Overview | HCV-TARGET Home

		Unique Features	CDISC compliant database allowing the data to be shared directly with the FDA for analyses around safety and efficacy as part of a formal MOU (#225-13-0012) executed in 2013. HCV-TARGET developed standardized, centralized chart data abstraction methods along data monitoring to increase the efficiency and quality of an observational registry while also minimizing costs typically associated with performing post-marketing clinical research. HCV-TARGET hosts REDCap databases that are CFR 21 Part 11 compliant and includes MEDRA adverse event and WHO drug dictionary coding standardization.
		Aims	Primary aims: Safety and efficacy in populations represented and underrepresented in phase III clinical trials African Americans / Hispanics, cirrhosis, null responders, age > 65, transplant Subgroup analyses to determine the cumulative influence of IL28B, fibrosis, viral subtype (1a vs 1b), other co-morbidities Prior DAA containing regimen failures Refine/Define point estimates and narrow/define confidence intervals for SVR Adverse event surveillance and management Drug-drug interactions Virologic breakthrough and resistance Biorepository sample collection Impact of viral load measurement on treatment efficacy Evaluate/inform FDA pharmacometric modeling Unstudied populations and dosing regimens Long Term Health Outcomes (annually after SVR determination) Impact of SVR/lack of SVR on HCV co-morbidities Persistence of existing co-morbid conditions Development of new co-morbid conditions Patient centered outcomes research Under development and to be piloted at select sites in 2015 Secondary Aims: Safety and efficacy in special populations HIV/HCV co-infection, pre-liver transplantation (decompensated cirrhosis), post liver transplantation, renal failure, genotype 2 and 4 patients PEG-IFN 2a / 2b with different PIs + lead-in Frequency and impact of switching PIs Surveillance of drug-drug interactions Measurement of treatment adherence Impact of pretreatment education Impact of specialty pharmacy
		Phase 1	Longitudinal, observational study Inclusion criteria: All adult patients (older than age 18) being treated with antiviral regimens that contain telaprevir or boceprevir Ability to provide written informed consent for participation Exclusion criteria: Inability to provide written informed consent Biorepository: baseline DNA and serum at key timepoints Baseline, week 2, 4/8, 12/16, EOT (protocol or breakthrough/relapse), follow-up SVR (12 or 24) Primary aims: Safety and efficacy in populations represented and underrepresented in phase III clinical trials African Americans, Hispanics cirrhosis null responders age > 65 To refine point estimates and narrow confidence intervals for response to therapy Current data precludes meaningful subgroup analyses to determine the cumulative influence of IL28B, fibrosis, viral subtype (1a vs 1b), other co-morbidities Evaluate/inform FDA pharmacometric modeling Unstudied populations Boceprevir: Null responders indication Unstudied dosing Boceprevir: late responders duration of 32 weeks Telaprevir: shorter therapy for prior relapse with eRVR Virologic breakthrough and resistance Impact of viral load measurement on treatment efficacy Compliance and utility of current futility rules Clinical relevance of “detectable / BLOQ” vs “undetectable” Adverse event management and surveillance Prediction of drug-drug interactions and mapping of off-target safety effects Secondary Aims: Safety and efficacy in special populations HIV/HCV co-infection, pre-liver transplantation (decompensated cirrhosis), post liver transplantation, renal failure, genotype 2 and 4 patients PEG-IFN 2a / 2b with different PIs + lead-in Frequency and impact of switching PIs Surveillance of drug-drug interactions Measurement of treatment adherence Impact of pretreatment education Impact of specialty pharmacy
		Phase 2	Longitudinal, observational study Prospective and sequential Inclusion criteria: Adult patients (≥ 18 years) being treated with any anti-HCV regimen outside of a clinical trial Exclusion criteria: Inability to provide written informed consent Biorepository: baseline DNA and serum at key timepoints Serum at baseline and evidence of viral failure (non-response/breakthrough/relapse) DNA, single specimen at any time point Primary aims: Safety and efficacy in populations represented and underrepresented in phase III clinical trials African Americans / Hispanics, cirrhosis, null responders, age > 65, transplant Subgroup analyses to determine the cumulative influence of IL28B, fibrosis, viral subtype (1a vs 1b), other co-morbidities Prior DAA containing regimen failures Refine/Define point estimates and narrow/define confidence intervals for SVR Adverse event surveillance and management Drug-drug interactions Virologic breakthrough and resistance Biorepository sample collection Impact of viral load measurement on treatment efficacy Evaluate/inform FDA pharmacometric modeling Unstudied populations and dosing regimens Long Term Health Outcomes (annually after SVR determination) Impact of SVR/lack of SVR on HCV co-morbidities Persistence of existing co-morbid conditions Development of new co-morbid conditions Patient centered outcomes research Under development and to be piloted at select sites in 2015
		Hypothesis	A carefully maintained longitudinal, observational study of patients treated with telaprevir and boceprevir within academic and real-world community practices can rapidly inform strategies: For better management of populations both represented and underrepresented in Ph III clinical trials To identify educational gaps relative to treatment guidelines and management of adverse events To develop a core for translational studies To implement a rapid clinical trials network for novel studies