■由于实践模式和丙型肝炎病毒(HCV)基因型(GT)在地理上有所不同,来自东方和西方的涵盖所有GTs的全球现实世界研究有助于为2030年HCV消除目标制定实践政策.本研究旨在评估DAA治疗在常规临床实践中的有效性和耐受性在多国队列中感染所有HCVGTs的患者。专注于GT3和GT6。
■我们分析了15,849名慢性丙型肝炎患者的持续病毒学应答(SVR12),这些患者来自39个来自亚太地区亚洲肝脏联盟HCV临床站点的真实世界证据,北美,和欧洲之间的2014/01-2021/07/01。
■平均年龄为62±13岁,男性占49.6%。人口统计细分为91.1%的亚洲人(52.9%的日本人,25.7%中国人/台湾人,5.4%韩国人,3.3%马来西亚,和2.9%的越南人),6.4%白色,1.3%西班牙裔/拉丁裔,和1%的黑人/非洲裔美国人。此外,34.8%患有肝硬化,8.6%患有肝细胞癌(HCC),24.9%有治疗经验(20.7%使用干扰素,4.3%,直接作用抗病毒药物)。最大的群体是GT1(10,246[64.6%]),其次是GT2(3,686[23.2%]),GT3(1,151[7.2%]),GT6(457[2.8%]),GT4(47[0.3%]),GT5(1[0.006%]),和无类型的GT(261[1.6%])。整体SVR12为96.9%,GT1/2/3/6的比率超过95%,而GT4的比率为91.5%。GT3的SVR12总体为95.1%,GT3a的98.2%,GT3b为94.0%。对于GT6,SVR12总体为98.3%,对于肝硬化和治疗经历(TE)的患者较低(93.8%),但对于初治患者,无论肝硬化状态如何,均≥97.5%。在多变量分析中,高龄,先前治疗失败,肝硬化,活动性肝癌,和GT3/4是较低SVR12的独立预测因子,而亚洲人是达到SVR12的重要预测因子。
■在这个由各种GTs患者组成的多元化跨国现实世界队列中,总治愈率为96.9%,尽管有大量的肝硬化患者,HCC,TE,GT3/6肝硬化和TE的GT3/6的SVR12较低,但仍然很好(>91%)。
UNASSIGNED: As practice patterns and hepatitis C virus (HCV) genotypes (GT) vary geographically, a global real-world study from both East and West covering all GTs can help inform practice policy toward the 2030 HCV elimination goal. This study aimed to assess the effectiveness and tolerability of
DAA treatment in routine clinical practice in a multinational cohort for patients infected with all HCV GTs, focusing on GT3 and GT6.
UNASSIGNED: We analyzed the sustained virological response (SVR12) of 15,849 chronic hepatitis C patients from 39 Real-World Evidence from the Asia Liver Consortium for HCV clinical sites in Asia Pacific, North America, and Europe between 07/01/2014-07/01/2021.
UNASSIGNED: The mean age was 62±13 years, with 49.6% male. The demographic breakdown was 91.1% Asian (52.9% Japanese, 25.7% Chinese/Taiwanese, 5.4% Korean, 3.3% Malaysian, and 2.9% Vietnamese), 6.4% White, 1.3% Hispanic/Latino, and 1% Black/African-American. Additionally, 34.8% had cirrhosis, 8.6% had hepatocellular carcinoma (HCC), and 24.9% were treatment-experienced (20.7% with interferon, 4.3% with direct-acting antivirals). The largest group was GT1 (10,246 [64.6%]), followed by GT2 (3,686 [23.2%]), GT3 (1,151 [7.2%]), GT6 (457 [2.8%]), GT4 (47 [0.3%]), GT5 (1 [0.006%]), and untyped GTs (261 [1.6%]). The overall SVR12 was 96.9%, with rates over 95% for GT1/2/3/6 but 91.5% for GT4. SVR12 for GT3 was 95.1% overall, 98.2% for GT3a, and 94.0% for GT3b. SVR12 was 98.3% overall for GT6, lower for patients with cirrhosis and treatment-experienced (TE) (93.8%) but ≥97.5% for treatment-naive patients regardless of cirrhosis status. On multivariable analysis, advanced age, prior treatment failure, cirrhosis, active HCC, and GT3/4 were independent predictors of lower SVR12, while being Asian was a significant predictor of achieving SVR12.
UNASSIGNED: In this diverse multinational real-world cohort of patients with various GTs, the overall cure rate was 96.9%, despite large numbers of patients with cirrhosis, HCC, TE, and GT3/6. SVR12 for GT3/6 with cirrhosis and TE was lower but still excellent (>91%).