Hepatitis C, Chronic Clinical Trial
Official title:
Evaluation of Wirelessly Observed Therapy to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence to Treatment
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 Discoverâ„¢ 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.
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