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Global packaging company has received a grant from The Bill & Melinda Gates Foundation to improve adherence and accuracy during PrEP trials
MeadWestvaco Corporation (NYSE: MWV), a global leader in packaging and packaging solutions, has received a grant to provide its Medication Event Monitoring System (MEMS™) to The Bill & Melinda Gates Foundation. The system is being used in the foundation’s new demonstration projects on pre-exposure prophylaxis (PrEP) medications to help prevent the spread of HIV/AIDS in sub-Saharan Africa and India. The four studies launched in October 2014.
Orally administered PrEP medications represent an important tool in the efforts to eradicate HIV/AIDS worldwide. These medications are given to high-risk but HIV-negative people, and have been shown to prevent transmission of the virus when people are adherent to their medication program[i]. MWV’s MEMS System measures, monitors and improves adherence. It has previously been used in pivotal studies for HIV medications including Gilead’s TRUVADA®, the first oral HIV medication the U.S. Food and Drug Administration approved for PrEP.
“PrEP medications are transforming the way we approach the global HIV/AIDS battle, offering a promise of protection against this deadly virus,” said Bernard Vrijens, PhD, chief science officer, MWV Healthcare. “However, this transformational intervention is only effective when people adhere to the prescribed dosing regimen. MWV Healthcare is grateful for the opportunity to join with the Gates Foundation in this important research, helping to understand and increase adherence to these life-changing medications.”
MWV Healthcare’s system utilizes its MEMSCap™ smart electronic medication packaging. The system tracks each time the medication bottle is opened, a proven corollary for measuring when a pill is taken. These data are wirelessly transferred to MWV Healthcare’s MedAmigo™ platform, a secure, web-based program for data analysis and modeling.
During the foundation’s trials, MWV’s scientific staff will analyze adherence data and provide trial coordinators with real-time feedback about each participant’s adherence. When provided to participants, this real-time feedback at the point of care has been shown to be the most effective adherence intervention available[ii]. In recent draft guidance, the FDA has recommended using smart medication packaging to measure and enhance adherence in clinical trials.[iii]
MWV Healthcare’s MEMS System is cited in nearly 700 peer-reviewed, published papers and has been used in nearly a thousand clinical trials, demonstrating the proven link between medication adherence and efficacy. MWV Healthcare provides both electronic and non-electronic adherence packaging in form factors including blisters, bottles and injectables to pharmaceutical companies worldwide, for use in both trials and clinical care. MWV’s solutions are proven and scalable, both when used alone and also as a foundation for broader adherence programs.
[i] Baeten, et al, N Engl J Med 367, 399-410, 2012
[ii] Demonceau et al. Drugs 73:545-562, 2013; Vrijens et al. Expert Review Clin Pharmacol 7(5):633-44, 2014
[iii] Guidance for industry: Enrichment strategies for clinical trials to support approval of human drugs and biological products. U.S. Food and Drug Administration. 2012 Dec. www.fda.gov. Accessed August 25, 2014.