Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir.
Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir.
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HIV共同感染对使用Ledipasvir和Sofosbuvir的丙型肝炎病毒治疗的12周疗法的影响。
DOI：
10.1097/qad.0000000000000903
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发表时间：
2016-01
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由于丙型肝炎病毒(丙型肝炎病毒)感染的治疗已演变为直接作用的抗病毒药物，这些直接作用的仅抗病毒方案在改善艾滋病毒/丙型肝炎病毒混合感染人群中遵守丙型肝炎病毒治疗方面的影响尚未得到评估。这项研究比较了丙型肝炎病毒单一感染者和艾滋病毒/丙型肝炎病毒混合感染者对来地帕韦/索布韦(LDV/SOF)的依从性。依从性是由两个阶段2开放标签研究(NCT01805882和NCT01878799)的参与者测量的。未接受丙型肝炎病毒治疗的1型研究对象[丙型肝炎病毒单一感染者(N=20人)和HIV/丙型肝炎病毒混合感染者(未接受抗逆转录病毒治疗者(N=13人)或联合抗逆转录病毒治疗者(N=37人)]接受LDV(90 Mg)和SOF(400 Mg)治疗，每日一次，共12周。依从性使用三个工具来衡量：用药事件监测系统帽、药片计数和患者报告。参与者主要是非洲裔美国人(83%)和男性(73%)，年龄中值为59岁。受试者丙型肝炎病毒载量迅速下降，依从率高(用药事件监测系统为97±0.5%)。与治疗晚期(第8-12周)相比，所有三组患者的依从性从治疗早期(基线4周)开始显著下降(P=0.01)，包括单一感染的丙型肝炎病毒(P=0.01)、未经治疗的艾滋病毒/丙型肝炎病毒(P=0.02)和接受抗逆转录病毒治疗的患者(P=0.01)。无论是否使用抗逆转录病毒药物，这些城市人群对LDV/SOF的依从性很高，无论是否使用抗逆转录病毒药物，丙型肝炎病毒单一感染者和HIV/丙型肝炎病毒混合感染者的依从性相当。
As the treatment of hepatitis C virus (HCV) infection has evolved to directly acting antiviral agents, the impact of these directly acting antiviral-only regimens on improving adherence to HCV treatment in HIV/HCV coinfected populations has not been evaluated. The study compared adherence to ledipasvir/sofosbuvir (LDV/SOF) in HCV monoinfected and HIV/HCV coinfected individuals. Adherence was measured from participants in two phase 2 open-label studies (NCT01805882 and NCT01878799). HCV treatment-naive, genotype 1 study individuals [HCV monoinfected participants (N = 20) and HIV/HCV coinfected participants, antiretroviral untreated (N = 13) or on combination antiretroviral therapy (N = 37)] were treated with LDV (90 mg) and SOF (400 mg) administered as one tablet once daily for 12 weeks. Adherence was measured using three tools: medication event monitoring system cap, pill count, and patient report. Participants were predominately African American (83%) and male (73%), with a median age of 59 years. Participants had prompt HCV viral load decline and high adherence rates (97 ± 0.5% by medication event monitoring system). Participant adherence decreased significantly from early (baseline week 4) as compared with late (weeks 8–12) in therapy in all three groups - HCV monoinfected (P = 0.01), HIV/HCV antiretroviral untreated (P = 0.02), and HIV/HCV antiretroviral treated participants (P = 0.01). Adherence to LDV/SOF in this urban population was high and comparable between HCV monoinfected and HIV/HCV coinfected participants regardless of antiretroviral use.