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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

  • 1,
  • 2,
  • 3,
  • 4,
  • 5,
  • 6,
  • 6 and
  • 6
Journal of the International AIDS Society201013 (Suppl 4) :P3

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

  • Published:

Keywords

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

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

 

DRV/r

 

LPV/r

 

DRV/r-LPV/r [95% CI]

 

N

%

N

%

 

VL <50cpm (ITT-TLOVR)

     

All patients

343

68.8

346

57.2

11.6 [4.4-18.8]

BL VL <100,000

226

69.5

226

60.2

9.3 [0.5-18.1]

BL VL ≥100,000

117

67.5

120

51.7

15.9 [3.5-28.3]

BL CD4 <200

141

65.2

148

54.1

11.2 [-0.1-22.5]

BL CD4 ≥200

202

71.3

198

59.6

11.7 [2.4-21.0]

VL <50cpm (sensitivity analyses)

     

TLOVR non-VF censored

270

87.4

245

80.8

6.6 [0.3-12.9]

On protocol TLOVR

340

69.1

345

57.1

12.0 [4.8-19.2]

Missing=failure

343

68.5

346

60.1

8.4 [1.3-15.5]

FDA snapshot

343

68.5

346

59.8

8.7 [1.5-15.8]

Treatment-emergent adverse events (AEs)

     

AEs leading to permanent stop of study medication

343

7.6

346

14.5

p=0.005*

Grade 2-4 treatment-related diarrhoea

343

5.0

346

11.3

p=0.003*

Changes in lipid parameters, median increase mmol/L (min; max)

     

Triglycerides

254

0.1 (-5; 3)

228

0.6 (-3; 10)

p<0.0001

Total cholesterol§

254

0.6 (-2; 4)

228

1.0 (-1; 4)

p<0.0001

*Fisher's Exact test; NCEP normal level <1.69mmol/L; §NCEP normal level <5.17mmol/L; Wilcoxon Rank Sum test

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.

Authors’ Affiliations

(1)
Barts and The London NHS Trust, London, UK
(2)
Orlando Immunology Center, Orlando, USA
(3)
AIDS Healthcare Foundation, Los Angeles, USA
(4)
Institute for Interdisciplinary Medicine, Hamburg, Germany
(5)
Chiang Mai University, Chiang Mai, Thailand
(6)
Tibotec BVBA, Beerse, Belgium

Copyright

© Orkin et al; licensee BioMed Central Ltd. 2010

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.

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