Lack of pharmacokinetic interaction between rilpivirine and integrase inhibitors dolutegravir and GSK1265744

Antimicrob Agents Chemother. 2013 Nov;57(11):5472-7. doi: 10.1128/AAC.01235-13. Epub 2013 Aug 26.

Abstract

Dolutegravir (DTG) and GSK1265744 are HIV integrase inhibitors (INIs) in clinical development. The oral formulation of rilpivirine (RPV), a nonnucleoside reverse transcriptase inhibitor (NNRTI), has been approved for treatment-naive HIV infection. Long-acting depot injections of GSK1265744 and RPV are also being developed. This study evaluated the potential for drug interactions between RPV and these INIs. This phase 1, open-label, two-cohort, three-period, single-sequence crossover study evaluated oral coadministration of RPV with DTG or GSK1265744. Healthy subjects received DTG (50 mg every 24 h for 5 days) or GSK1265744 (30 mg every 24 h for 12 days) in period 1 followed by a washout, RPV (25 mg every 24 h for 11 or 12 days) in period 2, immediately followed by RPV (25 mg every 24 h) plus DTG (50 mg every 24 h) for 5 days or GSK1265744 (30 mg every 24 h) for 12 days in period 3. Steady-state pharmacokinetic (PK) parameters were estimated using noncompartmental analysis of data collected on the last day of each period. The combinations of RPV and DTG (n = 16) and of RPV and GSK1265744 (n = 11) were well tolerated; no grade 3 or 4 adverse events (AEs) or AE-related discontinuations were observed. The 90% confidence intervals for the area under the curve from time zero until the end of the dosage interval [AUC0-τ] and maximum concentration of drug in serum (Cmax) geometric mean ratios were within 0.8 to 1.25. Following administration of DTG + RPV, DTG and RPV Cτ increased by 22% and 21%, respectively. Following administration of GSK1265744 + RPV, RPV Cτ decreased 8%. DTG and GSK1265744 can be administered with RPV without dosage adjustment for either agent. These results support coadministration of RPV with DTG or GSK1265744 as either oral or long-acting depot injection regimens. (This study has been registered at ClinicalTrials.gov under registration no. NCT01467531.).

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Area Under Curve
  • Cross-Over Studies
  • Drug Administration Schedule
  • Drug Combinations
  • Drug Interactions
  • Female
  • HIV Integrase Inhibitors / blood
  • HIV Integrase Inhibitors / pharmacokinetics*
  • Healthy Volunteers
  • Heterocyclic Compounds, 3-Ring / blood
  • Heterocyclic Compounds, 3-Ring / pharmacokinetics*
  • Humans
  • Male
  • Middle Aged
  • Nitriles / blood
  • Nitriles / pharmacokinetics*
  • Oxazines
  • Piperazines
  • Pyridones / blood
  • Pyridones / pharmacokinetics*
  • Pyrimidines / blood
  • Pyrimidines / pharmacokinetics*
  • Reverse Transcriptase Inhibitors / blood
  • Reverse Transcriptase Inhibitors / pharmacokinetics*
  • Rilpivirine

Substances

  • Drug Combinations
  • HIV Integrase Inhibitors
  • Heterocyclic Compounds, 3-Ring
  • Nitriles
  • Oxazines
  • Piperazines
  • Pyridones
  • Pyrimidines
  • Reverse Transcriptase Inhibitors
  • dolutegravir
  • Rilpivirine
  • cabotegravir

Associated data

  • ClinicalTrials.gov/NCT01467531