Population Pharmacokinetic and Pharmacodynamic Analysis To Evaluate a Switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in People Living with HIV-1

Antimicrob Agents Chemother. 2020 Oct 20;64(11):e00590-20. doi: 10.1128/AAC.00590-20. Print 2020 Oct 20.

Abstract

Doravirine is a non-nucleoside reverse transcriptase inhibitor for treatment of human immunodeficiency virus type 1 (HIV-1) infection. A population pharmacokinetic (PK) model for treatment-naive participants in doravirine clinical studies was updated with data from switch participants in the DRIVE-SHIFT trial and used to estimate individual post hoc PK parameter values and evaluate the efficacy exposure-response relationship. The results support the 100-mg dose for people living with HIV switching to a doravirine-based regimen (This study has been registered at ClinicalTrials.gov under ClinicalTrials registration no. NCT02397096.).

Keywords: doravirine; fixed-dose combination; non-nucleoside reverse transcriptase inhibitor; population pharmacokinetic model; switch treatment.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-HIV Agents* / therapeutic use
  • Emtricitabine / therapeutic use
  • Fumarates
  • HIV Infections* / drug therapy
  • HIV-1*
  • Humans
  • Lamivudine / therapeutic use
  • Pyridones
  • Tenofovir / therapeutic use
  • Triazoles

Substances

  • Anti-HIV Agents
  • Fumarates
  • Pyridones
  • Triazoles
  • Lamivudine
  • doravirine
  • Tenofovir
  • Emtricitabine

Associated data

  • ClinicalTrials.gov/NCT02397096