Doyle Mary-Anne, Lee Terry, Singer Joel, Crawley Angela, Klein Marina, Cooper Curtis
Division of Endocrinology and Metabolism, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Open Forum Infect Dis. 2019 Jul 1;6(7). doi: 10.1093/ofid/ofz318.
We conducted a pilot study assessing the feasibility, efficacy, and safety of a simplified combination HIV antiretroviral and hepatitis C virus (HCV) antiviral regimen in HIV-HCV coinfection.
Participants on suppressive antiretrovirals and HCV genotype 1 infection were switched to single-tablet daily-dosed elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) and 1 month later initiated single-tablet-regimen daily-dosed ledipasvir-sofosbuvir for 12 weeks. E/C/F/TAF was continued during HCV treatment and for 12 weeks after.
Twenty-six individuals were screened, 25 enrolled, and 23 completed all HIV and HCV treatment. Participants were predominantly male, with a mean age (SD) of 55 (7.5) years. The median transient elastography score (interquartile range [IQR]) was 5.9 (5.3 to 7.6) kPa, and the mean CD4 count (SD) was 579 (223) cells/µL. The median adherence to HCV medications, assessed by pill count, was 100% (95% confidence interval [CI], 100%-100%), and HIV ranged from 99% to 100% (100%; 95% CI, 90%-100%) over the 7-month study duration. HIV undetectability was maintained in all but 1 participant enrolled with unsuspected multiclass resistance. Treatment was well tolerated, with no study medication modification due to adverse events and no serious adverse event related to the study drug. All participants achieved sustained virological response. The mean CD4 count (SD) increased to 673 (361) cells/µL, and the fibrosis score (IQR) declined to 5.2 (4.4 to 7.4) kPa by week 12 after HCV treatment. There was no treatment effect on glucose metabolism. Cholesterol increased during and after treatment.
Provision of this 2-tablet daily HIV-HCV regimen is feasible, well tolerated, and safe, avoids drug-drug interactions between HIV and HCV medications, maintains HIV suppression in the absence of drug resistance, and is highly curative of HCV.
我们开展了一项初步研究，评估一种简化的联合抗人类免疫缺陷病毒（HIV）和抗丙型肝炎病毒（HCV）抗病毒方案在HIV-HCV合并感染中的可行性、疗效和安全性。
正在接受抑制性抗逆转录病毒治疗且感染HCV 1型的参与者换用每日一次单一片剂的艾维雷韦/考比司他/恩曲他滨/替诺福韦艾拉酚胺（E/C/F/TAF），1个月后开始每日一次单一片剂方案的来迪派韦-索磷布韦治疗，疗程为12周。在HCV治疗期间及之后12周继续使用E/C/F/TAF。
共筛查26人，25人入组，23人完成了所有HIV和HCV治疗。参与者以男性为主，平均年龄（标准差）为55（7.5）岁。瞬时弹性成像评分中位数（四分位间距[IQR]）为5.9（5.3至7.6）kPa，平均CD4细胞计数（标准差）为579（223）个/µL。通过药丸计数评估，HCV药物的依从性中位数为100%（95%置信区间[CI]，100%-100%），在7个月的研究期间，HIV的依从性为99%至100%（100%；95%CI，90%-100%）。除1名入组时未被怀疑有多类耐药的参与者外，所有参与者的HIV均未被检测到。治疗耐受性良好，未因不良事件而调整研究药物，也没有与研究药物相关的严重不良事件。所有参与者均实现了持续病毒学应答。HCV治疗后第12周，平均CD4细胞计数（标准差）增至673（361）个/µL，纤维化评分（IQR）降至5.2（4.4至7.4）kPa。对糖代谢无治疗效果。治疗期间及治疗后胆固醇升高。
提供这种每日两片的HIV-HCV方案是可行的、耐受性良好且安全的，可避免HIV和HCV药物之间的药物相互作用，在无耐药的情况下维持HIV抑制，并且对HCV具有高度治愈性。
