Safety, tolerability, and efficacy of darunavir (TMC114) with low-dose ritonavir in treatment-experienced, hepatitis B or C co-infected patients in POWER 1 and 3

Anita Rachlis*, Bonaventura Clotet, John Baxter, Robert Murphy, Eric Lefebvre

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

34 Scopus citations

Abstract

Purpose: This subanalysis examines the safety and efficacy of darunavir with low-dose ritonavir (DRV/r) in hepatitis B or C virus (HBV or HCV) co-infected patients in POWER 1 and 3 trials. Method: POWER 1 and 3 enrolled treatment-experienced, HIV-infected patients with ≥1 primary protease inhibitor (PI) mutation and HIV-1 RNA >1,000 copies/mL. All patients received an optimized background regimen plus either control PI (almost all ritonavir boosted) or one of four DRV/r doses (POWER 1) or DRV/r 600/100 mg bid (POWER 3). Patients with active HBV or HCV co-infection who did not require treatment for hepatitis were included. Safety parameters were evaluated. Results: Of 634 DRV/r and 63 control (97% ritonavir boosted) patients assessed, 13% and 16%, respectively, had active co-infection. In both groups, more patients with active co-infection than without co-infection had liver-related adverse events (AEs). These AEs were mainly asymptomatic liver transaminase elevations, although changes were slightly less in the DRV/r group (DRV/r, 13% vs. 8%; control PI, 20% vs. 12%). Only two patients (one per treatment arm) discontinued therapy due to grade 3 or 4 alanine and aspartate transaminase elevations. Conclusion: DRV/r was generally well tolerated in treatment-experienced, HBV or HCV co-infected patients. No differences in liver-related AEs were observed between treatment groups.

Original languageEnglish (US)
Pages (from-to)213-220
Number of pages8
JournalHIV Clinical Trials
Volume8
Issue number4
DOIs
StatePublished - Jul 2007

Keywords

  • Darunavir
  • HBV
  • HCV
  • HIV-1
  • Hepatitis
  • TMC114

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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