Week 24 efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients

Richard Haubrich, Dan Berger, Philippe Chiliade, Amy Colson, Marcus Conant, Joel Gallant, Timothy Wilkin, Jeffrey Nadler, Gerald Pierone, Michael Saag, Ben Van Baelen, Eric Lefebvre

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Agents for the treatment of HIV-1-infected patients with resistance to current antiretroviral (ART) drugs are needed. METHODS: TMC114-C202 was a randomized, partially blinded, dose-finding study in treatment-experienced HIV-1-infected patients with one or more primary protease inhibitor (PI) mutations and HIV-1 RNA > 1000 copies/ml. Patients were randomized to receive one of four TMC114 doses given with ritonavir (TMC114/r) or investigator-selected control PI drug(s) (CPI); all received an optimized background regimen. The primary intent-to-treat analysis compared the proportion of patients achieving a ≥1 log10 copies/ml HIV-1 RNA reduction at week 24 between the treatment arms using the time-to-loss of virological response algorithm. RESULTS: For 278 patients at baseline, mean HIV-1 RNA was 4.7 log10 copies/ml, median CD4 cell count was 106 cells/μl; HIV-1 isolates had a median of three primary PI mutations and a median fold change in lopinavir susceptibility of 80. Discontinuation rates were 23% for TMC114/r versus 64% for CPI. More patients in each TMC114/r dose group achieved ≥1.0 log10 copies/ml reduction in HIV-1 RNA than in the CPI group (45-62% versus 14%; P ≤ 0.003): patients taking TMC114/r twice daily had the greatest responses. HIV-1 RNA was <50 copies/ml in 18-39% of TMC114/r patients versus 7% CPI (P <0.001 for highest dose). Mean CD4 cell count increased by 59-75 versus 12 cells/μl (TMC114/r versus CPI: P ≤ 0.005). Overall adverse event rates were similar in both arms, without significant differences among TMC114/r groups. CONCLUSIONS: TMC114/r treatment resulted in greater virological and immunological responses in ART-experienced patients compared with CPI at 24 weeks.

Original languageEnglish (US)
JournalAIDS
Volume21
Issue number6
DOIs
StatePublished - Mar 2007

Keywords

  • Darunavir
  • Efficacy
  • HIV
  • Protease inhibitor
  • Safety
  • TMC114
  • Treatment-experienced

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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