SIMpill Medication Dispensing Device in the Treatment of HCV

Study Overview
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Brief Summary
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Subjects are being asked to participate in this study because they have genotype 1 Hepatitis C Virus (HCV) and will be taking the standard of care drugs pegylated interferon, ribavirin, and telaprevir as part of their routine care. The purpose of this study is to see if the SIMpill automated pill dispensing device can help subjects take their medications at the times the doctor has instructed them to take it. The SIMpill device is an automated pill dispensing device that records a time stamp each time the device is opened and a dose of medication is taken. Physicians can download this data and generate a precise account of when you have taken your medication. In addition, if a dose is missed, the SIMpill device can be set to automatically notify you by text message if a dose is overdue. The Simpill device is a new way to keep track of when you take your HCV medications and will also help remind you when you forget to take a dose. In addition, this information will help your doctors understand how taking medication on time effects the success of the therapy.

Detailed Description
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Patients with genotype 1 HCV who are candidates for therapy with telaprevir, pegylated interferon and ribavirin will be eligible for the study. All patients enrolled in this study will receive a standard of care regimen of telaprevir /pegylated interferon and ribavirin. This includes medication dosages, follow-up, and monitoring. The only exception will be the mode of medication dispensing. Patients will be asked to bring their Simpill devices to their regularly scheduled clinic visits at which time medication adherence information will be downloaded by study personnel. Each visit will be a regularly scheduled standard of care visit and no additional clinic visits will be needed for the patient in the Simpill study arm. In the event that any patient demonstrated viral breakthrough during therapy, those patients will be offered an additional blood draw to screen for viral resistance. This will be important to understand if patients using the Simpill device have better adherence to the medication regiment which results in lower incidence of viral resistance. Patients in the study arm will receive a text messages each time a dose of medication is missed. This message will only go to the telephone number specified by the patient and will not go to members of the study team. Patients who do not have text messaging capability will not be eligible for this study. The initial study will be a pilot study designed to obtain preliminary data regarding the feasibility of this device. This study is powered to detect differences in viral kinetics over the first 4 weeks. In the event that Vertex receives FDA approval for BID dosage of telaprevir prior to funding and initiation of the study, the most currently approved dosing (BID) will be used instead of q8 hours.

Official Title
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Evaluation of the SIMpill Medication Dispensing Device in the Treatment of Chronic Hepatitis C

Conditions
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Chronic Hepatitis C Virus

Intervention / Treatment
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* Device: SIMpill device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 18 - 70 with genotype 1 HCV Compensated liver disease who are independently deemed an appropriate candidate for telaprevir containing HCV treatment regimen Exclusion Criteria: Prior liver transplantation Co-infection with other types of viral hepatitis and HIV

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1<br>Subjects in this arm will receive their medication (telaprevir, interferon and ribavirin) dispensed using the Simpill device. The study staff will have access to data from the device during therapy and will be able to give subjects feedback on adherence during the course of therapy. The study team will refill the device as the medication is needed. The device will be configured to remind a subject each time a dose is missed. Subjects in this study arm will receive a text message each time a dose of medication is missed. This message will only go to the telephone number specified by the subject and will not go to members of the study team. | Device: SIMpill device<br>* The SIMpill device is an automated pill dispensing device that records a time stamp each time the device is opened and a dose of medication is taken. This works through a computer chip that is housed inside of the pill dispensing device that is activated each time the pill box is opened. Physicians can download this data and generate a precise account of the patient's adherence to the medication dosing schedule. In addition, if a dose is missed, the SIMpill device can be set to automatically notify the patient by text message if a dose is overdue.<br>|
| Arm 2<br>Subjects in this arm will receive their medication (telaprevir, interferon and ribavirin) as standard of care therapy where the SIMpill device will not be used. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved SVR Rates | To determine if the Simpill devise will improve viral kinetics from week 0 to week 4, leading to improved SVR rates. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Patient Adherence Rates | To determine overall adherence rates among patients taking telaprevir | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SIMpill, HCV, Chronic Hepatitis C Virus