Hepatitis C


DAA Salvage B16-439: A phase 3b, multi-center, randomized, open-label, pragmatic study of glecaprevir/pibrentasvir (G/P) +/- ribavirin for GT1 subjects with chronic hepatitis C previously treated with an NS5A inhibitor + sofosbuvir therapy

Sponsor: University of Florida / AbbVie

Enrollment status: CLOSED. Follow-up ongoing

Objective

Safety and sustained virologic response rates of glecaprevir/pibrentasvir (G/P).

Inclusion criteria

Exclusion criteria

Study design

Principal investigator: Anna Lok, MD, aslok@med.umich.edu

Contact person: Sravanthi Kaza, (734) 615-3853 or sravanth@med.umich.edu


The PRIORITIZE Study: A pragmatic, randomized study of oral regimens for hepatitis C: Transforming decision-making for patients, providers, and stakeholders

Sponsor: University of Florida / Patient-Centered Outcomes Research Institute (PCORI)

Enrollment status: CLOSED. Follow-up ongoing

Objective

PRIORITIZE will be able to compare the effectiveness of FDA-approved medicines for HCV, side effects reported by patients, treatment adherence, and to see if patients' liver disease improves or worsens after treatment.

Inclusion criteria

Exclusion criteria

Study design

Principal investigator: Anna Lok, MD, aslok@med.umich.edu

Contact person: Christopher Foster, (734) 615-3853 or fostchj@med.umich.edu


Hepatitis C therapeutic registry and research network (HCV-TARGET) – a longitudinal, observational study

Sponsor: University of Florida, University of North Carolina

Enrollment status: OPEN

Eligibility criteria

Objective

To collect and study information on patients with chronic hepatitis C virus who are being treated with direct-acting antiviral agents in a “real world” patient population to determine:

Principal investigator: Anna Lok, MD, aslok@med.umich.edu

Contact person: Christopher Foster, (734) 615-3853 or fostchj@med.umich.edu