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- 저자 : ( Huy N. Trinh ) (검색결과 1 건)
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( Yoon Jun Kim ),( Young-suk Lim ),( Shalimar ),( Xiaoli Ma ),( Akash Shukla ),( Huy N. Trinh ),( Pietro Andreone ),( Jae-seok Hwang ),( Vithika Suri ),( George Wu ),( Ondrej Podlaha ),( Anuj Gaggar ) 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: HBeAg seroconversion remains an important endpoint for antiviral therapy. We previously reported on HBeAg loss following 48 weeks of oral antiviral therapy in the ongoing phase 3 study described below. Here we present an updated evaluation of factors associated with HBeAg loss with/without anti-HBe seroconversion following 3 years of antiviral therapy. Methods: The study included adults with HBeAg-positive CHB enrolled in a Phase 3 trial(Study GS-US-320-0110) comparing TAF 25mg QD vs. TDF 300mg QD. At Week144, 340(39%; TAF 226; TDF 114) patients had received 1year of open label TAF 25mg QD after switching from double blind(DB) treatment. The associations between HBeAg loss at Week144 with host, viral, and treatment-related factors, including on-treatment virologic suppression, were determined using logistic regression analy ses. Results: Among 873 ipatients, the median age was 36yrs, 82% were Asian, and median baseline (BL) ALT and HBV DNA were 85U/L (IQR 60-138) and 7.9 log10IU/mL (IQR 6.9- 8.6), respectively. At Week144, a total of 194patients (22%) experienced HBeAg loss and 142 patients (16%) underwent HBeAg seroconversion (Figure 1). Compared with subjects with persistent HBeAg-positivity, those with HBeAg loss were older (median age, 35 vs. 40yrs), were infected with non-genotype D HBV (75% vs 86%), had lower median HBsAg levels (4.3 vs 3.8 log10 IU/mL), a higher median BL ALT (83 vs. 101U/L), a higher prevalence of presumed cirrhosis (Fibro Test ≥0.75:6.4% vs. 13.2%), and lower median BL serum HBV DNA (8.1 vs. 7.7 log10 IU/mL) (all P≤0.005). In multivariate analysis, baseline HBV DNA<8 log10 was an independent predictor of both HBeAg loss(OR: 1.816 [1.174-2.808]; P=0.007) and seroconver sion (OR: 2.512 [1.684-3.746]; P<0.001); treatment with TAF in the DB period was a predictor of seroconversion (OR:1.596 [1.044-2.439]; P=0.031) but not loss. Conclusions: Following 144 weeks of treatment, HBeAg loss/ seroconversion rates remains low in subjects treated with TAF or TDF with lower baseline HBV DNA levels associated with higher rates of response.
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