Mortazavi Shila, Hynicka Lauren M
Department of Pharmacy Practice and Science, University of Maryland School of Pharmacy, Baltimore, MD, USA.
J Pharm Technol. 2022 Aug;38(4):213-217. doi: 10.1177/87551225221092598. Epub 2022 Jun 4.
Direct-acting antiviral (DAA) agents have revolutionized the treatment of chronic hepatitis C virus (HCV) infection. Current data regarding the utility of on-treatment HCV viral load (VL) monitoring are conflicting and limited data are available in HIV-coinfected patients. The objective of the study was to determine whether on-treatment VLs are predictive of HCV cure in a real-world population. A single-center, retrospective cohort study was conducted using patients who received a prescription for DAA therapy for HCV treatment at a large, tertiary ambulatory care clinic. A total of 219 patients were included in the final analysis. The average age was 56 years. Most patients were male (64.4%), African American (73.1%), and insured by Medicaid (61.6%). Most patients were treatment-naive, noncirrhotic, and infected with HCV genotype 1a (73.1%). About 22.4% of patients were coinfected with HIV. The most common regimen was 12 weeks of ledipasvir/sofosbuvir (53.9%). On-treatment VLs were most commonly obtained at treatment week 4 (42.5%), of which 45.2% of patients were detectable. Sustained virologic response (SVR) was achieved in 96.8% of the total population and 95.9% of HIV-coinfected patients. Of the 7 patients who did not achieve SVR, 3 patients had undetectable on-treatment VLs in the first 8 weeks of therapy. Sustained virologic response rates were similar between HCV-monoinfected patients and HCV-HIV-coinfected patients. This research further supports that on-treatment VLs may not be a valuable indicator of treatment failure but may be helpful to engage patients in care and ensure treatment adherence and ultimately cure.
直接抗病毒（DAA）药物彻底改变了慢性丙型肝炎病毒（HCV）感染的治疗方式。目前关于治疗期间HCV病毒载量（VL）监测效用的数据相互矛盾，且在合并感染HIV的患者中可用数据有限。本研究的目的是确定在真实世界人群中，治疗期间的VL是否可预测HCV治愈情况。在一家大型三级门诊护理诊所，对接受DAA治疗HCV的患者进行了一项单中心回顾性队列研究。最终分析纳入了219例患者。平均年龄为56岁。大多数患者为男性（64.4%）、非裔美国人（73.1%），并由医疗补助计划承保（61.6%）。大多数患者既往未接受过治疗、无肝硬化，且感染HCV基因1a型（73.1%）。约22.4%的患者合并感染HIV。最常见的治疗方案是12周的来迪派韦/索磷布韦（53.9%）。治疗期间的VL最常在治疗第4周检测（42.5%），其中45.2%的患者可检测到病毒。总人群中96.8%以及合并感染HIV的患者中95.9%实现了持续病毒学应答（SVR）。在未实现SVR的7例患者中，3例在治疗的前8周治疗期间VL检测不到。HCV单一感染患者和HCV-HIV合并感染患者的持续病毒学应答率相似。这项研究进一步支持，治疗期间的VL可能不是治疗失败的有价值指标，但可能有助于促使患者接受治疗并确保治疗依从性，最终实现治愈。
