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ARTEMIS: Efficacy and safety of lopinavir (BID vs QD) and darunavir (QD) in antiretroviral-naive patients
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Reported by Jules Levin
N Clumeck, J Van Lunzen, P Chiliade, B Clotet,
C Vanden Abeele, E Lefebvre, T Vangeneugden,
R DeMasi, S Spinosa-Guzman
ARTEMIS: Phase III study design
Multinational study, conducted across 26 countries
689 naives randomized to darunavir/r 800/100 once daily (n=343) or lopinavir/r 400/100 twice daily or 800/200mg once daily, plus tenofovir 300mg and FTC 200,g once daily (n=346
STUDY OBJECTIVES
Primary end point
--proportion of patients with an HIV RNA <50 copies/mL at Week 48 (ITT-TLOVR)
Primary objective
--demonstrate non-inferiority of DRV/r QD vs LPV/r (BID or QD) based on the primary endpoint
Secondary objective
--evaluate efficacy, safety and tolerability over 192 weeks
Analysis background and rationale
Previous findings in treatment-naive patients suggest that the efficacy of LPV/r is similar between the QD and BID dosing regimens1
Recent data from study ACTG 5073 showed LPV/r BID was more effective than LPV/r QD in treatment-naive patients with high baseline viral loads (≥100,000 copies/mL)2
The present analysis evaluated virological response rates for LPV/r QD and BID and DRV/r QD in treatment-naive patients in the ARTEMIS triaL3
1. Gathe J, et al. 11th CROI 2004. Abstract 570
2. Mildvan D, et al. 14th CROI 2007. Abstract 138
3. DeJesus E, et al. 47th ICAAC 2007. Abstract H-718b
Objective of exploratory analysis
Compare the efficacy and safety of DRV/r QD with LPV/r QD and BID
LPV/r dosing schedules were
--not randomised
--based on local regulatory approval* and investigator or patient preference
*LPV/r QD is approved for treatment-naive patients in the USA
Use of QD and BID dosing
in ARTEMIS
15% on LPV/R took QD and 77% took bid, 8% (n=27) who switched from bid to qd were excluded from the analysis.
conclusions
At Week 48, 84% of DRV/r patients versus 78% of LPV/r patients achieved a viral load <50 copies/mL
--DRV/r 800/100mg QD was non-inferior to LPV/r (QD or BID) in treatment-naive patients in the ARTEMIS primary efficacy analysis
DRV/r QD was superior to LPV/r (overall) in patients with baseline viral load ≥100,000 copies/mL
In this non-randomised comparison of ARTEMIS, patients receiving DRV/r QD compared with those receiving LPV/r QD demonstrated significant differences in
--virological response (<50 copies/mL) in patients with high viral load
--incidence of treatment-related, moderate to severe diarrhoea
--incidence of treatment-emergent, moderate to severe triglyceride elevations
Once-daily DRV/r is safe and effective in treatment-naive patients
Studies evaluating once-daily DRV/r 800/100mg in
treatment-experienced patients are ongoing
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