SIMpill HCVEvaluation of the SIMpill Medication Dispensing Device in the Treatment of Chronic Hepatitis C

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.