12th Conference on Retroviruses and Opportunistic Infections Boston, Massachusetts - February 22-25, 2005

Conf Retrovir Opportunistic Infect 2005 Feb 22-25;12:abstract no. 39

Pierre De Truchis¹, M Kirstetter², A Perier³, C Meunier⁴, J Gardette⁴, J C Melchior⁵, and Maxepa-VIH Study Group
¹Hosp R Poincare, Univ Paris-IFO,Garches, France; ²Private Practice, Paris, France; ³Cardinal System, Paris, France; ⁴Lab Pierre Fabre Santé, Castres, France; and ⁵Hosp R Poincare, Univ Paris-IFO,Garches, France

BACKGROUND: Blood lipid changes, particularly hypertriglyceridemia, are frequently observed in HIV-infected patients receiving ART. The increasing incidence of such dyslipidemia is probably associated with high cardiovascular risk. Omega-3 polyunsaturated fatty acids are able to decrease serum triglycerides, and may be useful in this population.

METHODS: A prospective double-blind randomized trial with Maxepa® (M) (2 capsules 3 times a day; 1-g fish oil capsules containing 18%EPA-12%DHA) vs placebo (P) (1-g paraffine oil capsules) was conducted in 122 HIV-infected patients (60 on M, 62 on P) under multitherapy, with hypertriglycerides > 2 g/L after 4 weeks of appropriate diet (mean baseline triglycerides = 4.5 ± 1.9 g/L). Patients received 8 weeks of M or P, then 8 more weeks of M in an open-label phase. Evaluation criteria were median percentage triglyceride change at week 8, percentage of responders (> 20% triglycerides decrease), and tolerance issues. Patients with baseline triglycerides > 10 g/L were not randomized and received open M.

RESULTS: In an intent-to-treat analysis, median change of triglycerides was –25.5% in group M, vs +1% in group P at week 8 (p = 0.0033). At 8 weeks, mean triglycerides was 3.4 ± 1.8 g/L in group M, and 4.8 ± 3.1 g/L in group P; triglycerides were normalized in 22.4% (M) vs 6.5% (P) (p = 0.012); percentage of responders was 58.6% (M) vs 33.9% (P) (p < 0.007). During the open period, the decrease of triglycerides was sustained in M patients (mean triglycerides = 3.4 ± 1.7 g/L at week 16), while a triglyceride decrease of 21.2% was observed in P patients (mean triglycerides = 3.3 ± 1.4 g/L at week 16). Safety was good; no statistically significant differences were observed for occurrence of adverse events between M and P. The mean decrease of triglycerides in open-treated patients with baseline elevated triglycerides (n = 10) was –35.6% (median triglycerides from13.3 g/L at baseline, to 7.1 g/L at week 8). No significant change over time was observed for total- and HDL-cholesterol.

CONCLUSIONS: This study demonstrates the efficacy of Maxepa® to decrease triglycerides in ART-treated HIV-infected patients with baseline elevated triglycerides; it could represent a potential option for first line therapy for ART-associated hypertriglyceridemia because of its efficacy, good tolerance, and absence of drug interactions.

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