Department of Internal Medicine, The Catholic University of Korea, College of Medicine, Seoul, Korea.
Liver Cirrhosis Clinical Research Center, Seoul, Korea.
Hepatology. 2015 Jun;61(6):1809-20. doi: 10.1002/hep.27723. Epub 2015 Mar 18.
The effect of viral suppression on long-term disease outcome after decompensation in patients with hepatitis B virus (HBV)-related cirrhosis has not been established. The aim of this study was to determine the long-term effect of antiviral therapy (AVT) in patients with HBV-related decompensated cirrhosis. This was a multicenter, prospective, inception cohort study of 707 patients who presented with first-onset decompensated complications, including 284 untreated and 423 antiviral-treated patients (58 previously treated, 253 with early treatment, and 112 with delayed treatment). The primary endpoint was 5-year liver transplantation (LT)-free survival. Secondary endpoints included virological response (VR) and serological response and improvement in liver function. Despite baseline high HBV activity and worse liver function, antiviral-treated patients had significantly better transplant-free survival than untreated patients (5-year survival rates of 59.7% vs. 46.0%, respectively), with more apparent benefits from antivirals in Child-Turcotte-Pugh class B/C and high-viremia groups. The rate of VR and hepatitis B e antigen seroconversion at 5 years in antiviral-treated patients was 14.2% and 49.1%, respectively. A significant improvement in liver function was observed in treated versus untreated patients, with 33.9% of treated patients delisted for LT. Patients with early treatment had better clinical outcomes than those with delayed treatment. Survival was dependent on antiviral response, being significantly better in responders than in nonresponders or untreated cases. The initial benefit of AVT was negated over time in nonresponders. Antiviral treatment and maintained VR remained independently predictive of survival. The study results were corroborated by propensity score-matching analysis.
AVT significantly modifies the natural history of decompensated cirrhosis, improving liver function and increasing survival. The results underscore the importance of promptly administering potent antiviral drugs to patients under consideration for LT.
本研究旨在确定抗病毒治疗（AVT）对乙型肝炎病毒（HBV）相关失代偿性肝硬化患者的长期影响。
这是一项多中心、前瞻性、起始队列研究，共纳入 707 例首次出现失代偿并发症的患者，包括 284 例未治疗和 423 例抗病毒治疗患者（58 例既往治疗，253 例早期治疗，112 例延迟治疗）。主要终点是 5 年无肝移植（LT）生存。次要终点包括病毒学应答（VR）和血清学应答以及肝功能改善。
尽管基线时 HBV 活性高且肝功能更差，但抗病毒治疗组的无移植生存明显优于未治疗组（5 年生存率分别为 59.7%和 46.0%），在 Child-Turcotte-Pugh 分级 B/C 和高病毒血症组中抗病毒治疗的获益更为明显。抗病毒治疗患者在 5 年时的 VR 率和乙型肝炎 e 抗原血清学转换率分别为 14.2%和 49.1%。与未治疗组相比，治疗组的肝功能显著改善，33.9%的治疗组患者被取消 LT 适应证。与延迟治疗组相比，早期治疗患者的临床结局更好。生存与抗病毒应答相关，应答者的生存明显好于无应答者或未治疗者。在无应答者中，AVT 的初始获益随时间推移而被否定。抗病毒治疗和持续的 VR 仍然是独立预测生存的因素。倾向评分匹配分析结果证实了研究结果。
AVT 显著改变了失代偿性肝硬化的自然史，改善了肝功能并提高了生存率。研究结果强调了及时向考虑 LT 的患者给予强效抗病毒药物的重要性。
