Relationship between adherence to hepatitis C virus therapy and virologic outcomes: a cohort study.

Relationship between adherence to hepatitis C virus therapy and virologic outcomes: a cohort study.
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DOI:
10.7326/0003-4819-155-6-201109200-00003
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发表时间:
2011-09-20
影响因子:
39.2
通讯作者:
Gross R
Gross R
中科院分区:
医学1区
文献类型:
--
作者:
Lo Re V 3rd;Teal V;Localio AR;Amorosa VK;Kaplan DE;Gross R

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聚乙二醇干扰素和利巴韦林丙型肝炎病毒 (HCV) 治疗的依从性尚未得到完全检查。评估 HCV 治疗依从性与早期和持续病毒学应答之间的关系,评估依从性随时间的变化,并检查不依从性的危险因素。回顾性队列研究。国家退伍军人事务部丙型肝炎临床病例登记 5,706 名 HCV 感染患者(基因型 1、2、3 或 4)在 2003 年至 2006 年间至少服用过一张聚乙二醇化干扰素和利巴韦林处方,并且在治疗开始之前和之后进行了 HCV RNA 结果。使用药房补充数据以 12 周为间隔计算依从性。终点包括早期病毒学应答(12周时HCV RNA减少≥2 log10)和持续病毒学应答(治疗结束后24周HCV RNA检测不到)。在最初 12 周的治疗中,早期病毒学应答随着利巴韦林依从性的提高而增加(基因型 1, 4:25/68 [37%],最低类别 [≤40% 依从性] 与 1,367/2,187 [63%],最高类别 [91–100% 依从性],p<0.001;基因型 2, 3:12/18 [67%] 的依从性≤40%,而 651/713 [91%] 的依从性为 91-100%,p<0.001)。在基因型 1 和 4 患者中,在第二个、第三个和第四个 12 周间隔内,持续反应随着利巴韦林依从性的提高而增加。干扰素依从性的结果相似。每 12 周间隔,干扰素和利巴韦林的平均依从性分别下降 3.4% 和 6.6%(趋势检验,每种药物的 p<0.001)。在治疗期间服用生长因子或甲状腺药物的患者平均抗病毒依从性较高。没有标准化结果测量时间的观察性研究。随着干扰素和利巴韦林依从性的提高,早期和持续的病毒学反应也会增加。随着时间的推移,两种抗病毒药物的依从性都会下降,但利巴韦林的依从性下降更严重。
Adherence to hepatitis C virus (HCV) therapy with pegylated interferon and ribavirin has been incompletely examined. To evaluate the relationship between adherence to HCV therapy and early and sustained virologic response, assess changes in adherence over time, and examine risk factors for non-adherence. Retrospective cohort study. National Veterans Affairs Hepatitis C Clinical Case Registry 5,706 HCV-infected patients (genotypes 1, 2, 3, or 4) with at least one prescription for pegylated interferon and ribavirin between 2003 and 2006 and HCV RNA results prior to and after treatment initiation. Adherence was calculated over 12-week intervals using pharmacy refill data. Endpoints included early virologic response (decrease of ≥2 log10 HCV RNA at 12 weeks) and sustained virologic response (undetectable HCV RNA 24 weeks after end of treatment). Early virologic response increased with higher levels of ribavirin adherence over the initial 12 weeks of therapy (genotype 1, 4: 25/68 [37%] with the lowest category [≤40% adherence] versus 1,367/2,187 [63%] with the highest category [91–100% adherence], p<0.001; genotype 2, 3: 12/18 [67%] with ≤40% adherence versus 651/713 [91%] with 91–100% adherence, p<0.001). Among genotype 1 and 4 patients, sustained response increased with higher ribavirin adherence over the second, third, and fourth 12-week intervals. Results were similar for interferon adherence. Mean adherence to interferon and ribavirin decreased 3.4% and 6.6% per 12-week interval, respectively (test for trend, p<0.001 for each drug). Patients prescribed growth factors or thyroid medications during treatment had higher mean antiviral adherence. Observational study without standardized timing for outcomes measurements. Early and sustained virologic responses increased with higher levels of adherence to interferon and ribavirin. Adherence to both antivirals declined over time, but more so for ribavirin.
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