Hepatitis C Clinical Trial
Official title:
A Phase 2 Clinical Trial of A Technology-Based Application To Improve The Triple Therapy Adherence Rate In Subjects With Chronic Genotype 1 Hepatitis C Infection
No more than 56% of subjects at the Robley Rex Louisville Veterans Administration Medical Center (VAMC) prescribed boceprevir-based triple therapy, will complete Hepatitis C (HCV) treatment as prescribed. Of patients who did not complete therapy, the primary reasons for discontinuation were side effects (48%) and non-adherence (32%). An intervention is needed to improve the treatment completion rate in subjects so they can achieve the high SVR rates noted in SPRINT-2 and RESPOND-2
This protocol is a Phase II Open Label Clinical Trial of a technology-based application "On-Plan" (OP) which is expected to improve adherence to boceprevir-based triple therapy in subjects with chronic genotype 1 hepatitis C infection compared to historical controls from the University of Louisville. OP uses a combination of smart phone and computer-based social support to correct non-adherence and manage side effects as well as contingency management (positive reinforcement) when patient-reported compliance is documented by pill counts and/or electronic compliance monitors. 52 consenting subjects prescribed boceprevir-based triple therapy for chronic genotype 1 HCV according the U.S. prescribing information will be enrolled and all will receive the OP application. A Simon's two stage procedure will be utilized to minimize risk while preliminary efficacy/safety data are collected on this innovative "app" for HCV therapy. ;
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