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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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( Young-Suk Lim ),( Henry Lik Yuen Chan ),( Wai-Kay Seto ),( Qing Ning ),( Kosh Agarwal ),( Harry L. A. Janssen ),( Calvin Q. Pan ),( Wan Long Chuang ),( Namiki Izumi ),( Scott K Fung ),( Dr Shalimar 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1
Aims: Potent antiviral treatment can reduce HCC incidence in CHB patients. TAF has shown antiviral efficacy similar to TDF, with higher rates of ALT normalization and no resistance in Phase 3 studies. We evaluated the impact of TAF or TDF on HCC in the ongoing Phase 3 studies. Methods: HBeAg-positive (n=1039) and -negative (n=593) patients with HBV DNA≥20,000 IU/mL and ALT >60 U/L (males) or >38 U/L (females) were recruited from 190 sites in 20 countries and randomized (2:1) to TAF or TDF. HCC was assessed at 6-monthly intervals by hepatic ultrasonography introduced after Week 96 and throughout by local standards of care. The standardized incidence ratio (SIR) for HCC was calculated for observed cases relative to predicted risk using the REACH-B model. Results: Through 5 years of follow-up, HCC occurred in 21 patients (1.0% [11/1,093] with TAF, 1.9% [10/539] with TDF). Median (Q1, Q3) time to HCC onset was 104 (55, 191) weeks. At baseline, relative to those without HCC, patients with HCC were more likely to be older (median age 53 vs 39y; P<0.001), male (90% vs 65%; P=0.014), and cirrhotic (FibroTest ³0.75; 33% vs 9%; P<0.001). The overall SIR was significantly reduced with TAF or TDF (SIR 0.42, 95% CI 0.27-0.64). HCC incidence was significantly reduced in noncirrhotic patients (SIR 0.37, 95% CI 0.22 to 0.63), and in patients receiving TAF (SIR 0.35, 95% CI 0.19-0.62). Lack of ALT normalization at Week 24 (HR 6.90; P=0.011), cirrhosis (HR 4.18; P=0.006), baseline HBsAg level (HR 0.53; P=0.006), and baseline hypertension (HR 5.55; P<0.001) were significant predictors of HCC development by multivariable analysis. Conclusions: In CHB patients receiving TAF or TDF, the incidence of HCC was reduced comparing with expected HCC incidence from REACH-B model. In patients treated with TAF, a significant reduction in SIR was seen, whereas those treated with TDF showed a trend toward a reduction.
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