80 IU/ml) at least 1 year, were
randomised 1:1 to receive peginterferon alfa-2a 180 lg/week
or previous nucleos(t)ides for 48 weeks. The primary endpoint
was change in log10 HBsAg titer during antiviral therapy (ClinicalTrials.
gov: NCT01769833). Interim analysis was performed
after 48 weeks of treatment. Results: Until interim analysis, 126
patients were randomised; Four patients were excluded due
to screen failure. 89 finished 48 weeks of treatment and 50
received P1 study drug dose. On 48 week, on treatment HBsAg
decline was significantly higher in patients who switched to
peginterferon alfa-2a than those who continued nucleos(t)ides
(mean log HBsAg ±S.D, 0.3022±0.472 vs. 0.014±0.297;
p < 0.001). Until week 48, only patients receiving peginterferon
alfa-2a achieved HBeAg seroconversion [26% (13/50)
vs 0% (0/39); p = 0.002]. HBsAg loss was not observed in
both groups. On-treatment HBV DNA elevation rate (more than
2000 IU/mL) was significantly higher in patients who switched
to peginterferon alfa-2a than those who continued nucldeos(t)
ides [24% (12/50) vs 0% (0/39); p = 0.001). However, none
of these on treatment HBV DNA elevation was accompanied
by significant alanine aminotransferase elevation. Only treatment
with peginterferon alfa-2a was significantly associatged
with HBeAg seroconversion (p=0.001). Peginterferon alfa-2a
was well-tolerated. Conclusions: This interim analysis showed
that, for patients who achieve virological suppression with oral
nucleos(t)ides but remain HBeAg positive, switching to a 48
weeks of peginterferon alfa-2a significantly decrease HBsAg
titer and increases rates of HBeAg seroconversion.
Disclosures:
Jeong Heo - Advisory Committees or Review Panels: Abbvie, Gilead; Grant/
Research Support: BMS, Roche, GSK, Sillajen
Won Young Tak - Advisory Committees or Review Panels: Gilead Korea; Grant/
Research Support: SAMIL Pharma
The following people have nothing to disclose: Hyun Young Woo, Heon Ju Lee,
Woo Jin Chung, Soo Young Park, Won Lim, Young Mi Hong, Ki Tae Yoon,
Young-Oh Kweon, Mong Cho
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发表于 2016-10-9 17:57