[LbPeB9018] A prospective, multicenter, randomized trial comparing the efficacy and safety of fenofibrate versus pravastatin in HIV-infected subjects with lipid abnormalities: ACTG 5087

14th International AIDS Conference

Barcelona, Spain — July 7-12, 2002

[TITLE:] A prospective, multicenter, randomized trial comparing the efficacy and safety of fenofibrate versus pravastatin in HIV-infected subjects with lipid abnormalities: ACTG 5087

[AUTHOR(S):] Judith Aberg¹, Robert Zackin, Scott Evans, Yijun Yang², Beverly Alston³, W.Keith Henry⁴, Marshall Glesby⁵, Susan Brobst⁶

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. LbPeB9018

[ABSTRACT:] Objective: To determine whether fenofibrate (F) and pravastain (P) are equivalent and the safety of these agents in the treatment of HIV-related dyslipidemia at week 12

METHODS: HIV-infected persons with dyslipidemia (LDL ≥ 130 mg/dL and TG ≥ 200 mg/dL) on ART for > 6 months were randomized to receive either P 40 mg or F 200 mg (F) daily. Subjects who had failed to reach the National Cholesterol Education Program (NCEP) goal (a composite of LDL, HDL, and TG levels, and pre-existing CV risk factors) by week 12 received both P and F and were followed for a total of 48 weeks. Enrollment was suspended prior to targeted accrual (630) after the initial review by a DSMB concluded that both arms met pre-determined criteria for futility of treatment.

RESULTS: 86 subjects were randomized to receive P and 88 to receive F. 170/174 subjects had available 12-week lipid data. At week 12, 4 subjects (5%) on P achieved the NCEP composite goal and 1 (1%) subject on F achieved goal. 30 (36%) of P recipients met LDL goals; 8 (9%) of F subjects met LDL goal (p < 0.001). 41 (49%) of subjects on P met HDL goals, whereas 57 (66%) of subjects on F met HDL goal (p < 0.05). 15 (18%) of subjects on P met TG goal, whereas 42 (48%) of subjects on F met TG goal (p < 0.001). Median changes in LDL/HDL/TG were -30/0/-27 and +13/+4/-118 mg/dL in subjects receiving P and F, respectively (p-values for treatment difference were all significant). 136 subjects subsequently went on dual therapy. Four subjects (3F, 1P) discontinued therapy due to protocol-defined toxicities in the first 12 weeks. There were no reports of rhabdomyolysis.

CONCLUSIONS: Monotherapy with either P or F for HIV-related dyslipidemia appears safe but unlikely to achieve composite NCEP goal. P appears to be most effective in lowering LDL, while subjects receiving F had larger increases in HDL and decreases in TG. Dual therapy with P and F is being evaluated for effectiveness at achieving composite NCEP goal.

Presenting author: Judith Aberg

1 Washington University, Saint Louis, United States

2 Not available

3 Not available

4 Not available

5 Not available

6 Not available

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