Yang Anita, Swamy Neel, Giang Jane
J Am Pharm Assoc (2003). 2025 Jan-Feb;65(1):102265. doi: 10.1016/j.japh.2024.102265. Epub 2024 Oct 12.
Highly effective direct-acting antiviral (DAA) therapies have transformed the landscape of hepatitis C virus (HCV) treatment. However, there continues to be limited data regarding the efficacy and safety of required in-person clinic visits (standard monitoring) versus completely telehealth clinic visits (minimal monitoring) during HCV therapy, which could delay practice adoption.
This study aimed to assess the rates of undetectable HCV ribonucleic acid (RNA) in sustained viral load 12 weeks after therapy (SVR12) in standard versus minimal monitoring approaches during DAA.
A 12-month, single-center retrospective cohort study was conducted in treatment-naïve HCV-infected adults who received DAA therapy between May 1, 2020, and April 30, 2021. The standard monitoring group had ≥1 in-person clinic visit with HCV RNA laboratory monitoring during DAA treatment. The minimal monitoring group had entirely telehealth visits without HCV RNA laboratory monitoring during treatment. Both groups received telephonic touchpoints throughout DAA treatment from a clinical pharmacist practitioner and a nurse care coordinator. The primary outcome was SVR12.
From May 2020 to April 2021, 133 patients with HCV met inclusion criteria and were treated with DAA (standard, n = 56; minimal, n = 77), with no differences in baseline demographics. Overall, total encounters during DAA treatment remained statistically significant in the standard than minimal monitoring group (standard, 2.1 ± 0.8, vs. minimal, 1.7 ± 0.9; P < .01). Although minimal monitoring had higher loss to follow-up rates (standard, 7.1%, vs. minimal, 18.2%; P = 0.06), the modified intention-to-treat analysis showed no differences in sustained virologic response (SVR) between standard and minimal monitoring approaches (standard, 98.1%, n = 51, vs. minimal, 95.3%, n = 60; P = 0.41).
This single-center retrospective cohort study demonstrated that minimal monitoring during HCV treatment was as effective in achieving SVR cure rates as standard monitoring. Eliminating required in-person clinic visits during DAA therapy alongside a collaborative approach may play a major role in overcoming barriers to HCV care in select patients.
高效直接抗病毒（DAA）疗法改变了丙型肝炎病毒（HCV）的治疗格局。然而，关于HCV治疗期间所需的面对面诊所就诊（标准监测）与完全远程医疗诊所就诊（最小化监测）的疗效和安全性的数据仍然有限，这可能会延迟临床应用。
本研究旨在评估DAA治疗期间标准监测与最小化监测方法在治疗后12周持续病毒载量（SVR12）中HCV核糖核酸（RNA）检测不到的发生率。
对2020年5月1日至2021年4月30日期间接受DAA治疗的初治HCV感染成人进行了一项为期12个月的单中心回顾性队列研究。标准监测组在DAA治疗期间进行了≥1次面对面诊所就诊并进行HCV RNA实验室监测。最小化监测组在治疗期间完全通过远程医疗就诊，未进行HCV RNA实验室监测。两组在整个DAA治疗期间均接受了临床药剂师和护士护理协调员的电话随访。主要结局是SVR12。
2020年5月至2021年4月，133例HCV患者符合纳入标准并接受了DAA治疗（标准组，n = 56；最小化监测组，n = 77），基线人口统计学特征无差异。总体而言，DAA治疗期间的总就诊次数在标准监测组比最小化监测组仍有统计学意义（标准组，2.1±0.8，vs.最小化监测组，1.7±0.9；P <.01）。尽管最小化监测的失访率较高（标准组，7.1%，vs.最小化监测组，18.2%；P = 0.06），但改良意向性分析显示标准监测与最小化监测方法之间的持续病毒学应答（SVR）无差异（标准组，98.1%，n = 51，vs.最小化监测组，95.3%，n = 60；P = 0.41）。
这项单中心回顾性队列研究表明，HCV治疗期间的最小化监测在实现SVR治愈率方面与标准监测一样有效。在DAA治疗期间取消所需的面对面诊所就诊并采用协作方法可能在克服特定患者HCV治疗障碍方面发挥重要作用。
