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Title : EBR/GZR safe/effective for people with HCV receiving opioid agonist therapy
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EBR/GZR safe/effective for people with HCV receiving opioid agonist therapy

Clin Transl Sci. 2018 Jul 24. doi: 10.1111/cts.12564. [Epub ahead of print]

No Pharmacokinetic Interactions Between Elbasvir or Grazoprevir and Methadone in Participants Receiving Maintenance Opioid Agonist Therapy

Feng HP1, Guo Z1, Caro L1, Marshall WL1,2, Liu F1, Panebianco D1, Vaddady P1, Reitmann C1, Jumes P1, Wolford D1, Fraser I1,3, Valesky R1, Martinho M1, Butterton JR1, Iwamoto M1, Webster L4,5, Yeh WW1.

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Abstract
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 AUC0-24 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 AUC0-24 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. PMID: 30040872 DOI: 10.1111/cts.12564

Continue to article: https://ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.12564

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