1. No Pharmacokinetic Interactions Between Elbasvir or Grazoprevir and Buprenorphine/Naloxone in Healthy Participants and Participants Receiving Stable Opioid Agonist Therapy.
- Author
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Feng, Hwa‐Ping, Guo, Zifang, Caro, Luzelena, Marshall, William L., Liu, Fang, Panebianco, Deborah, Vaddady, Pavan, Barbour, April, Reitmann, Christina, Jumes, Patricia, Gilmartin, Jocelyn, Wolford, Dennis, Valesky, Robert, Martinho, Monika, Butterton, Joan R., Iwamoto, Marian, Fraser, Iain, Webster, Lynn, and Yeh, Wendy W.
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PHARMACOKINETICS , *OPIOID receptors , *CLINICAL drug trials , *HEPATITIS C treatment , *HEPATITIS C virus , *PHARMACEUTICAL research - Abstract
The aims of these phase I trials were to evaluate the pharmacokinetic interaction between elbasvir (EBR) or grazoprevir (GZR) and buprenorphine/naloxone (BUP/NAL). Trial 1 was a single‐dose trial in healthy participants. Trial 2 was a multiple‐dose trial in participants on BUP/NAL maintenance therapy. Coadministration of EBR or GZR with BUP/NAL had minimal effect on the pharmacokinetics of BUP/NAL, EBR, and GZR. The geometric mean ratios (GMRs (90% CI)) for BUP, norbuprenorphine, and NAL AUC0‐∞ were 0.98 (0.89–1.08), 0.97 (0.86–1.09), and 0.88 (0.78–1.00) in the presence/absence of EBR; 0.98 (0.81–1.19), 1.13 (0.97–1.32), and 1.10 (0.82–1.47) in the presence/absence of GZR. The GMRs (90% CI) for EBR and GZR AUC0‐∞ in the absence/presence of BUP/NAL were 1.22 (0.98–1.52) and 0.86 (0.63–1.18). In conclusion, no dose adjustment for BUP/NAL, EBR, or GZR is required for patients with HCV infection receiving EBR/GZR and BUP/NAL maintenance therapy. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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