Sa1524 — 2020 AASLD FACTORS THAT MAY AFFECT THE CHANGES OF LIVER STIFFNESS MEASUREMENTS ASSESSED BY TRANSIENT ELASTOGRAPHY (TE) IN PATIENTS WITH CHRONIC HEPATITIS B (CHB) ON LONG-TERM THERAPY WITH TENOFOVIR DISOPROXIL FUMARATE (TDF).
Liver Diseases and Transplantation
I04 Therapeutics - Approved Agents
Presented on Saturday, May 2, 2020 12:30 PM Author(s): Hariklia Kranidioti1, Adonis A. Protopapas2, Theodoros Voulgaris3, Chrisostomos Tsolias4, PINELOPI ANTONAKAKI1, Ioanna Segkou1, Melanie Deutsch1, Christos Triantos4, John Goulis2, George Papatheodoridis3, Spilios Manolakopoulos1,3
Background and Aim
Virological remission in CHB patients on long-term TDF monotherapy is associated with an improvement in histology. The aim of this study was to evaluate the fibrosis changes as assessed by TE in a cohort of patients with CHB receiving TDF monotherapy. Methods
We included CHB patients from the REST-B cohort who were treated with TDF for >36 months and had at least 3 Liver Stiffness Measurements (LSM) (baseline and >2 during follow-up). Virological remission was defined by undetectable serum HBV DNA with sensitive PCR assays. Liver fibrosis was assessed with transient TE (Fibroscan®). The cut-off value for advanced fibrosis/cirrhosis was 9 kPa. Results
In total, 107 patients were included. Mean age was 56±13 years old, 59 (55%) were males and 8 (7.5%) were HBeAg positive; median follow-up period was 79 (range: 36-127) months. Virological remission rates were 96% and 98.6%, while ALT was normal (<40 IU/L) in 87% and 90% of patients at 24 and 48 months, respectively. At baseline, 38% of the patients had at least one of the following comorbidities: hypertension, diabetes mellitus, dyslipidemia or BMI>30. Median baseline liver stiffness was 6.8 (range: 3.5-40.5) kPa; 22% of the patients had advanced fibrosis/cirrhosis (mean LSM: 16±13 kPa vs 6.3±1.3 kPa for those without advanced fibrosis). A significant higher LSM was observed in patients with comorbidities (10.7±9 vs 7±3.2 kPa, p=0.04). There was a significant reduction in mean LSM between baseline and 24, 36, 48 months and last visit (8.5±6 vs 7.9±4, 7.5±4, 7±4, 7.5±5 kPa, respectively; p<0.001). At the last visit, 20% of the patients had >3 kPa decrease in LSM compared to baseline. The mean reduction of LSM was higher in patients with than without advanced fibrosis at baseline (4.9 vs 0.5 kPa, p<0.0001). A less pronounced reduction in LSM values was observed in patients with comorbidities (baseline 10±9 vs last visit 8.5±5 kPa, p=0.07). Conclusions
Our real world data confirmed that long-term TDF monotherapy in patients with CHB is associated with a significant reduction in liver stiffness and thus a possible improvement in liver fibrosis. The reduction in LSM was noticeable mainly in patients with advanced fibrosis. Patients with comorbidities associated with metabolic syndrome do not seem to have significant decline in LSM despite their virological response Disclosure: H. Kranidioti: No Conflicts; A. A. Protopapas: No Conflicts; T. Voulgaris: No Conflicts; C. Tsolias: No Conflicts; P. ANTONAKAKI: No Conflicts; I. Segkou: No Conflicts; M. Deutsch: No Conflicts; C. Triantos: No Conflicts; J. Goulis: No Conflicts; G. Papatheodoridis: Abbvie: Advisory Committees or Review Panels, Speaking and Teaching, Grant/Research Support; Dicerna: Advisory Committees or Review Panels; Gilead: Advisory Committees or Review Panels, Speaking and Teaching, Grant/Research Support; Roche: Advisory Committees or Review Panels; Spring-Bank: Advisory Committees or Review Panels; S. Manolakopoulos: ABBVIE: Consulting; GILEAD: Grant/Research Support, Speaking and Teaching; GILEAD SCI: Consulting; IPSEN: Speaking and Teaching; MSD: Consulting; REGULUS: Grant/Research Support; [url=][/url]作者: StephenW 时间: 2020-5-5 20:03
背景与目标
长期使用TDF单药治疗的CHB患者的病毒学缓解与组织学改善有关。这项研究的目的是评估在接受TDF单药治疗的CHB患者队列中通过TE评估的纤维化变化。
方法
我们纳入了来自REST-B队列的CHB患者，这些患者接受TDF治疗超过36个月，并且至少进行了3次肝硬度测量（LSM）（基线，随访期间≥2）。病毒学缓解的定义是使用敏感的PCR分析方法检测不到血清HBV DNA。用瞬态TE（Fibroscan®）评估肝纤维化。晚期纤维化/肝硬化的临界值为9 kPa。
结果
总共包括107名患者。平均年龄为56±13岁，男性59例（55％），HBeAg阳性8例（7.5％）；中位随访期为79（范围：36-127）个月。分别在24和48个月时，病毒学缓解率分别为96％和98.6％，而ALT正常（<40 IU / L）的患者分别为87％和90％。在基线时，38％的患者至少患有以下合并症之一：高血压，糖尿病，血脂异常或BMI> 30。中位基线肝硬度为6.8（范围：3.5-40.5）kPa; 22％的患者患有晚期纤维化/肝硬化（平均LSM：16±13 kPa，而没有晚期纤维化的患者为6.3±1.3 kPa）。在合并症患者中观察到LSM显着升高（10.7±9 vs 7±3.2 kPa，p = 0.04）。在基线，24、36、48个月和最后一次就诊之间，平均LSM显着降低（分别为8.5±6 vs 7.9±4、7.5±4、7±4、7.5±5 kPa； p <0.001）。在最后一次就诊时，与基线相比，有20％的患者的LSM降低> 3 kPa。基线时患有晚期纤维化的患者的LSM平均降低率更高（4.9 vs 0.5 kPa，p <0.0001）。在合并症患者中观察到LSM值降低的幅度不太明显（基线10±9 vs上次访视8.5±5 kPa，p = 0.07）。
结论
我们的现实世界数据证实，CHB患者长期进行TDF单药治疗可显着降低肝脏僵硬程度，从而可能改善肝纤维化。 LSM的降低主要在晚期纤维化患者中明显。尽管有病毒学应答，但合并代谢综合征合并症患者的LSM似乎并未明显下降
披露：H. Kranidioti：无冲突； A. A. Protopapas：没有冲突； T. Voulgaris：没有冲突； C. Tsolias：没有冲突； P. ANTONAKAKI：没有冲突； I. Segkou：没有冲突；德意志先生：没有冲突； C. Triantos：没有冲突； J. Goulis：没有冲突； G. Papatheodoridis：Abbvie：咨询委员会或评审小组，口语和教学，拨款/研究支持； Dicerna：咨询委员会或审核小组；吉利德（Gilead）：咨询委员会或评审小组，口语和教学，拨款/研究支持；罗氏：咨询委员会或审查小组；春季银行：咨询委员会或审查小组； S. Manolakopoulos：ABBVIE：咨询； GILEAD：资助/研究支持，口语和教学； GILEAD SCI：咨询； IPSEN：口语和教学； MSD：咨询；条例：赠款/研究支持；
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