This study evaluates the ability of digital medicines, Proteus Discover, to promote adherence and thus achieving a cure for hepatitis C in patients at high risk for not adhering to their hepatitis therapy. In this single-arm, prospective study, subjects at high risk for nonadherence will be prescribed hepatitis C therapy that will be co-encapsulated with ingestible sensors (creating the digital medicine) by a pharmacy. Both the subject and the providers will have access to the ingestion adherence.
Hepatitis C virus (HCV) is a preventable and curable blood-borne virus. Adherence to HCV therapies is essential to achieve sustained virologic response (SVR) or cure. New direct-acting agents (DAA) are now available, such as fixed-dose combination of ledipasvir and sofosbuvir, which is given once daily with or without ribavirin to treat HCV infection in 8-12 weeks, which can cure hepatitis C with a once daily regimen. which is given once daily with or without ribavirin to treat HCV infection in 8-12 weeks. Providers and third-party payers are concerned that patients use these high-cost therapies as prescribed and obtain the intended value of their treatment, so as to prevent otherwise avoidable medicine wastage and re-treatment. Some HCV-infected patients are currently excluded from using the newer direct-acting therapies because they are considered to have a high risk of not completing their intended treatment, or they do not have access to care due to other issues like transportation difficulties. Additionally, third party payers and providers have proposed to assess patient adherence during treatment with HCV RNA level and additional adherence assessments. However, determining adherence to anti-viral therapy based upon decreases that are observed in RNA titers at intermittent intervals, or periodic assessments of medication use, subsequent to therapy initiation are indirect and retrospective. Additionally, this practice can be a burden for patients, especially those who live far away from their providers. Proteus Discover™ provides wirelessly observed therapy (WOT) for passive direct, timely confirmation of medication ingestion. Proteus Discover includes a FDA cleared and CE-marked device, which consists of three components: 1) an Ingestible Sensor (IS) embedded inside of a placebo pill, which can be co-encapsulated with prescribed medication (CEM); 2) a wearable sensor patch (herein referred to as the Proteus Patch), which passively detects and stores time-stamped CEM ingestions, as well as physiological and behavioral metrics such as heart rate and activity patterns (e.g., step count, time spent in physical activity, number of hours of rest); and 3) software to aggregate and display Proteus Patch data. The offering also includes the Proteus Discover App, which allows the subject to review and interact with the data via a mobile device. Providers can view the data via the Proteus Discover Portal. To provide WOT in this study, the Proteus Ingestible Sensor pill will be placed in a capsule along with HCV medication by the patient's pharmacy to create a digital medicine version of the therapy. The adhesive wearable sensor patch worn by the patient on the left lower torso will be used for detection of CEM ingestions which are then displayed on a mobile application for the patient, and on a web portal for physicians and the study healthcare teams to assist them in identifying when support for the subject may be needed for taking medication consistently.
The subjects in the study will be monitored using the Proteus Discover offering. Subjects will use Proteus Discover plus a digital version of HCV therapy (IS co-encapsulated with fixed-dose velpatasvir and sofosbuvir; fixed-dose ledipasvir and sofosbuvir; or fixed-dose glecaprevir and pibrentasvir; or fixed-dose sofosbuvir, velpatasvir, and voxilaprevir). The subject's prescribed HCV medication will be co-encapsulated with the Proteus Ingestible Sensor pill by an appropriately licensed and qualified pharmacy as per a licensed health care provider's order (prescription).
University of Alabama
Birmingham, Alabama, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
SVR12 Rate
Proportion of subjects achieving sustained viral response, 12 weeks following completion of their hepatitis C therapy
Time frame: 12 weeks following completion of their hepatitis C therapy
SVR4 Rate
Proportion of subjects achieving sustained viral response, 4 weeks following completion of their hepatitis C therapy
Time frame: 4 weeks following completion of their hepatitis C therapy
Ingestion Adherence
Mean ingestion adherence to the primary hepatitis C therapy measured by the digital medicine offering
Time frame: 8 to 16 weeks (during therapy)
Safety Profile:Summary details of all adverse events during the study
Summary details of all adverse events during the study
Time frame: Up to 24 weeks
Subject Satisfaction
Feedback from subjects during the study via a survey form
Time frame: 4 weeks following completion of their hepatitis C therapy
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Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
253
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Denver Health
Denver, Colorado, United States
Providence Health System
Washington D.C., District of Columbia, United States
Orlando Immunology Center
Orlando, Florida, United States
Apex Clinical Research
Tampa, Florida, United States
The Ruth M. Rothstein CORE Center
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
The Research Institute
Springfield, Massachusetts, United States
...and 6 more locations