患有乙肝阴性慢性乙型肝炎（CHB）的非乙型肝炎患者的长期

StephenW

Sa1521 — 2020                             AASLD                                                 Poster of Distinction                         LONG-TERM OUTCOME IN NON-CIRRHOTIC PATIENTS WITH HBEAG-NEGATIVE CHRONIC HEPATITIS B (CHB) WHO STOPPED ENTECAVIR (ETV) OR TENOFOVIR (TDF) THERAPY. FINAL RESULTS OF A MULTICENTER PROSPECTIVE STUDY

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    Liver Diseases and Transplantation
    I04 Therapeutics - Approved Agents
Presented on Saturday, May 2, 2020 12:30 PM

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Author(s):     Spilios Manolakopoulos1,2, Hariklia Kranidioti1, Anastasia Kourikou1, Christos Triantos3, Emanuel K. Manesis4, Nikoletta Mathou5, Alexandra Alexopoulou1, Melanie Deutsch1, Emilia Hadziyannis1, George Papatheodoridis2

    Background
Several studies mainly from Asia have suggested that Nucleos(t)ide Analogue (NA) discontinuation is safe in HBeAg-negative non-cirrhotic CHB patients; however, the long-term outcome remains unknown. The aim of this analysis was to address the rate of functional cure in non-cirrhotic HBeAg-negative CHB patients who stopped ETV or TDF therapy and had at least 3 years follow up.
Methods
Our prospective study included non-cirrhotic HBeAg-negative CHB patients who discontinued ETV or TDF after median on-therapy virological remission of 6 years. All patients had regularly blood tests, serum HBV-DNA and HBsAg quantification. All patients with retreatment criteria designated by the study protocol restarted ETV or TDF.
Results
The cohort included 57 patients with >36 months follow-up; 29 of them remained without retreatment after a median of 65 (range: 36-87) months following treatment discontinuation. Cumulative rates of retreatment at 3, 6, 12, 24, 36, and 48 months were 16%, 20%, 32%, 35%, 46% and 50% respectively. All patients who restarted NA treatment had virological and biochemical response. The proportion of patients with HBV-DNA <2000 IU/mL and ALT <40 IU/L were 73%, 60%, 52%, 52%, 47% and 37% at 3, 6, 12, 24, 36, and 48 months, respectively. None of the patients presented jaundice, liver failure, hepatocellular carcinoma or death. Eight of the 29 (27.6%) patients who remained without retreatment lost HBsAg during the follow-up. Cumulative rate of HBsAg loss was 2%, 4%, 7%, 7% and 20% at 3, 6, 12, 24 and 36 months. None of the patients with HBsAg loss had a biochemical flare, five had HBV DNA >2000 and two HBV DNA >20,000 IU/mL during follow-up. HBsAg levels <100 IU/mL at the end of NA treatment could predict HBsAg loss (p=0.001).
Conclusion
This prospective study postulated that ETV or TDF can be safely stopped in HBeAg-negative non-cirrhotic CHB patients. After a median follow up of 65 months, half of the patients remain untreated, while a substantial proportion of them may achieve functional cure     

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Disclosure:    S. Manolakopoulos: ABBVIE: Consulting; GILEAD: Grant/Research Support, Speaking and Teaching; GILEAD SCI: Consulting; IPSEN: Speaking and Teaching; MSD: Consulting; REGULUS: Grant/Research Support; H. Kranidioti: No Conflicts; A. Kourikou: No Conflicts; C. Triantos: No Conflicts; E. K. Manesis: No Conflicts; N. Mathou: No Conflicts; A. Alexopoulou: No Conflicts; M. Deutsch: No Conflicts; E. Hadziyannis: 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;

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StephenW

Sa1521年-2020年AASLD卓越奖海报
患有乙肝阴性慢性乙型肝炎（CHB）的非乙型肝炎患者的长期结果，该患者应停止Entecavir（ETV）或Tenofovir（TDF）治疗。多中心预期研究的最终结果
肝病和移植
I04治疗-批准的代理商
提出于2020年5月2日星期六12:30 PM
作者：Spilios Manolakopoulos1,2，Hariklia Kranidioti1，Anastasia Kourikou1，Christos Triantos3，Emanuel K.Manesis4，Nikoletta Mathou5，Alexandra Alexopoulou1，Melanie Deutsch1，Emilia Hadziyannis1，George Papatheodoridis2

背景
几项主要来自亚洲的研究表明，在HBeAg阴性非肝硬化CHB患者中，Nucleos（t）ide Analogue（NA）的停用是安全的。然而，长期结果仍然未知。这项分析的目的是解决停止ETV或TDF治疗并至少随访3年的非肝硬化HBeAg阴性CHB患者的功能治愈率。
方法
我们的前瞻性研究包括非肝硬化的HBeAg阴性CHB患者，他们在中位治疗病毒学中位数缓解6年后中断了ETV或TDF。所有患者均定期进行血液检查，血清HBV-DNA和HBsAg定量。所有符合研究方案指定的治疗标准的患者均应重新开始ETV或TDF。
结果
该队列包括57名患者，随访时间> 36个月。在中断治疗后的中位数为65（范围：36-87）个月之后，其中29例仍未进行再治疗。 3、6、12、24、36和48个月的再治疗累积率分别为16％，20％，32％，35％，46％和50％。所有重新开始NA治疗的患者都有病毒学和生化反应。分别在3、6、12、24、36和分别为48个月。没有患者出现黄疸，肝功能衰竭，肝细胞癌或死亡。在随访期间，其余29例患者中有8例（27.6％）仍未接受治疗而丢失了HBsAg。在3、6、12、24和36个月时，HBsAg的累积流失率分别为2％，4％，7％，7％和20％。在随访期间，没有HBsAg丢失的患者没有生化发作，有5例HBV DNA> 2000和2例HBV DNA> 20,000 IU / mL。 NA治疗结束时HBsAg水平<100 IU / mL可以预测HBsAg丢失（p = 0.001）。
结论
这项前瞻性研究假设，HBeAg阴性非肝硬化CHB患者可以安全地停止ETV或TDF。在中位随访65个月后，一半的患者仍未接受治疗，而其中很大一部分患者可实现功能性治愈
披露：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； H. Kranidioti：没有冲突； A. Kourikou：没有冲突； C. Triantos：没有冲突； E. K. Manesis：没有冲突； N. Mathou：没有冲突； A. Alexopoulou：没有冲突；德意志先生：没有冲突； E. Hadziyannis：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；