PREZISTA® /r: Tolerability Proven Over Time
Median Lipid Levels Remained Below NCEP Cutoff Levels From Baseline Through 48 Weeks With Once-Daily PREZISTA®/r1, 2
Approximately 50% fewer laboratory abnormalities for triglycerides, total cholesterol, and LDL calculated cholesterol were reported with Once-Daily PREZISTA®/r vs twice-daily PREZISTA®/r1
The clinical relevance of this information is unknown.
* NCEP (National Cholesterol Education Program) cutoffs: triglycerides <150 mg/dL; LDL <130 mg/dL; total cholesterol <200 mg/dL; HDL >40 mg/dL.2
LDL=low-density lipoprotein; HDL=high-density lipoprotein; TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.
Selected laboratory abnormalities3, 4
This is not a complete list of all laboratory abnormalities.
*
ODIN: A randomized, open-label, Phase 3, 48-week, noninferiority clinical trial comparing Once-Daily PREZISTA®/ritonavir 800/100 mg with twice-daily PREZISTA®/ritonavir 600/100 mg in treatment-experienced adult patients with no DRV RAMs (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V).
†
ARTEMIS: A randomized, controlled, open-label, Phase 3, noninferiority clinical trial comparing PREZISTA®/r 800/100 mg once daily (n=343) with Kaletra® 800/200 mg per day (n=346) in treatment-naïve adult patients with HIV-1
RNA ≥5000 copies/mL.
‡
TITAN: A randomized, controlled, open-label, Phase 3 clinical trial comparing PREZISTA®/r 600/100 mg twice daily (n=298) with Kaletra 400/100 mg twice daily (n=297) in less treatment-experienced, lopinavir-naïve adults.
§
Based on the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Paediatric Adverse Events 2004, which does not have a grade 1 classification for triglycerides and grade 4 for total cholesterol and LDL.
Kaletra (lopinavir/ritonavir) is a registered trademark of AbbVie Inc.
