在接受维持阿片类激动剂治疗的参与者中，艾尔巴韦格拉瑞韦与美沙酮之间无药代动力学相互作用。
No Pharmacokinetic Interactions Between Elbasvir or Grazoprevir and Methadone in Participants Receiving Maintenance Opioid Agonist Therapy.
机构信息
Merck & Co., Inc., Kenilworth, New Jersey, USA.
Alexion Pharmaceuticals, Inc., New Haven, Connecticut, USA.
出版信息
Clin Transl Sci. 2018 Nov;11(6):553-561. doi: 10.1111/cts.12564. Epub 2018 Jul 24.
We conducted two phase I trials to evaluate the pharmacokinetic interactions between elbasvir (EBR), grazoprevir (GZR), and methadone (MK-8742-P010 and MK-5172-P030) in non-hepatitis C virus (HCV)-infected participants on methadone maintenance therapy. Coadministration of EBR or GZR with methadone had no clinically meaningful effect on EBR, GZR, or methadone pharmacokinetics. The geometric mean ratios (GMRs) for R- and S-methadone AUC were 1.03 (90% confidence interval (CI), 0.92-1.15) and 1.09 (90% CI, 0.94-1.26) in the presence/absence of EBR; and 1.09 (90% CI, 1.02-1.17) and 1.23 (90% CI, 1.12-1.35) in the presence/absence of GZR. The GMRs for EBR and GZR AUC in participants receiving methadone relative to a healthy historical cohort not receiving methadone were 1.20 (90% CI, 0.94-1.53) and 1.03 (90% CI, 0.76-1.41), respectively. These results indicate that no dose adjustment is required for individuals with HCV infection receiving stable methadone therapy and the EBR/GZR fixed-dose regimen.
我们进行了两项 I 期临床试验，以评估在接受美沙酮维持治疗的非丙型肝炎病毒（HCV）感染参与者中，依巴司韦（EBR）、格拉瑞韦（GZR）和美沙酮（MK-8742-P010 和 MK-5172-P030）之间的药代动力学相互作用。EBR 或 GZR 与美沙酮联合用药对 EBR、GZR 或美沙酮的药代动力学无临床意义影响。存在/不存在 EBR 时，R-和 S-美沙酮 AUC 的几何均数比值（GMR）分别为 1.03（90%置信区间（CI），0.92-1.15）和 1.09（90% CI，0.94-1.26）；存在/不存在 GZR 时，分别为 1.09（90% CI，1.02-1.17）和 1.23（90% CI，1.12-1.35）。接受美沙酮治疗的参与者相对于未接受美沙酮治疗的健康历史队列中，EBR 和 GZR AUC 的 GMR 分别为 1.20（90% CI，0.94-1.53）和 1.03（90% CI，0.76-1.41）。这些结果表明，对于接受稳定美沙酮治疗且 EBR/GZR 固定剂量方案的 HCV 感染个体，无需调整剂量。
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