■目前尚不清楚直接抗病毒药物(DAA)治疗是否能改善丙型肝炎病毒(HCV)感染的疾病负担。本研究旨在使用个体参与者数据调查DAA治疗对降低HCV感染患者疾病负担的影响。
■这项全国性的多中心回顾性队列研究招募了来自韩国29个大专院校的HCV感染患者。数据收集是从每个机构的医疗记录中进行的。该研究包括未经治疗的患者和DAA治疗的患者,并排除了那些有干扰素治疗史的患者。疾病负担是主要结果,以残疾调整寿命年(DALYs)表示。使用APRI评估DAA治疗后纤维化的改善,FIB-4指数,和通过瞬时弹性成像评估的肝脏硬度(LS)。临床结果为肝细胞癌(HCC),代偿失调,和死亡率。
■2007年1月1日至2022年2月17日,来自11,725名HCV感染患者的数据,8464人(72%)接受了DAAs治疗,进行了分析。DAA治疗显着改善APRI-(中位数0.64[四分位数间距(IQR),0.35-1.31]-0.33[0.23-0.52],p<0.0001),FIB-4-(中位数2.42[IQR,1.48-4.40]-1.93[1.31-2.97],p<0.0001),和肝脏LS基纤维化(中位数7.4[IQR,5.3-12.3]-6.2[4.6-10.2]kPa,p<0.0001)。在27.5个月的中位随访期内(IQR,10.6-52.4),469例患者死亡(4.0%),586(5.0%)发展为HCC,580人(4.9%)出现代偿失调。DAA组基于APRI的DALY估计值显着低于未治疗组(中位数4.55vs.5.14年,p<0.0001),基于FIB-4的DALY估计也是如此(中位数5.43[IQR,3.00-6.44]vs.5.79[3.85-8.07]年,p<0.0001)。在40-60岁的患者中,未治疗组和DAA组之间的差异最大。在多变量分析中,DAA组肝癌的风险显著降低,代偿失调,和死亡率与未治疗组相比(风险比:0.41[95%置信区间(CI),0.34-0.48],0.31[95%CI,0.30-0.38],和0.22[95%CI,0.17-0.27],分别为;p<0.0001)。
■我们的研究结果表明,DAA治疗与HCV感染患者肝脏相关结局的改善和肝纤维化疾病负担的减少有关。然而,需要使用肝活检进行进一步的研究,以阐明DAA治疗对降低基于纤维化的疾病负担的确切影响,而不是非侵入性试验.
■韩国疾病控制和预防机构。
UNASSIGNED: It is unclear whether direct-acting antivirals (DAAs) treatment improves the disease burden in hepatitis C virus (HCV) infection. This study aimed to investigate the effect of DAA treatment on the reduction of disease burden in patients with HCV infection using individual participant data.
UNASSIGNED: This nationwide multicentre retrospective cohort study recruited patients with HCV infection from 29 tertiary institutions in South Korea. The data collection was done from medical records in each institution. The study included the untreated patients and the DAAs-treated patients and excluded those with a history of interferon-based treatments. Disease burden was the primary outcome, as represented by disability-adjusted life years (DALYs). Improvement in fibrosis after DAA treatment was assessed using APRI, FIB-4 index, and liver stiffness (LS) as assessed by transient elastography. Clinical outcomes were hepatocellular carcinoma (HCC), decompensation, and mortality.
UNASSIGNED: Between January 1, 2007, and February 17, 2022, data from 11,725 patients with HCV infection, 8464 (72%) of whom were treated with DAAs, were analysed. DAA treatment significantly improved APRI- (median 0.64 [interquartile range (IQR), 0.35-1.31]-0.33 [0.23-0.52], p < 0.0001), FIB-4- (median 2.42 [IQR, 1.48-4.40]-1.93 [1.31-2.97], p < 0.0001), and liver LS-based fibrosis (median 7.4 [IQR, 5.3-12.3]-6.2 [4.6-10.2] kPa, p < 0.0001). During the median follow-up period of 27.5 months (IQR, 10.6-52.4), 469 patients died (4.0%), 586 (5.0%) developed HCC, and 580 (4.9%) developed decompensation. The APRI-based DALY estimate was significantly lower in the DAA group than in the untreated group (median 4.55 vs. 5.14 years, p < 0.0001), as was the FIB-4-based DALY estimate (median 5.43 [IQR, 3.00-6.44] vs. 5.79 [3.85-8.07] years, p < 0.0001). The differences between the untreated and DAA groups were greatest in patients aged 40-60 years. In multivariable analyses, the DAA group had a significantly reduced risk of HCC, decompensation, and mortality compared with the untreated group (hazard ratios: 0.41 [95% confidence interval (CI), 0.34-0.48], 0.31 [95% CI, 0.30-0.38], and 0.22 [95% CI, 0.17-0.27], respectively; p < 0.0001).
UNASSIGNED: Our findings suggest that DAA treatment is associated with the improvement of liver-related outcomes and a reduction of liver fibrosis-based disease burden in patients with HCV infection. However, further studies using liver biopsy are needed to clarify the effect of DAA treatment on the reduction in the exact fibrosis-based disease burden beyond noninvasive tests.
UNASSIGNED: The Korea Disease Control and Prevention Agency.