Digital Medicine System has the potential to provide clinicians with a new tool to track and manage adherence for HIV prevention therapy
GAINESVILLE, Fla. (March 4, 2019) – etectRx™, a privately held digital health company, is pleased to announce that its ID-Cap™ System, featuring state-of-the-art ingestion event monitoring technology, has been selected for a new study to observe adherence for the HIV prevention drug TRUVADA (tenofovir/emtricitabine) for PrEP® (Pre-Exposure Prophylaxis).
The study will be conducted at Brigham and Women’s Hospital in Boston and in partnership with The Fenway Institute at Fenway Health, one of the preeminent LGBT health and HIV research organizations in the world. The manufacturer of TRUVADA for PrEP, Gilead Sciences, is funding the study, led by principal investigator, Dr. Peter Chai, M.D., M.M.S., toxicologist in the Department of Emergency Medicine at Brigham and Women’s Hospital; and Assistant Professor, Harvard Medical School. The purpose of the study is to examine medication adherence patterns and understand how adherence can be increased among populations at risk for HIV infection.
“Improved medication adherence is an essential strategy for ending the spread of HIV,” said Kenneth H. Mayer, M.D., medical director and co-chair of The Fenway Institute at Fenway Health. “We are enthusiastically supporting Dr. Chai’s research in this area and looking forward to seeing the results.”
etectRx’s ID-Cap System is an ingestible event marker that utilizes proprietary, in vivo communications technology between an ingestible sensor and an external, wearable reader. The system is comprised of the ID-Capsule, ID-Tag, ID-Cap Reader and related software which allows data to be displayed for the patient and clinician. The ID-Capsule is a standard pharmaceutical capsule shell containing the ID-Tag, an ingestible sensor that emits a very low power radio frequency (RF) digital message from within the patient to the ID-Cap Reader, a wearable device which verifies the message as a valid ingestion event and forwards the data using Bluetooth technology to secure data display systems utilized by clinicians and patients.
TRUVADA for PrEP is a prescription medicine that can help reduce the risk of contracting HIV-1 through sex, when taken every day for people who are currently HIV-negative and at risk of contracting HIV-1. In clinical studies, TRUVADA for PrEP has been shown to decrease the chance of HIV infection by close to 100 percent when users are adherent and is recommended by the Centers for Disease Control and Prevention when taken every day as one part of a complete HIV prevention plan. The effectiveness of TRUVADA for PrEP in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.*
The participants in the study currently receive care at Fenway Health and will use the ID-Cap System for 90 days.
“We are honored that these world-class institutions have selected etectRx’s ID-Cap technology to aid in the study of this life-changing prevention therapy,” said Harry J. Travis, president and CEO of etectRx. “We look forward to assessing the impact that the ID-Cap System can have on the lives of people at risk of contracting HIV.”
etectRx submitted a premarket notification (510(k)) application with the U.S. Food and Drug Administration (FDA) for its ID-Cap System as an ingestible event marker in late 2018 and anticipates FDA clearance for marketing this year. The ID-Cap System is currently only available for investigational use in IRB-approved clinical studies.
*Gilead Sciences, Inc., 2019 https://www.truvada.com/truvada-safety/clinical-studies
etectRx is a privately held digital health company seeking to advance patient medication adherence and improve medication ingestion tracking technology. etectRx’s flagship product, the ID-Cap System, is an ingestible event marker that is comprised of a gelatin capsule containing a wireless ingestible sensor, which transmits signals to a wearable reader and then to a smartphone-based app and secure cloud-based server to enable reliable tracking of ingestion events. To learn more about etectRx, visit https://etectrx.com/.
About Brigham Health
Brigham Health, a founding member of Partners HealthCare, is a global leader in creating a healthier world. Brigham Health consists of Brigham and Women’s Hospital, Brigham and Women’s Faulkner Hospital, the Brigham and Women’s Physician Organization and many related facilities and programs. With more than 1,000 inpatient beds, approximately 60,000 inpatient stays and 1.7 million outpatient encounters annually, Brigham Health’s 1,200 physicians provide expert care in virtually every medical and surgical specialty to patients locally, regionally and around the world. An international leader in basic, clinical and translational research, Brigham Health has nearly 5,000 scientists, including physician-investigators, renowned biomedical researchers and faculty supported by over $700 million in funding. The Brigham’s medical preeminence dates back to 1832, and now, with 19,000 employees, that rich history is the foundation for its commitment to research, innovation and community. Boston-based Brigham and Women’s Hospital is a teaching affiliate of Harvard Medical School and dedicated to educating and training the next generation of health care professionals. For more information, resources, and to follow us on social media, please visit brighamandwomens.org.
About Partners HealthCare
Partners HealthCare is an integrated health system founded by Brigham and Women’s Hospital and Massachusetts General Hospital. In addition to its two academic medical centers, the Partners system includes community and specialty hospitals, community health centers, a physician network, a managed care organization, home health and long-term care services and other health-related entities. Partners is one of the nation’s leading biomedical research organizations and a principal teaching affiliate of Harvard Medical School. Partners HealthCare is a non-profit organization.
About The Fenway Institute at Fenway Health
The Fenway Institute is an interdisciplinary center for research, training, education, and policy development, focusing on national and international health issues. Our mission is to ensure access to quality, culturally competent medical and mental health care for traditionally underserved communities, including lesbian, gay, bisexual and transgender (LGBT) people and those affected by HIV/AIDS. We do this by conducting innovative research and developing education and advocacy programs grounded in the LGBT community.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
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