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长期恩替卡韦(ETV) / 替诺福韦(TDF)治疗在任何严重程度的CHB中都是最常见的治疗选择,但功效数据主要基于治疗中的病毒学缓解率。 在10个中心大规模研究中,来自雅典大学医学院的研究者们评估了患有或未患有长期ETV / TDF治疗的肝硬化的白种人乙型肝炎(CHB)患者的生存率,该结论发表在此次2016AASLD上。
研究中包括1954名成年有或无补偿性肝硬化的白种人慢性乙型肝炎患者和在基线时没有接受ETV / TDF≥12个月(中位数:6年)的肝癌患者(平均年龄:5314年,男性:71%,口服抗病毒:58%,肝硬化:27%)。 从Kaplan-Meier曲线评估肝移植(LT)的存活率。
研究结果显示,在患者总人群中,1-,3-,5-和8-年总生存率分别为99.7%,97.7%,95.8%和94.0%,在非肝硬化(100%,98.5%,97.3%和96.2%)中显着高于肝硬化(98.9%,95.5%,92.4%和88.9%,P <0.001)。当仅考虑肝相关的死亡率或LT时,1-,3-,5-和8-年存活率分别为99.8%,99.1%,98.0%和97.1%, 在非肝硬化患者中(100%,99.8%,99.1%和98.7%)明显比肝硬化患者(99.2%,97.2%,95.5%和93.6%,P < 001)有显著提高。排除发生肝癌患者后,非 - 肝硬化患者的1-,3-,5-和8-年总生存率分别为99.8%,98.3%,97.2%和96.1% (99.1%,97.0%,95.1%和92.8%,P <0.001)显著高于肝硬化(100%,98.7%,98.1%和97.4%)。 在118例 肝细胞癌患者中,1-,3-和5-年总生存率分别为87.6%,59.6%和46.8%,在非肝硬化和肝硬化之间没有任何差异(P = 0.224 )。在多变量Cox回归分析中,更好的总生存率与肝细胞癌独立相关[HR:5.588(95%CI:3.439-9.080),P <0.001]和年轻年龄 1.060(1.038-1.083),P <0.001],但与肝硬化(P = 0.087)或性别(P = 0.743)无关。的肝相关生存仅与不存在肝细胞癌相关 [HR:32 .132(14 .195-72.731),P <0.001],而与年龄(P = 0.085),及硬化(P = .692)无关
研究结果表明,用ETV / TDF治疗的白种人慢性乙型肝炎的存活率优良,> 95%的病例在5年存活并且大部分死亡来自肝脏无关的原因。肝细胞癌是影响总体死亡率的主要因素,并且是影响这些患者肝脏相关死亡率的唯一因素。
编号:68
Hepatocellular carcinoma (HCC) is the only factor affecting the excellent survival of Caucasian chronic hepatitis B (CHB) patients with or without cirrhosis under longterm entecavir (ETV) or tenofovir (TDF) therapy
When only liver related deaths or LT were taken into account, 1-, 3-, 5- and 8-year survival rates were 99 .8%, 99 .1%, 98 .0% and 97 .1% being also significantly higher in non-cirrhotics (100%, 99 .8%, 99 .1% and 98 .7%) than cirrhotics (99 .2%, 97 .2%, 95 .5% and 93 .6%, P<0 .001) .
Background/Aim: Long-term ETV/TDF therapy represents the most common treatment option in CHB of any severity, but efficacy data have been mainly based on on-therapy virological remission rates . In this 10-center, large ongoing cohort study,we evaluated the survival in Caucasian CHB patients with or without cirrhosis who have been treated with long-term ETV/TDF therapy .
Methods: We included 1954 adult Caucasians with CHB with or without compensated cirrhosis and no HCC at baseline (mean age: 53±14 years, males: 71%, naive to oral antivirals: 58%, cirrhosis: 27%) who received ETV/TDF for ≥12 months (median: 6 years) . Liver transplantation (LT) free survival rates were estimated from Kaplan-Meier curves .
Results: In the total patient population, 1-, 3-, 5-, and 8-year overall survival rates were 99 .7%, 97 .7%, 95 .8% and 94 .0% being significantly higher in non-cirrhotics (100%, 98 .5%, 97 .3% and 96 .2%) than cirrhotics (98 .9%, 95 .5%, 92 .4% and 88 .9%, P<0 .001) .
After excluding patients who developed HCC, 1-, 3-, 5- and 8-year overall survival rates were 99 .8%, 98 .3%, 97 .2% and 96 .1% remaining significantly higher in non-cirrhotics (100%, 98 .7%, 98 .1% and 97 .4%) than cirrhotics (99 .1%, 97 .0%, 95 .1% and 92 .8%, P<0 .001) . In the 118 patients with HCC, the 1-, 3- and 5-year overall survival rates were 87 .6%, 59 .6% and 46 .8% without any difference between non-cirrhotics and cirrhotics (P=0 .224) .
In multivariable Cox regression analysis, better overall survival was independently associated with absence of HCC [HR: 5 .588 (95% CI: 3 .439-9 .080), P<0 .001] and younger age [HR per year: 1 .060 (1 .038-1 .083), P<0 .001] but not with cirrhosis (P=0 .087) or gender (P=0 .743), while better liver related survival was associated only with absence of HCC [HR: 32 .132 (14 .195-72 .731), P<0 .001] and not with age (P=0 .085), cirrhosis (P=0 .201) or gender (P=0 .692) .
Conclusions: The survival of Caucasian CHB patients treated with ETV/TDF is excellent with >95% of cases surviving at 5 years and a significant proportion of deaths coming from liver unrelated causes . HCC development is the major factor affecting the overall mortality and the only factor affecting liver related mortality in such patients .
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