Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Inova Medicine, Inova Health System, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia.
Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Inova Medicine, Inova Health System, Falls Church, Virginia.
Clin Gastroenterol Hepatol. 2022 Feb;20(2):438-446. doi: 10.1016/j.cgh.2021.01.026. Epub 2021 Jan 22.
BACKGROUND & AIMS: Achieving sustained virologic response (SVR) among patients with hepatitis C virus (HCV) leads to patient reported outcome (PRO) improvement. We aimed to assess the long-term post-SVR PRO trends in HCV patients with cirrhosis.
Patients with HCV and cirrhosis treated in clinical trials with direct acting antiviral agents (DAAs) who achieved SVR-12 were prospectively enrolled in a long-term registry (clinicaltrials.gov #NCT02292706). PROs were collected every 24 weeks using the Short Form-36v2 (SF-36), CLDQ-HCV, and WPAI-HCV.
Pre-treatment baseline data were available for 854 cirrhotic patients who achieved SVR after DAAs. Of these, 730 had compensated (CC) and 124 had decompensated cirrhosis (DCC) before treatment- patients with DCC reported severe impairment in their PROs in comparison to CC patients (by mean -5% to -16% of a PRO range size; p < .05 for 16 out of 20 studied PROs]. After achieving SVR and registry enrollment, significant PRO improvements were noted from pre-treatment levels in 11/20 domains for those with DCC (+4% to +21%) and 19/20 PRO domains in patients with CC (+3% to +17%). Patients with baseline DCC had higher rates of hepatocellular carcinoma and mortality (P < .05). In patients with CC, the PRO gains persisted up to 168 weeks (3.5 years) of registry follow-up. In patients with DCC, the improvements lasted for at least 96 weeks but a declining trend after year 2.
Patients with HCV cirrhosis experience severe PRO impairment at baseline with sustainable improvement after SVR. Though those with DCC experience improvement, there is a decline after 2 years.
慢性丙型肝炎病毒（HCV）患者达到持续病毒学应答（SVR）可改善患者报告结局（PRO）。本研究旨在评估直接作用抗病毒药物（DAA）治疗后达到 SVR-12 的 HCV 合并肝硬化患者的 SVR 后长期 PRO 趋势。
前瞻性纳入在临床试验中接受 DAA 治疗并达到 SVR-12 的 HCV 合并肝硬化患者，随访时间长达 168 周（临床试验.gov #NCT02292706）。使用简明健康状况量表 36 项简表（SF-36）、克利夫兰临床肝脏病问卷（CLDQ-HCV）和工作影响健康问卷（WPAI-HCV）每 24 周评估一次 PRO。
854 例 DAA 治疗后达到 SVR 的肝硬化患者可提供治疗前基线数据。其中，730 例患者为代偿性肝硬化（CC），124 例为失代偿性肝硬化（DCC）。与 CC 患者相比，DCC 患者的 PRO 严重受损（各 PRO 范围大小的均值差异为-5%至-16%；20 个研究 PRO 中有 16 个差异有统计学意义，P <.05）。达到 SVR 并登记入组后，DCC 患者中有 11/20 PRO 域和 CC 患者中有 19/20 PRO 域的 PRO 从治疗前水平显著改善（分别为+4%至+21%和+3%至+17%）。基线时患有 DCC 的患者 HCC 发生率和死亡率更高（P <.05）。在 CC 患者中，PRO 获益可持续至登记后 168 周（3.5 年）。在 DCC 患者中，改善至少持续 96 周，但在第 2 年后呈下降趋势。
HCV 合并肝硬化患者的 PRO 在基线时严重受损，SVR 后可持续改善。尽管 DCC 患者的 PRO 改善，但在第 2 年后开始下降。
