Switching to darunavir/ritonavir 800/100mg once-daily containing regimen maintains virological control in fully suppressed pre-treated patients infected with HIV-1

Jade Ghosn*, Laurence Slama, Aziza Chermak, Allal Houssaini, Sidonie Lambert-Niclot, Luminita Schneider, Erwan Fourn, Claudine Duvivier, Anne Simon, Eve Courbon, Robert Murphy, Philippe Flandre, Gilles Peytavin, Christine Katlama, Anne Genevieve Marcelin, Vincent Calvez, Marc Antoine Valantin, Gilles Pialoux, Jean Francois Delfraissy, Serge HersonFrancois Bricaire, Olivier Lortholary, Francois Lecardonnel, Michele Pauchard, Patricia Bourse, Martine Mole, Anne Adda, Fatima Touam, Francoise Pochon, Fabien Sordet, Diane Descamps, France Mentre, Jean Marie Poirie, Caroline Lascoux-Combe

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

The objective of this study was to evaluate the switch to once-daily darunavir/ritonavir 800/100mg in treatment-experienced patients with suppressed HIV-1 replication on a twice-daily ritonavir-boosted protease-inhibitor (bid PI/r) containing regimen, that is in a setting where genotypic resistance test cannot be performed. In this open label, non-comparative, multicenter study, patients on a bid PI/r-containing triple combination, with suppressed viral replication, were switched to once-daily darunavir/r 800/100mg containing triple combination. The primary endpoint was the proportion of patients with plasma HIV-RNA<50copies/ml 24 weeks after the switch. Intensive darunavir pharmacokinetic evaluation was performed at Week 4 (W4) in 11 patients. Eighty-five patients were enrolled. All had HIV-RNA<50copies/ml at screening with a pre-exposure to a median of 2 PI/r (1-5). By intent-to-treat analysis (missing=failure), 78/85 patients (92%, 95% CI [83;96]) maintained an HIV-RNA<50copies/ml at W24. Seven patients experienced protocol-defined treatment failure between baseline and W24: Two had confirmed low-level viral rebound, one discontinued study treatment for adverse event, three withdrew their consent, and one was lost to follow-up. By on-treatment analysis, 78/80 patients (97%, 95% CI [91;99]) maintained an HIV-RNA<50copies/ml at W24. Results were similar at Week 48. The median area under the darunavir plasma concentration-time curve measured in 11 patients was 61,380nghr/ml; darunavir median trough concentration 1,340ng/ml and darunavir half-life was 12.2hr. Tolerability of once-daily darunavir/r 800/100mg was excellent. Optimally suppressed, treatment-experienced patients can switch safely from a twice-daily PI/r regimen to a once-daily darunavir/r 800/100mg containing regimen.

Original languageEnglish (US)
Pages (from-to)8-15
Number of pages8
JournalJournal of Medical Virology
Volume85
Issue number1
DOIs
StatePublished - Jan 1 2013

Keywords

  • Free fraction
  • HIV-1
  • Once-daily
  • Protease inhibitors
  • Semen
  • Simplification

ASJC Scopus subject areas

  • Virology
  • Infectious Diseases

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