- 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
