Smith Scott R, Wahed Abdus S, Kelley Stephanie S, Conjeevaram Hari S, Robuck Patricia R, Fried Michael W
The Center for Outcomes & Evidence, Agency for Healthcare Research & Quality, Rockville, MD 20850, USA.
Ann Pharmacother. 2007 Jul;41(7):1116-23. doi: 10.1345/aph.1K024. Epub 2007 May 22.
To assess the validity of self-reported medication adherence provided by individuals in treatment for hepatitis C virus (HCV) infection with a regimen of peginterferon and ribavirin.
Adherence was evaluated prospectively among 196 African American and 205 white subjects enrolled in Virahep-C (Viral Resistance to Antiviral Therapy of Chronic Hepatitis C), a treatment study for genotype 1 HCV infection. Adherence to the prescribed dose was measured by 2 methods: self-report questions administered during multiple clinic visits, using a touch screen computer; and recordings of bottle openings, using an electronic monitor placed inside the cap of prescription containers. Self-reported responses were compared with the electronic monitor data. Nonparametric tests were used to test the association between adherence measures at 4, 12, 24, 36, and 48 weeks of treatment.
The estimated proportion of participants who were adherent prior to a given visit ranged from 85% to 97% (ribavirin) and 97% to 100% (peginterferon) by self report and from 69% to 90% (ribavirin) and 84% to 100% (peginterferon) by electronic monitors. For ribavirin, the percentage of cases in which the 2 measurement methods agreed varied from 68% to 90%; peginterferon agreement was from 84% to 100%. Overall, adherence was higher for peginterferon than for ribavirin but decreased over time for both medications. Self-reported adherence was usually higher than that assessed by electronic measures, and the level of discrepancy increased during the course of treatment.
Adherence to peginterferon and ribavirin decreased gradually during therapy but remained relatively high. Simple self-reported measures can be used to screen for nonadherence to HCV drug therapy, but should be considered as overestimation of the actual amounts taken.
评估接受聚乙二醇干扰素和利巴韦林方案治疗丙型肝炎病毒（HCV）感染的个体自我报告的药物依从性的有效性。
在196名非裔美国人和205名白人受试者中对依从性进行前瞻性评估，这些受试者参与了Virahep-C（慢性丙型肝炎抗病毒治疗的病毒耐药性）研究，这是一项针对1型HCV感染的治疗研究。通过两种方法测量对规定剂量的依从性：在多次门诊就诊期间使用触摸屏计算机进行自我报告问题调查；使用放置在处方容器瓶盖内的电子监测器记录药瓶开封情况。将自我报告的回答与电子监测器数据进行比较。使用非参数检验来检验治疗4、12、24、36和48周时依从性测量之间的关联。
根据自我报告，在给定就诊前依从治疗的参与者估计比例在85%至97%（利巴韦林）和97%至100%（聚乙二醇干扰素）之间；根据电子监测器，该比例在69%至90%（利巴韦林）和84%至100%（聚乙二醇干扰素）之间。对于利巴韦林，两种测量方法一致的病例百分比在68%至90%之间；聚乙二醇干扰素的一致性在84%至100%之间。总体而言，聚乙二醇干扰素的依从性高于利巴韦林，但两种药物的依从性均随时间下降。自我报告的依从性通常高于电子测量评估的依从性，且差异水平在治疗过程中增加。
在治疗期间，对聚乙二醇干扰素和利巴韦林的依从性逐渐下降，但仍保持相对较高水平。简单的自我报告措施可用于筛查丙型肝炎药物治疗的不依从情况，但应视为对实际服用量的高估。
