A Randomized Trial of the Efficacy and Safety of Fenofibrate versus Pravastatin in HIV-Infected Subjects with Lipid Abnormalities: AIDS Clinical Trials Group Study 5087

Abstract

There is a paucity of information on the safety and efficacy of lipid-lowering therapy for dyslipidemia associated with human immunodeficiency virus (HIV) and antiretroviral therapy. Our objective was to determine whether fenofibrate and pravastatin were equivalent for the treatment of combined dyslipidemia in HIV as measured by a composite of the National Cholesterol Education Project (NCEP) goals based on absolute values for low-density lipoprotein (LDL), triglycerides (TG), and high-density lipoprotein (HDL) and to compare the safety of these agents through 48 weeks. This was a randomized, open-label trial with subjects assigned to fenofibrate 200 mg (n = 88) or pravastatin 40 mg (n = 86) daily. Subjects who failed to reach the NCEP composite goal on monotherapy by week 12 received both drugs. The composite goal at week 12 was achieved in 1% of fenofibrate and 5% of pravastatin subjects. At week 16, 69/88 subjects on fenofibrate added pravastatin (FP) and 67/86 subjects on pravastatin added fenofibrate (PF). At week 48, 7% FP subjects and 3% PF subjects achieved the composite goal. Median changes in LDL/HDL/TG/non-HDL were -8/+5/-144/+50 and -14/+2/-66/+34 mg/dl in subjects receiving FP and PF, respectively. There were few adverse events and no rhabdomyolysis reported. Combination therapy with fenofibrate and pravastatin for HIV-related dyslipidemia provides substantial improvements in lipid parameters and appears safe, but is unlikely to achieve all NCEP targets for lipid levels.

An Update on Heart Transplantation in Human Immunodeficiency Virus–Infected Patients

“…Furthermore, absence of active AIDS-defining opportunistic infection (OI) or malignancy is mandatory (32,33); however, patients with OIs that can be treated efficaciously or prevented, such as Pneumocystis jirovecii pneumonia (PCP), can be included on the HT waiting list (32,33). In the present report, only one of the HIV-infected patients who underwent HT in the cART era had a history of OIs (PCP, disseminated Mycobacterium avium complex and cytomegalovirus infection) (14,29). This patient was one of the two who died after HT ( Table 2).…”

“…Published experience with HT in the setting of HIV infection is scant. The present review includes data from small retrospective cohort studies, case series, and cases published in indexed journals (2)(3)(4)(5)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30). The data presented comprise reports of patients who acquired HIV infection before, during and after HT.…”

“…One of the two remaining patients had suboptimal adherence to treatment and died of multiorgan failure (24). The cause of death in the other patient was not reported (29). The mortality rate of patients undergoing HT in the cART era was much lower than that of patients who underwent HT in the pre-cART era (2 of 15 [13%] vs. 6 of 11 [55%], respectively).…”

Association of non-HDL cholesterol with subclinical atherosclerosis in HIV-positive patients

“…A particularity of dyslipidemia in HIV+ patients treated by c-ART is the combination of lipid disturbances related firstly to the HIV infection per se and secondly induced by c-ART. Management of this complex dyslipidemia appears as an important challenge for clinicians, as often, lipid lowering therapy alone does not allow to reach the lipid target 36,41,42 and should be associated to diet and lifestyle modification and/or switching of some antiretroviral agents 43 . A specific disturbance that persists in about half of patients is a trend to low HDL-C levels and moderate hypertriglyceridemia.…”

HIV infection, aging and cardiovascular disease: epidemiology and prevention

“…93 Even when lipid-lowering drugs are used, more than 50% do not reach the levels recommended by the ATP-III guidelines in two cohort studies 94,95 and one randomised trial. 96 The management of hypertension and diet are components of the management and prevention of dyslipidaemia and CVD. 90,92 In the general population, dietary interventions are effective in reducing hypertension.…”