尽管聚乙二醇干扰素/利巴韦林联合治疗丙型肝炎中服药依从性的重要性是公认的，但现实中这方面相关数据却很少。这些信息可能有助于临床医生提高病人依从性，从而提高干扰素联合利巴韦林的的病毒学应答。这同样也使用于新的抗病毒药物的应用。在这项前瞻性多中心研究中，来自德国42个中心的746例采用聚乙二醇干扰素α-2b 1.5ug/kg/wk联合剂量依赖的利巴韦林（800-1200 mg/day ）的初治HCV患者，接受了48周的治疗。将两种药物分别的使用量和用药时间均大于等于80%作为依从性的分类标准。用多因素Logistic回归分析来确定预测HCV治疗依从性的的因素。持续病毒学应答被定义为治疗结束后24周检测不到血清中HCV-RNA。病人的平均年龄为43岁，40%为女性，3%合并HIV。病毒基因型分布如下：1型占62%；2型占6%；3型占28%，4型占3%，其他型占1%。1/4型和2/3型总SVR率分别为47.1%和59.9%。按依从性好差分组后分别为76.5%/74.9% 和 22.5%/28.6% 。为了确定与依从性相关的非病毒学因素，采用了多元回归模型：药物相关的副作用(OR2.02, p=0.008)及曾被建议进行心理治疗(OR0.476, p<0.013)与依从性的好差独立相关。其他因素：如治疗前干扰素笔芯的具体演示，电话联系主治医生的次数，低毒药品或酒精的用量，医师的治疗经验均与依从性无明显相关性。结论：提高HCV治疗的依从性能够增加SVR。药物副作用与高依从性相关。精神科诊断的存在降低了依从性，但随着成长经历的增加可得到改善。
吉林大学第一医院肝胆胰内科 孙海波 摘译
Patient Adherence: the Influence of Non-virological Factors in a Real Word Setting
Background: Only few data are available on adherence to combination HCV therapy with pegylated interferon (PegIFN)/ribavirin (RBV) in real-world settings, despite its acknowledged importance. Such information might help clinicians to improve adherence and thereby virologic response to PegIFN/RBV therapy, also in combination with new antivirals.Methods:In this prospective observational multicenter study (adhere study) 746 treatment-naïve patients with chronic HCV infection were treated with PegIFN alfa-2b 1.5 µg/kg/wk + weight-based RBV (800-1200 mg/day) for up to 48 wks at 42 sites in Germany. Patients who received at least 80% of each of the 2 medications for at least 80% of the expected duration of therapy were classified as adherent. Multivariate logistic regression was used to determine factors predicting adherence to HCV treatment. SVR was defined as undetectable serum HCV-RNA 24 wks after end of treatment.Results: Median age of patients was 43 years, 40% were female, 3% had HIV co-infection and HCV genotypes (G) were distributed as follows: G1 62%, G2 6%, G3 28%, G4 3%, other 1%. Overall SVR rates were 47.1% and 59.9%.for G1/4 and G2/3 infection in contrast to 76.5%/74.9% and 22.5%/28.6% in adherent/non-adherent patients , respectively. In a multivariate logistic regression model to determine non-virological factors associated with adherence, drug-related adverse events (odds ratio 2.02, p=0.008) and recommended supportive psychotherapy (odds ratio 0.476, p<0.013) were independently associated with a higher/lower likelihood of adherence. Other factors such as detailed demonstration of PegIFN alfa-2b pen device before therapy (odds ratio 0.99, p=0.33), number of telephone contacts with the treating physician (odds ratio 1.11, p=019), consumption of soft drugs (odds ratio 0.67,p=0.16) or alcohol (odds ratio 0.55, p=0.10) and the experience of physicians by number of HCV patients treated per year (odds ratio 0.99, p=0.24) were not significantly associated with adherence.Conclusions: Adherence to HCV treatment increases the likelihood of SVR. Drug-related adverse events are associated with high adherence. Presence of a psychiatric diagnosis lowers adherence but may be modifiable with growing experience.
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