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Effects of once-daily darunavir/ritonavir versus lopinavir/ritonavir on lipid parameters and anthropometrics in treatment-naïve, HIV-1-infected ARTEMIS patients at Week 96
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Reported by Jules Levin
IAS Capetown July 19-22 2009
Ezio Baraldi,1 Javier Morales-Ramirez,2 Stefan Schneider,3 Albrecht Stoehr,4 Anna Orani,5 Carline Vanden Abeele,6 Ludo Lavreys6
1Embassy Drive Medical Centre, Pretoria, South Africa; 2Clinical Research Puerto Rico, San Juan, Puerto Rico; 3Living Hope Clinical Foundation, Long Beach, CA, USA;
4Institute for Interdisciplinary Medicine, Hamburg, Germany; 5Division of Infectious Diseases, General Hospital, Lecco, Italy; 6Tibotec BVBA, Mechelen, Belgium
In ARTEMIS patients received tenofovir + FTC as background, not like in earlier days when d4T & AZT were widely used.
AUTHOR CONCLUSIONS
Lipid-associated AEs were reported in fewer DRV/r than LPV/r patients over
96 weeks.
There were relatively few lipodystrophy and anthropometric-associated AEs
reported in either arm over 96 weeks. (from Jules: in Table 2, there were 6 lipodystrophy associated AEs (1.7%) in DRV/r arm and 10 (2.9%) in LPV/r arm.
Over 96 weeks, fewer DRV/r than LPV/r patients had grade 2-4 treatment-emergent abnormalities of triglycerides and total cholesterol; these differences
were also seen in patients who were not receiving lipid-lowering agents. (from Jules: in patients not receiving lipid-lowering agents (table 3) 13.7% receiving DRV/r an 24.4% receiving LPV/r had grade 2-4 total cholesterol). LDL >130: 31.7% for DRV/r, 32.2% LPV/r).
The median percentage increase in triglycerides and total cholesterol from
baseline to Week 96 was greater for LPV/r compared with DRV/r; median
levels of triglycerides remained within NCEP cut-offs in the DRV/r group, but
not in the LPV/r group, where levels exceeded cut-offs as early as Week 2.
LDL increases were small and similar in the DRV/r and LPV/r groups and
remained below NCEP cut-offs.
At Week 96, median mid-waist/hip ratio was comparable to baseline in both
treatment groups
- no clinically relevant changes were seen with other anthropometric
measurements.
Safety and tolerability results from Week 48 were corroborated at Week 96,
and confirm that once-daily DRV/r 800/100mg is well tolerated and has a
more favourable lipid profile than LPV/r in treatment-naïve, HIV-infected
patients.
*The number of patients with data can vary per parameter, but the % reflects the true percentage of observed abnormalities; Worst grade, based on the Division of AIDS table for grading the severity of adult and paediatric AEs 2004, which does not have a grade 1 classification for triglycerides and grade 4 for total cholesterol and LDL; LDL calculated by the method of Friedewald et al7 (LDLc = total cholesterol - HDL - triglycerides/5). LDL was not calculated where triglycerides >400mg/dL (>4.52mmol/L); Below normal: <40mg/dL (<1.03mmol/L); NS = not significant; NA = not assessed; All
*The number of patients with data can vary per parameter, but the % reflects the true percentage of observed abnormalities. LDL calculated by the method of Friedewald et al7 (LDLc = total cholesterol - HDL - triglycerides/5). LDL was not calculated where triglycerides >400mg/dL (>4.52mmol/L)
REFERENCES
1. Ortiz R, et al. AIDS 2008;22:1389-97.
2. PREZISTATM (darunavir) Prescribing Information. Tibotec Inc. Revised June 2009 [accessed 03 July 2009]. Available from:
http://www.prezista.com/prezista/documents/us_package_insert.pdf.
3. PREZISTATM (darunavir). EPARs for authorised medicinal products for human use, 12 February 2009 [accessed 12 May 2009]. Available from:
http://www.emea.europa.eu/humandocs/Humans/EPAR/prezista/prezista.htm.
4. Mills AM et al. AIDS 2009. In press.
5. Hill A, et al. HIV Clin Trials 2009;10:1-12.
6. Arathoon E, et al. 17th International AIDS conference, Mexico City, Mexico, 3-8 August 2008. Poster THPE0151.
7. Friedewald WT, et al. Clin Chem 1972;18:499-502.
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