Study objectives: To evaluate the safety and efficacy of simvastatin for treatment of dyslipidemia in patients with the human immunodeficiency virus (HIV) who were receiving efavirenz-based highly active antiretroviral therapy (HAART), and to evaluate the effect of simvastatin when added to efavirenz on CD4(+) count, HIV viral load, and frequency of attainment of patient-specific National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III lipid goals.
Design: Retrospective medical record review.
Setting: Veterans Affairs health care system in Dallas, Texas.
Patients: Thirteen HIV-infected men who received a stable efavirenz-based HAART regimen concurrently with simvastatin 20 mg/day, and 19 HIV negative men who received simvastatin 20 mg/day (controls).
Measurements and main results: Demographic, clinical, and laboratory data were collected before and after starting simvastatin. Reductions in lipid profile values in the HIV-infected group versus HIV-negative group were as follows: total cholesterol -20% versus -28% (p=0.15), low-density lipoprotein cholesterol (LDL) -36% versus -41% (p=0.06), non-high-density lipoprotein cholesterol (non-HDL) -22% versus -33% (p=0.212), and total cholesterol:HDL ratio -33% versus -30% (p=0.26). These effects were seen without any documented adverse drug reactions or changes in viral and immunologic control. However, 28% fewer HIV-infected patients were able to achieve NCEP ATP III LDL goals compared with HIV-negative subjects.
Conclusion: These preliminary comparative data suggest that simvastatin can be safely and effectively used to treat dyslipidemia in HIV-infected patients receiving efavirenz-based HAART without compromising viral or immunologic control. However, our results are suggestive of slight lessening of the LDL-lowering effects, which might be explained by the known reduction in simvastatin levels with efavirenz. Furthermore, fewer HIV-infected patients were able to meet their NCEP ATP III goals compared with HIV-negative controls, highlighting the difficulty in treating this population to current standards of care.