There are approximately 3.4 million people living with AIDS in North and South America, 1.1 million of whom live in the US. An estimated 500,000 are on Highly Active Antiretroviral Therapy (HAART), FDA-approved drugs to treat HIV infection. In the dietary supplement realm, there is only one product formulated for people living with HIV and AIDS. Nutraplete Therapeutic Drink Mix is made by Aventura, FL-based Galea Life Sciences, Inc. According to the company, the product helps improve overall health and stamina by replacing needed nutrients diminished by chronic illness.
What's more, Nutraplete was recently approved for Medicaid Reimbursement in New York, New Jersey, Connecticut, Nevada, Illinois and Washington State, which together account for nearly 500,000 persons living with HIV/AIDS. Although the product is not classified as a drug, it is only available by prescription.
"Our strategy is to make Nutraplete available through Medicaid pharmacy programs in areas of this country where it is most needed, and as soon as possible," commented Paul Zuromski, chairman and president of Galea Life Science. "This effort is being facilitated with our exclusive distributor, Allion Healthcare's MOMS Pharmacy, helping to make Nutraplete available to people living with HIV/AIDS in these Medicaid-approved states."
Galea Life Science has also applied for Medicaid reimbursement approval in California, Texas, Florida, Pennsylvania, Maryland and Washington, D.C. Once these additional Medicaid jurisdictions become Nutraplete-ready, the company will be able to market, with partner Allion Healthcare, Inc., to approximately 910,000 potential Nutraplete consumers, or approximately 70% of people living with HIV/AIDS in the US. In addition, there are 15 states where Nutraplete can immediately be prescribed and reimbursed by Medicaid with prior approval.
When asked if Nutraplete might pave the way for other nutraceuticals and insurance approvals, Mr. Zuromski was unsure. "Each state has its own criteria for Medicaid approval, and a product has to stand on its own merits," he said.
After spending a number of years in development, Nutraplete was brought to market in 2008. Described by Galea Life Science as a "multi-nutritional, therapeutic 'functional food,'" the product includes pharmaceutical grade supplements that "may provide health benefits" by addressing common nutritional deficiencies and by helping to support body weight and energy. The powdered beverage mix contains a proprietary blend of 29 ingredients including protein, vitamins, antioxidants and enzymes, including two proprietary ingredient blends of Immunolin and Kre-Alkalyn, which the company said have been shown to facilitate maintenance and increase of muscle mass, improve and soothe digestion, and improve immune function.
Immunolin is a patented bioactive protein ingredient that provides "high-quality, lactose-free immunoglobulins, which neutralize viruses and harmful bacteria (while supporting friendly intestinal bacteria)." It also contains transferrin and other acute-phase proteins that help provide optimum immune system support.
Kre-Alkalyn a patented buffered creatine in a pharmaceutical delivery system providing maximum stability and absorption by not breaking down into creatinine, reaching muscle cells at full strength to "help increase lean body mass without renal issues associated with other creatine products."
The beverage also includes glutamine and components to maximize glutathione production, probiotics, ginger and colostrum-containing immunoglobulins.
The blend of ingredients is said to provide "easily absorbed protein and fats to counter metabolic demands," and includes bromelain, a general digestive enzyme, and acetyl L-carnitine.
The product's multiple antioxidants include glutathione-promoting components (glutathione must be synthesized intracellularly for maximum effect), alpha lipoic acid and vitamin C to recycle glutathione, and quercitin to recycle alpha lipoic acid, vitamin C and glutathione. It also contains selenium, an integral component of glutathione peroxidase, plus B vitamins and folate.
Nutraplete is currently available in two flavors: Lemon Lime (46.5 g per serving) and Green Grape (45.4 g per serving). The recommended dosage is three times per day. Each daily serving of Nutraplete provides 500 calories based on easily digested protein, vitamins, minerals, enzymes and antioxidants.
The product is based upon research showing that nutrient intake can improve antiretroviral absorption and tolerance, and that receiving appropriate nutrition can improve the health and quality of life of HIV-infected individuals.
Mr. Zuromski said clinical product evaluations are currently underway in Seattle, WA, and Miami, FL. He was also excited about the potential future uses of Nutraplete. "Nutraplete can be effective in other markets such as chemotherapy, the infirm/geriatric and gastric bypass," he said.