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Landmark trial to explore the prevention of heart disease in people living with HIV

Trial will evaluate if a daily dose of the statin, pitavastatin, can reduce the elevated risk of cardiovascular disease in this patient population

FOR IMMEDIATE RELEASE

>MONTGOMERY, AL, October 28, 2014 – The National Institutes of Health (NIH)/National Heart, Lung and Blood Institute (NHLBI) are initiating a landmark multimillion dollar outcomes trial utilizing pitavastatin for the primary prevention of cardiovascular disease (CVD) in persons infected with HIV. The REPRIEVE (Randomized Study to Prevent Vascular Events in HIV) study will investigate whether a daily dose of pitavastatin will reduce the risk of CVD in people living with HIV. Kowa Pharmaceuticals America, Inc. will provide support by donating the study drug and additional study funds. The nationwide study is sponsored by the National Heart, Lung and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), with additional resources and collaboration from the National Institute of Allergy and Infectious Diseases (NIAID) and the AIDS Clinical Trials Group (ACTG) Network.

The randomized, double-blind clinical trial will span six years and include 6,500 participants from approximately 100 trial sites in North America. Steven Grinspoon, M.D., Director of the MGH Program in Nutritional Metabolism and Professor of Medicine at Harvard Medical School, will lead the REPRIEVE trial, with Co-Principal Investigators Pamela Douglas, M.D., Professor of Medicine at Duke University School of Medicine, Udo Hoffmann, M.D., M.P.H, Professor of Radiology at Harvard Medical School and Heather Ribaudo, Ph.D., Senior Biostatistician at Harvard School of Public Health. Additional study leadership includes Turner Overton, M.D., University of Alabama (Co-Chair), Carl Fichtenbaum, M.D., University of Cincinnati (Vice Chair), Judy Aberg, M.D., Mt. Sinai School of Medicine (Vice Chair), Markella Zanni, M.D., Massachusetts General Hospital (Vice Chair).

Study participants – HIV-infected men and women, ages 40-75, who are being treated for their infection and who have no known cardiovascular disease and low traditional risk factors for cardiovascular disease – will be randomized to receive either a 4 mg daily dose of pitavastatin or a placebo pill for up to 72 months. Within the larger group of 6,500 participants, 800 will also receive detailed assessments of the impact of pitavastatin treatment on the characteristics of arterial plaques and on biomarkers of inflammation in order to identify the mechanisms behind the effects of statin therapy in the primary prevention of CVD in this randomized, double-blind study.

An estimated 34 million people globally and 1.7 million Americans live with HIV, and recent data suggest that HIV-infected people have a 50- to 100-percent greater likelihood of developing cardiovascular disease compared with the general population. Importantly, there are no current treatment options that have been able to successfully demonstrate prevention of CVD in this population.

“The risks of heart attack and stroke in HIV-infected individuals are significantly higher than they are in uninfected people, and while some of these patients have traditional cardiovascular risk factors, recent studies suggest that HIV infection itself confers a unique set of risks, including immune system activation and arterial inflammation. Those findings contributed to the hypothesis that statin therapy – which reduces inflammation and immune activation, as well as lipid levels – may be particularly well tailored to reducing that cardiovascular risk,” says Dr. Grinspoon. “REPRIEVE will be among the largest randomized clinical trials conducted in the HIV population and the first study designed to investigate a large-scale cardiovascular disease prevention strategy in this population. By addressing the critical question of statin efficacy in this group of patients, the study should provide important information as to efficacy and safety of this strategy for primary cardiovascular disease prevention in this population.”

”We are very excited that pitavastatin was selected for this NIH/NHLBI sponsored landmark outcomes trial in a growing population at considerable risk for cardiovascular disease," said Craig Sponseller, M.D., Vice President of Medical Affairs at Kowa Pharmaceuticals America, Inc. “We are pleased to be able to support this important trial which we hope will lead to the first successful prevention strategy for cardiovascular disease in HIV-infected patients.”

The study is being funded through NHLBI grants U01HL123336 (clinical coordinating center) and U01HL123339 (data coordinating center). The AIDS Clinical Trials Group is funded through NIAID grants UM1 AI068636, UM1 AI106701, and UM1 AI068634.

About Kowa Company, Ltd. and Kowa Pharmaceuticals America, Inc.

Kowa Company, Ltd. (Kowa) is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various manufacturing and trading activities in the fields of pharmaceuticals, life science, information technology, textiles, machinery and various consumer products. Kowa's pharmaceutical division is focused on research and development for cardiovascular therapeutics (dyslipidemia, type 2 diabetes and atherosclerosis), ophthalmology and anti-inflammatory agents.

Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, AL, is focused primarily in the area of cardiometabolic diseases. Established in September 2008, Kowa Pharmaceuticals America focuses its efforts on the successful commercialization of its current and near-term portfolio of pharmaceutical products, and business development activities.

For more information about Kowa Pharmaceuticals America, visit www.kowapharma.com.

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