Department of Infectious Diseases, Odense University Hospital, Odense, Denmark.
OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark.
PLoS One. 2020 Dec 10;15(12):e0243725. doi: 10.1371/journal.pone.0243725. eCollection 2020.
To evaluate the ability of pretreatment liver stiffness measurements (pLSM) to predict hepatocellular carcinoma (HCC), incident decompensation and all-cause mortality in chronic hepatitis C (CHC) patients who achieved sustained virological response (SVR) after treatment with direct-acting antivirals (DAAs).
773 CHC patients with SVR after DAA treatment and no prior liver complications were identified retrospectively. Optimized cut-off of 17.5 kPa for incident HCC was selected by maximum Youden's index. Patients were grouped by pLSM: <10 kPa [reference], 10-17.4 kPa and ≥17.5 kPa. Primary outcomes were incident hepatocellular carcinoma and secondary outcomes were incident decompensated cirrhosis and all-cause mortality, analyzed using cox-regression.
Median follow-up was 36 months and 43.5% (336) had cirrhosis (LSM>12.5 kPa). The median pLSM was 11.6 kPa (IQR 6.7-17.8, range 2.5-75) and pLSM of <10 kPa, 10-17.4 kPa and 17.5-75 kPa was seen in 41.5%, 32.2% and 26.3%. During a median follow-up time of 36 months, 11 (1.4%) developed HCC, 14 (1.5%) developed decompensated cirrhosis, and 38 (4.9%) patients died. A pLSM of 17.5 kPa identified patients with a high risk of HCC with a negative predictive value of 98.9% and incidence rate of HCC in the 17.5-75 kPa group of 1.40/100 person years compared to 0.14/100 person years and 0.12/100 person years in the 10-17.4 kPa and <10 kPa groups, p<0.001.
Pretreatment LSM predicts risk of HCC, decompensation and all-cause mortality in patients with SVR after DAA treatment. Patients with a pLSM <17.5 kPa and no other risk factors for chronic liver disease appear not to benefit from HCC surveillance for the first 3 years after treatment. Longer follow-up is needed to clarify if they can be safely excluded from post treatment HCC screening hereafter.
评估治疗后获得持续病毒学应答（SVR）的慢性丙型肝炎（CHC）患者治疗前肝脏硬度测量值（pLSM）预测肝细胞癌（HCC）、新发失代偿和全因死亡率的能力。
回顾性分析了 773 例接受直接作用抗病毒药物（DAA）治疗后 SVR 且无既往肝脏并发症的 CHC 患者。通过最大 Youden 指数选择预测 HCC 的最佳截断值为 17.5kPa。根据 pLSM 将患者分为：<10kPa（参考）、10-17.4kPa 和≥17.5kPa。主要终点是 HCC 的新发，次要终点是新发失代偿性肝硬化和全因死亡率，采用 cox 回归分析。
中位随访时间为 36 个月，43.5%（336 例）有肝硬化（LSM>12.5kPa）。pLSM 中位数为 11.6kPa（IQR 6.7-17.8，范围 2.5-75），pLSM<10kPa、10-17.4kPa 和 17.5-75kPa 的比例分别为 41.5%、32.2%和 26.3%。在中位随访时间 36 个月期间，11 例（1.4%）发生 HCC，14 例（1.5%）发生失代偿性肝硬化，38 例（4.9%）死亡。pLSM 为 17.5kPa 可识别出 HCC 风险较高的患者，其阴性预测值为 98.9%，17.5-75kPa 组 HCC 的发生率为 1.40/100 人年，而 10-17.4kPa 组和<10kPa 组分别为 0.14/100 人年和 0.12/100 人年，p<0.001。
治疗前 LSM 可预测 DAA 治疗后 SVR 患者 HCC、失代偿和全因死亡率的风险。pLSM<17.5kPa 且无其他慢性肝病危险因素的患者，在治疗后 3 年内似乎不需要进行 HCC 监测。需要更长时间的随访，以明确此后是否可以安全地将其排除在治疗后 HCC 筛查之外。
