Department of Pharmacy, University of California Irvine Medical Center, Orange, CA, USA.
Division of Gastroenterology and Hepatology, University of California Irvine, School of Medicine, 101 The City Drive, Building 56, Ste. 801, Orange, CA, 92868, USA.
Dig Dis Sci. 2021 Apr;66(4):1327-1334. doi: 10.1007/s10620-020-06286-3. Epub 2020 May 13.
Direct-acting antivirals (DAAs) are current standard of HCV treatment (Rx). However, data remain lacking on real-world safety, patterns of biochemical, virologic responses, and sustained virologic response (SVR12) rate in geriatric patients.
The present study assessed clinical presentation, safety, SVR12 rate, dynamic changes in HCV RNA, ALT, and AFP in geriatric patients (age ≥ 65 year old, G1) versus non-geriatric patients (G2) with chronic hepatitis C and received DAA treatment.
This was a single-center, retrospective study on 183 patients with DAA Rx and 12-week post-Rx follow-up.
There were no significant differences in patterns of biochemical and virologic responses between the two groups. Undetectable HCV RNA rates were 67.2% versus 75.7% (p = 0.22) and 77.3% versus 84.3% (p = 0.24) at Rx week 2 and Rx week 4, respectively. The SVR12 rate was comparable in 2 groups, 94.1% (G1) versus 95.7% (G2, p = 0.64). ALT normalization rates were 91.2% versus 91.3% (p = 0.98), 92.6% versus 93.9% (p = 0.74), and 97.1% versus 97.4% (p = 0.89) at Rx week 2, post-Rx week12, and post-Rx week 24, respectively. AFP normalization was lower in G1 with 89.7% versus 95.7% (p = 0.12), 77.9% versus 87.8% (p = 0.08), and 79.4% versus 92.2% (p = 0.01), at Rx week 2, and post-Rx week 12, and post-Rx week 24, respectively. Both groups showed similar side effects profile including fatigue 11.8% versus 12.2% (p = 0.93) and headache 11.8% versus 13.9% (p = 0.68).
Based on our real-world data, geriatric patients had excellent and comparable treatment outcomes with non-geriatric patients in safety and SVR12 rates to different DAA regimens.
直接作用抗病毒药物(DAAs)是目前 HCV 治疗(Rx)的标准。然而,关于老年患者的真实世界安全性、生化和病毒学应答模式以及持续病毒学应答(SVR12)率的数据仍然缺乏。
本研究评估了接受 DAA 治疗的老年患者(年龄≥65 岁,G1)与非老年患者(G2)慢性丙型肝炎的临床特征、安全性、SVR12 率、HCV RNA、ALT 和 AFP 的动态变化。
这是一项单中心、回顾性研究,纳入了 183 例接受 DAA Rx 和 12 周 Rx 随访的患者。
两组的生化和病毒学应答模式无显著差异。Rx 第 2 周和第 4 周 HCV RNA 不可检测率分别为 67.2%和 75.7%(p=0.22)和 77.3%和 84.3%(p=0.24)。两组 SVR12 率相似,分别为 94.1%(G1)和 95.7%(G2,p=0.64)。Rx 第 2 周、Rx 后第 12 周和 Rx 后第 24 周时,ALT 正常化率分别为 91.2%和 91.3%(p=0.98)、92.6%和 93.9%(p=0.74)和 97.1%和 97.4%(p=0.89)。G1 组 AFP 正常化率较低,分别为 89.7%和 95.7%(p=0.12)、77.9%和 87.8%(p=0.08)和 79.4%和 92.2%(p=0.01),在 Rx 第 2 周、Rx 后第 12 周和 Rx 后第 24 周。两组的不良反应谱相似,包括疲劳 11.8%和 12.2%(p=0.93)和头痛 11.8%和 13.9%(p=0.68)。
根据我们的真实世界数据,老年患者与非老年患者在不同 DAA 方案的安全性和 SVR12 率方面具有相似的治疗效果。