Evaluation of Wirelessly Observed Therapy to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence to Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Proteus Digital Health, Inc.
- Enrollment
- 253
- Locations
- 16
- Primary Endpoint
- SVR12 Rate
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A subject must meet ALL of the following criteria to be considered for enrollment into this study:
- •Adults (≥18 years old) who are diagnosed with hepatitis C deemed chronic by the investigator
- •Candidate for treatment for oral direct acting agent for hepatitis C such as fixed-dose velpatasvir and sofosbuvir; fixed-dose ledipasvir and sofosbuvir; or fixed-dose glecaprevir and pibrentasvir with insurance coverage for therapy. Subjects may take other medicines that will not be co-encapsulated (e.g. ribavirin)
- •One of more of the following risk factors for nonadherence:
- •Active alcohol or substance abuse (positive urine drug screen, illicit use in past 3 months, and/or in opioid substitution program), OR
- •Patient reported history of hospitalization within past 2 years for a psychiatric comorbidity, OR
- •Evidence of nonadherence to medications (e.g. self-report or refill history indicative of nonadherence), OR
- •History of at least one missed clinic visit for hepatitis management, OR
- •Patient-reported history of one or more transportation barriers (e.g. burden due to time and/or distance or lack of access to regular transportation) to healthcare access, which creates a risk for missed or delayed care
- •Study subject has daily access to a telephone for communicating with the study personnel and study personnel contacting the study subject
Exclusion Criteria
- •ANY 1 of the following will exclude a subject from being enrolled into the study:
- •BMI \> 40 kg/m2
- •Active skin infection or active dermatitis, OR history of chronic inflammatory skin condition including psoriasis and chronic dermatitis (except atopic dermatitis)
- •Allergy to adhesive bandages/tapes (e.g. Band-Aids®)
- •Severely decompensated cirrhosis (Child-Pugh C) or a liver transplant candidate
- •Any condition that in the investigator's opinion could preclude safe participation in the study (e.g. contraindication to hepatitis C therapy) or would preclude the subject from being able to participate in the study protocol requirements
- •Participating in a drug study or medical device clinical study (including its safety follow-up period as defined by protocol) 30 days prior to study start or completion
- •Unwilling to take a gelatin capsule because it is manufactured from animal origins (e.g. for religious reasons)
- •Allergy to food dye
- •Terminal illness (≤ 1 year of life anticipated).
Outcomes
Primary Outcomes
SVR12 Rate
Time Frame: 12 weeks following completion of their hepatitis C therapy
Proportion of subjects achieving sustained viral response, 12 weeks following completion of their hepatitis C therapy
Secondary Outcomes
- Ingestion Adherence(8 to 16 weeks (during therapy))
- Safety Profile:Summary details of all adverse events during the study(Up to 24 weeks)
- Subject Satisfaction(4 weeks following completion of their hepatitis C therapy)
- SVR4 Rate(4 weeks following completion of their hepatitis C therapy)