The effects of boceprevir and telaprevir on the pharmacokinetics of maraviroc: an open-label, fixed-sequence study in healthy volunteers

Journal of Acquired Immune Deficiency Syndromes : JAIDS
Manoli VourvahisJayvant Heera

Abstract

To evaluate the effects of boceprevir (BOC) and telaprevir (TVR) on the pharmacokinetics (PK) of maraviroc (MVC) in healthy volunteers. In this open-label, fixed-sequence study, 14 volunteers received MVC 150 mg twice daily alone for 5 days (period 1), followed by MVC + BOC 800 mg 3 times daily and MVC + TVR 750 mg 3 times daily, each for 10 days in periods 2 and 3, respectively, with a ≥10-day wash-out. PK was analyzed on day 5 of period 1 and day 10 of periods 2 and 3. Safety was also assessed. Ratios of the adjusted geometric means (90% confidence intervals) for MVC area under the curve from predose to 12 hours, maximum plasma concentration, and plasma concentration at 12 hours were 3.02 (2.53 to 3.59), 3.33 (2.54 to 4.36), and 2.78 (2.40 to 3.23), respectively, for MVC + BOC versus MVC alone, and 9.49 (7.94 to 11.34), 7.81 (5.92 to 10.32), and 10.17 (8.73 to 11.85), respectively, for MVC + TVR versus MVC alone. PK profiles for MVC + BOC or TVR were consistent with historic values for BOC and TVR monotherapy. Adverse event incidence was higher with MVC + BOC and MVC + TVR versus MVC alone. Dysgeusia (50%) and pruritus (29%) occurred most commonly with MVC + BOC, and fatigue (46%) and headache (31%) with MVC + TVR. There were...Continue Reading

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Citations

Nov 26, 2013·Current HIV/AIDS Reports·Cody A Chastain, Susanna Naggie
Jun 24, 2014·Enfermedades infecciosas y microbiología clínica·UNKNOWN Panel de expertos de GeSIDA, UNKNOWN Plan Nacional sobre el Sida
Jul 8, 2016·Journal of Clinical Pharmacology·Mitesh PatelMaciej J Zamek-Gliszczynski
Apr 2, 2020·Expert Opinion on Drug Metabolism & Toxicology·Ravindra V AlluriManthena V S Varma

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Methods Mentioned

BETA
contraception

Clinical Trials Mentioned

NCT01597895
NCT01327547

Software Mentioned

eNCA

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