Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC 27599, USA.
J Viral Hepat. 2013 Aug;20(8):536-49. doi: 10.1111/jvh.12079. Epub 2013 Feb 25.
Adherence to treatment for hepatitis C virus (HCV) maximizes treatment efficacy. Missed doses and failing to persist on treatment are two patient-level processes that are rarely defined or analysed separately from other factors affecting treatment adherence. We evaluated the prevalence and patterns of missed doses and nonpersistence, and identified patient characteristics associated with these outcomes. Missed doses of ribavirin (RBV) and peginterferon (PEG), measured prospectively in Virahep-C using electronic monitoring technology, were analysed using generalized estimating equations. Cox proportional hazards models analysed time to nonpersistence from baseline to week 24 (N = 401) and from week 24 to 48 in Responders (N = 242). Average proportion of PEG- and RBV-missed doses increased over time from 5% to 15% and 7% to 27%, respectively. Patients who were younger, African-American, unemployed, or unmarried were at greater risk of missing PEG from week 0 to 24; higher baseline depression predicted missing PEG from weeks 24 to 48. Patients who were younger or African-American were more likely to miss daily RBV from weeks 0 to 24; and those without private insurance or employment were more likely to miss RBV from weeks 24 to 48. Fifty-two patients failed to persist on treatment for patient-driven deviations. Predictors of nonpersistence from weeks 0 to 24 included younger age, lower education, public or no insurance, or worse baseline headaches. In conclusion, electronic monitoring and the prospective Virahep-C design afforded a unique opportunity to evaluate missing doses and nonpersistence separately, and identify patients at risk of nonadherence. These processes will be important to investigate as the dosing schedules of antiviral regimens become increasingly complex.
患者对丙型肝炎病毒 (HCV) 治疗的依从性可最大程度提高治疗效果。漏服药物和不能坚持治疗是两个患者层面的过程，它们很少与影响治疗依从性的其他因素分开定义或分析。我们评估了漏服药物和不坚持治疗的发生率和模式，并确定了与这些结果相关的患者特征。使用电子监测技术在 Virahep-C 中前瞻性地测量了利巴韦林 (RBV) 和聚乙二醇干扰素 (PEG) 的漏服剂量，使用广义估计方程对其进行分析。Cox 比例风险模型分析了从基线到第 24 周（N = 401）和第 24 周到第 48 周（应答者 N = 242）的非持续性时间。从基线到第 24 周，PEG 和 RBV 的平均漏服剂量比例分别从 5%增加到 15%和从 7%增加到 27%；从第 0 周到第 24 周，年龄较小、非裔美国人、失业或未婚的患者漏服 PEG 的风险更高；基线时抑郁程度较高预示着从第 24 周到第 48 周漏服 PEG。从第 0 周到第 24 周，年龄较小或非裔美国人更有可能漏服每日 RBV；没有私人保险或就业的患者从第 24 周到第 48 周漏服 RBV 的可能性更大。52 名患者因患者驱动的偏差而无法坚持治疗。从第 0 周到第 24 周非持续性的预测因素包括年龄较小、教育程度较低、公共保险或没有保险，或基线时头痛更严重。总之，电子监测和前瞻性的 Virahep-C 设计为单独评估漏服药物和不坚持治疗提供了独特的机会，并确定了有不依从风险的患者。随着抗病毒治疗方案的剂量方案变得越来越复杂，这些过程将是重要的研究对象。
