在一项2a期研究中，城市中心患者群体对全口服直接作用抗病毒丙肝治疗的高依从性。
High adherence to all-oral directly acting antiviral HCV therapy among an inner-city patient population in a phase 2a study.
作者信息
Petersen Tess, Townsend Kerry, Gordon Lori A, Sidharthan Sreetha, Silk Rachel, Nelson Amy, Gross Chloe, Calderón Monica, Proschan Michael, Osinusi Anu, Polis Michael A, Masur Henry, Kottilil Shyam, Kohli Anita
机构信息
Critical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
出版信息
Hepatol Int. 2016 Mar;10(2):310-9. doi: 10.1007/s12072-015-9680-7. Epub 2015 Nov 26.
BACKGROUND
As treatment for chronic hepatitis C (HCV) virus has evolved to all-oral, interferon-free directly acting antiviral (DAA) therapy, the impact of these improvements on patient adherence has not been described.
METHODS
Medication adherence was measured in 60 HCV, genotype-1, treatment-naïve participants enrolled in a phase 2a clinical trial at the National Institutes of Health and community clinics. Participants received either ledipasvir/sofosbuvir (LDV/SOF) (90 mg/400 mg) (one pill) daily for 12 weeks, LDV/SOF + GS-9451 (80 mg/day) (two pills) daily for 6 weeks, or LDV/SOF + GS-9669 (500 mg twice daily; three pills, two in the morning, one in the evening) for 6 weeks. Adherence was measured using medication event monitoring system (MEMS) caps, pill counts and patient report.
RESULTS
Overall adherence to DAAs was high. Adherence declined over the course of the 12-week treatment (p = 0.04). While controlled psychiatric disease or symptoms of depression did not influence adherence, recent drug use was a risk factor for non-adherence to 12-week (p = 0.01), but not 6-week regimens. Adherence as measured by MEMS was lower than by patient report.
CONCLUSIONS
Adherence to short courses of DAA therapy with 1-3 pills a day was excellent in an urban population with multiple risk factors for non-adherence.
背景
随着慢性丙型肝炎（HCV）病毒的治疗已发展为全口服、无干扰素的直接抗病毒（DAA）疗法，这些改进对患者依从性的影响尚未得到描述。
方法
对在美国国立卫生研究院和社区诊所参加2a期临床试验的60名未经治疗的HCV基因1型参与者的药物依从性进行了测量。参与者接受以下治疗：每日一次口服来迪派韦/索磷布韦（LDV/SOF）（90毫克/400毫克）（一片），持续12周；每日一次口服LDV/SOF + GS-9451（80毫克/天）（两片），持续6周；或每日两次口服LDV/SOF + GS-9669（500毫克；三片，早上两片，晚上一片），持续6周。使用药物事件监测系统（MEMS）瓶盖、药片计数和患者报告来测量依从性。
结果
对DAA的总体依从性较高。在12周的治疗过程中依从性有所下降（p = 0.04）。虽然受控的精神疾病或抑郁症状不影响依从性，但近期吸毒是不依从12周治疗方案的一个风险因素（p = 0.01），但不是6周治疗方案的风险因素。通过MEMS测量的依从性低于患者报告的依从性。
结论
在有多种不依从风险因素的城市人群中，每天服用1 - 3片的短疗程DAA治疗的依从性良好。
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