Your browser doesn't support javascript.
loading
Pharmacokinetic interaction between etravirine or rilpivirine and telaprevir in healthy volunteers: A randomized, two-way crossover trial.
Kakuda, Thomas N; Leopold, Lorant; Nijs, Steven; Vandevoorde, Ann; Crauwels, Herta M; Bertelsen, Kirk M; Stevens, Marita; Witek, James; van Delft, Yvon; Tomaka, Frank; Hoetelmans, Richard M W.
Afiliação
  • Kakuda TN; Janssen Research and Development, LLC, Titusville, NJ, USA.
  • Leopold L; Janssen Research and Development, LLC, Titusville, NJ, USA.
  • Nijs S; Janssen Infectious Diseases BVBA, Beerse, Belgium.
  • Vandevoorde A; Janssen Infectious Diseases BVBA, Beerse, Belgium.
  • Crauwels HM; Janssen Infectious Diseases BVBA, Beerse, Belgium.
  • Bertelsen KM; Janssen Research and Development, LLC, Titusville, NJ, USA.
  • Stevens M; Janssen Infectious Diseases BVBA, Beerse, Belgium.
  • Witek J; Janssen Research and Development, LLC, Titusville, NJ, USA.
  • van Delft Y; Janssen, Tilburg, The Netherlands.
  • Tomaka F; Janssen Research and Development, LLC, Titusville, NJ, USA.
  • Hoetelmans RM; Janssen Infectious Diseases BVBA, Beerse, Belgium.
J Clin Pharmacol ; 54(5): 563-73, 2014 May.
Article em En | MEDLINE | ID: mdl-25975423
Coinfection with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) may require treatment with an HIV non-nucleoside reverse transcriptase inhibitor (NNRTI), for example, rilpivirine or etravirine, and an HCV direct-acting antiviral drug such as telaprevir. In a two-panel, two-way, crossover study, healthy volunteers were randomized to receive etravirine 200 mg twice daily ± telaprevir 750 mg every 8 hours or rilpivirine 25 mg once daily ± telaprevir 750 mg every 8 hours. Pharmacokinetic assessments were conducted for each drug at steady-state when given alone and when coadministered; statistical analyses were least-square means with 90% confidence intervals. Telaprevir minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the concentration-time curve (AUC) decreased 25%, 10%, and 16%, respectively, when coadministered with etravirine and 11%, 3%, and 5%, respectively, when coadministered with rilpivirine. Telaprevir did not affect etravirine pharmacokinetics, but increased rilpivirine Cmin, Cmax, and AUC by 93%, 49%, and 78%, respectively. Both combinations were generally well tolerated. The small decrease in telaprevir exposure when coadministered with etravirine is unlikely to be clinically relevant. The interaction between telaprevir and rilpivirine is not likely to be clinically relevant under most circumstances. No dose adjustments are deemed necessary when they are coadministered.
Assuntos
Palavras-chave

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Oligopeptídeos / Piridazinas / Pirimidinas / Inibidores da Transcriptase Reversa / Fármacos Anti-HIV / Nitrilas Tipo de estudo: Clinical_trials Idioma: En Revista: J Clin Pharmacol Ano de publicação: 2014 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Oligopeptídeos / Piridazinas / Pirimidinas / Inibidores da Transcriptase Reversa / Fármacos Anti-HIV / Nitrilas Tipo de estudo: Clinical_trials Idioma: En Revista: J Clin Pharmacol Ano de publicação: 2014 Tipo de documento: Article