New Cholesterol Drug Shows Superiority to Pravastatin in HIV Patients

Kowa Pharmaceuticals America recently announced that pitavastatin (Livalo) 4-mg was superior to pravastatin 40-mg in reducing LDL cholesterol levels in patients with HIV and dyslipidemia. Additionally, the authors discovered that pitavastatin had a similar safety profile to pravastatin.

This patient population is notoriously difficult to treat due to concerns over drug interaction, according to a press release. The results from the phase 4 INTREPID clinical trial were published in The Lancet HIV.

"Dyslipidemia affects more than three-fourths of people with HIV, putting them at significantly increased risk for cardiovascular disease. However, treatment of elevated LDL cholesterol in this patient population is challenging because of drug interactions between statins and commonly used antiretroviral agents," said co-author Douglas Ward, MD. "The finding that Livalo was more effective than pravastatin in lowering LDL cholesterol and was well tolerated in HIV patients with dyslipidemia suggests it could be a viable treatment option for managing dyslipidemia and contributing factors in adults with HIV."

Included in the study were 252 patients with HIV (CD4 cell counts >200 cells/mm3 and HIV-1 RNA <200 copies/mL) and dyslipidemia (LDL-C between 130-220 mg/dL, triglycerides ≤400 mg/dL), according to the release. Patients were randomized to receive pitavastatin 4-mg or pravastatin 40-mg with matching placebo for 12 weeks.

The primary endpoint was percent change in fasting LDL levels from baseline through week 12, according to the release.

The authors discovered that patients treated with pitavastatin achieved a significant and superior reduction in LDL cholesterol compared with patients treated with pravastatin, a 31.1% reduction versus a 20.9% reduction, respectively. These differences were sustained through 52 weeks.

Levels of non-HDL cholesterol and apo B were also greater among those taking pitavastatin. The authors observed a 26.9% reduction of non-HDL cholesterol among pitavastatin-treated patients, while there was only an 18.7% reduction among pravastatin-treated patients after 12 weeks, according to the study. Apo b dropped 26.1% among patients treated with pitavastatin, but was only reduced 16.5% among those treated with pravastatin.

The authors reported no significant changes in glucose metabolism and insulin resistance in all patient groups.

Importantly, there were no significant treatment differences in HIV-1 RNA, CD4 cell counts, or virologic failure, which suggests that the newer drug may be safe to use in conjunction with antiretroviral therapy.

"The INTREPID trial is the first to evaluate the efficacy and safety of Livalo in this difficult-to-treat patient population. The results not only demonstrate that Livalo is superior to pravastatin in lowering LDL cholesterol, but also in maintaining moderate-intensity LDL cholesterol reduction similar to the non-HIV infected adult population," said Craig Sponseller, MD, chief medical officer, Medical Affairs, of Kowa Pharmaceuticals America, Inc. "Furthermore, Livalo can be used in patients receiving complex antiretroviral therapy at the highest dose of Livalo because it is not mainly metabolized via the cytochrome P450 enzyme system. This study, along with the landmark REPRIEVE trial to evaluate the effect of Livalo on primary prevention of cardiovascular disease in adults with HIV, underscores our commitment to providing a safe and effective treatment option for clinically complex patient populations, such as the elderly, patients with diabetes or patients who take multiple medications for co-morbid conditions.”