AASLD2020[1028]长期PEG干扰素十年随访 慢性HDV肝炎的治疗

StephenW

1028
TEN-YEAR FOLLOW-UP OF LONG-TERM PEGINTERFERONALPHA
TREATMENT FOR CHRONIC DELTA HEPATITIS
Grace E Kim1, Julian Hercun1, Ben Da1, David E. Kleiner2,
Richard Chang3, Christopher Koh1 and Theo Heller1, (1)Liver
Diseases Branch, National Institute of Diabetes and Digestive
and Kidney Diseases, (2)Laboratory of Pathology, National
Cancer Institute, (3)Clinical Center, National Institutes of
Health
Background: Hepatitis delta virus (HDV) infection is the most
aggressive form of chronic hepatitis Response to 1 or 2 yearlong
peginterferon (IFN) treatment and sustained virological
response are sub-optimal We evaluated the long-term
outcomes of patients treated with an extended course of IFNalpha
at the National Institutes of Health Methods: Patients
were followed on a natural history protocol after completion of
trial NCT00023322, evaluating IFN treatment for up to 5 years
Baseline clinical and laboratory characteristics at treatment
initiation were recorded. Patients were classified according
to virological response defined as negative serum HDV RNA
(lower limit of detection 100 GE/mL) During extended followup,
long term survival and liver related events were recorded
Results: All 13 patients enrolled in the original study were
included in this analysis This group was 85% Caucasian and
85% male, with a mean age of 41 2 years at treatment initiation
The mean treatment duration was 75 months (range 2-397)
with a total follow-up duration of 104 months (range 2-211)
Patients had advanced compensated liver disease at baseline
with a median Ishak fibrosis score of 3, hepatic vein pressure
gradient of 11 mmHg, total bilirubin 0 9 mg/dL, and platelet
count 125 K/mcL Median AST was 80 U/L, ALT 84 U/L and
HDV RNA 7,300,000 GE/mL Baseline characteristics were
similar between both responders and non-responders At the
end of available follow-up, 7 (54%) patients had undetectable
HDV RNA levels. While two patients benefited from extension
of treatment beyond 5 years in order to achieve virological
response none required additional treatment afterwards
4 patients (31%) cleared hepatitis B surface antigen and
developed hepatitis B surface antibodies, however this was
not sustained in 1 case. In responders, a significant decrease
in ALT and AST (both p=0 016) was observed at end of followup
while no change was observed in non-responders No
changes in markers of cholestasis and platelet counts were
observed On long-term follow-up, 1/7 (14%) responders died
or had a liver related event (transplant, cholangiocarcinoma
or hepatocellular carcinoma) as opposed to 5/6 (83%) of
non-responders (p=0 03) Conclusion: With further follow-up,
extended course IFN-alpha therapy allows for sustained
clearance of HDV RNA in a majority of patients as well as
surface antigen seroconversion Treatment response is
significantly associated with favorable clinical outcomes.

StephenW

1028
长期PEG干扰素十年随访
慢性三角洲肝炎的治疗
Grace E Kim1，Julian Hercun1，Ben Da1，David E.Kleiner2，
Richard Chang3，Christopher Koh1和Theo Heller1，（1）肝脏
国立糖尿病与消化研究所疾病科
和肾脏疾病，（2）国家病理学实验室
癌症研究所（3）美国国立卫生研究院临床中心
健康
背景：三角洲肝炎病毒（HDV）感染最多
慢性肝炎的侵袭性形式对1或2年的反应
聚乙二醇干扰素（IFN）治疗和持续病毒学
响应不佳我们评估了长期
IFNα延长疗程的患者预后
美国国立卫生研究院方法：患者
完成后遵循自然历史记录
NCT00023322试验，评估IFN治疗长达5年
治疗时的基线临床和实验室特征
记录启动情况。根据患者分类
对病毒反应的定义为阴性血清HDV RNA
（检测下限100 GE / mL）在延长的随访期间，
记录长期生存和肝相关事件
结果：纳入原始研究的所有13名患者均
该分析包括85％白人和
85％的男性，开始治疗时的平均年龄为41 2岁
平均治疗时间为75个月（范围2-397）
总随访时间为104个月（范围2-211）
患者在基线时患有晚期代偿性肝病
Ishak纤维化中位数为3，肝静脉压
梯度为11 mmHg，总胆红素为0 9 mg / dL，血小板
计数125 K / mcL，AST中位数为80 U / L，ALT为84 U / L，
HDV RNA 7,300,000 GE / mL基线特征为
响应者和非响应者之间的相似之处
随访结束时，有7名（54％）患者无法检测到
HDV RNA水平。虽然两名患者受益于扩展
达到5年以上的治疗方案
反应后无需进一步治疗
4例患者（31％）清除了乙型肝炎表面抗原，
开发了乙型肝炎表面抗体，但是
1例未持续。在回应者中，大幅减少
随访结束时观察到ALT和AST（均为p = 0 016）
无反应者未见变化
胆汁淤积和血小板计数指标的变化为
在长期随访中观察到，有1/7（14％）的反应者死亡
或有肝脏相关事件（移植，胆管癌）
或肝细胞癌），而只有5/6（83％）
无回应者（p = 0 03）结论：在进一步的跟进中，
延长疗程的IFN-α治疗可以持续
大多数患者以及
表面抗原血清转化治疗反应为
与良好的临床结果显着相关。