Skip to main content

ARTEMIS: 192-week efficacy and safety of once-daily darunavir/ritonavir (DRV/r) vs lopinavir/r (LPV/r) in treatment-naïve HIV-1-infected adults

Background

ARTEMIS was a Phase III, randomised, open-label study assessing efficacy and safety of DRV/r 800/100mg qd versus LPV/r 800/200mg total daily dose (qd or bid) in treatment-naïve HIV-1-infected adults. At 96 wks, DRV/r demonstrated non-inferiority and superiority to LPV/r in virological response. Wk 192 results are reported.

Methods

Patients stratified by baseline (BL) viral load (VL [HIV-1 RNA] < or ≥100,000 copies/mL [cpm]) and CD4 cell count (< or ≥200 cells/mm3) were randomised 1:1 to DRV/r qd or LPV/r. Primary efficacy parameter: non-inferiority (≤ –12%) of DRV/r to LPV/r in virological response (VL <50 cpm, ITT-TLOVR). DRV/r superiority ( ≤ 0%) was assessed if non-inferiority was demonstrated.

Results

689 patients (30% female; mean BL VL 4.85 log10 cpm; median CD4 225 cells/mm3) were randomised. Overall, significantly more DRV/r than LPV/r patients had VL <50 cpm at Wk 192, confirming DRV/r qd non-inferiority (p<0.001) and superiority (p=0.002) (Table 1). In patients with virological failure (VF; TLOVR non-VF censored) no developing primary PI mutations were identified in either arm; all VFs with paired BL/endpoint phenotypes that were susceptible at BL to amprenavir, atazanavir, indinavir, lopinavir, saquinavir or tipranavir remained susceptible after treatment.

Table 1

Conclusions

DRV/r qd demonstrated sustained efficacy with non-inferiority and superiority to LPV/r over 192 wks. Development of resistance was low in both arms. DRV/r was associated with smaller median increases in total cholesterol and triglycerides than LPV/r, and a lower incidence of grade 2–4 diarrhoea.

Author information

Authors and Affiliations

Authors

Rights and permissions

This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and Permissions

About this article

Cite this article

Orkin, C., DeJesus, E., Khanlou, H. et al. ARTEMIS: 192-week efficacy and safety of once-daily darunavir/ritonavir (DRV/r) vs lopinavir/r (LPV/r) in treatment-naïve HIV-1-infected adults. JIAS 13, P3 (2010). https://doi.org/10.1186/1758-2652-13-S4-P3

Download citation

  • Published:

  • DOI: https://doi.org/10.1186/1758-2652-13-S4-P3

Keywords

  • Virological Response
  • Indinavir
  • Saquinavir
  • Atazanavir
  • Virological Failure