1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP
October 25 - 29, 2003 Warsaw, Poland
|
9TH EUROPEAN AIDS CONFERENCE (EACS) 1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP October 25 - 29, 2003 Warsaw, Poland |
| 9.1 Incidence/prevalence of Adverse Events in Different Settings F8/2 - PREVALENCE OF LIPODYSTROPHY AND RETINOID SYNDROME IN A 48-WEEK RANDOMISED TRIAL TO EVALUATE SAFETY AND EFFICACY OF INDINAVIR/RITONAVIR 800/100 MG VERSUS SAQUINAVIR/RITONAVIR 1000/100 MG: THE MAXCMIN1 TRIAL |
| (1) Saint-Pierre University Hospital, Brussels, Belgium,2 Copenhagen HIV programme, Hvidovre, Denmark,3 National Centre in HIV Epidemiology and Clinical Research, Darlinghurst, Australia,4 Ospedale San Raffaele, Milan, Italy,5 Ullevaal Hospital, Oslo, Norway,6 Royal Free Hospital, London, UK,7 Kantonsspital, St. Gallen, Switzerland,8 Helios Salud, Buenos Aires, Argentina,9 FUNDAI - F.J. Muniz, Buenos Aires, Argentina |
Background: Ritonavir®-boosted PI treatments may influence differently on development of lipodystrophy. Indinavir (IDV) treatment theoretically could result in retinoid syndrome events (RSE).
Methods: Assessment of the prevalence and severity of lipodystrophy (LD) and RSE after 48 weeks of IDV/r 800/100 mg bid or saquinavir/r (SAQ/r) 1000/100 mg bid combined with >/=2NRTI(s)/NNRTI(s)). The LD Case Definition study questionnaires for patients and physicians were used at week 48, and the same type of questionnaires evaluated RSE. Analyses are ITT/exposed.
Results: At week 48 LD was found in 38/242 patients (16%; 16% (IDV/r) vs. 15% (SAQ/r), p=0.85). In multivariate analyses, female gender (OR: 0.23, CI 95% 0.10-0.53, p=0.001) and mean duration of HIV infection (OR: 1.1 per year higher, CI 95% 1.04- -1.22, p=0.004) were correlated with LD. There was no correlation with age, BMI, risk group, baseline viral load or CD4 count, trough concentration of study PIs and lipid levels at week 4 and 48. LD and fat accumulation severity scores were significantly higher in females (p<0.001 for both), with no difference in lipoatrophy severity score (p=0.79). RSE were found in 98/242 patients (41%; 61% (IDV/r) vs. 19% (SAQ/r), p<0.0001). In the multivariate analysis, treatment group was predictive of RSE at week 48 (OR: 7, CI 95% 4-12, p<0.0001).
Conclusion: The prevalence of lipodystrophy at week 48 was similar in the IDV/r and SAQ/r arms, and was higher in females and patients with longer duration of HIV infection. Retinoid syndrome events were significantly more frequent in the IDV/r arm compared to the
Presenting Author: MD Stephane De Wit, Saint-Pierre University Hospital, Rue Haute,322, 1000, Brussels, Belgium, Phone: 00 32 2 535 41 30
031025
40
