The PRIORITIZE Study: A pragmatic, randomized study of oral regimens for hepatitis C: Transforming decision-making for patients, providers, and stakeholders
Enrollment status: Actively enrolling
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.
Study design
- Subjects will be randomly assigned to one of three FDA approved oral medicines for hepatitis C: 1) Harvoni, 2) Viekira, or 3) Zepatier.
- Subjects will have up to 1 tablespoon of blood drawn for HCV resistance testing and future biorepository testing (if subject provides additional consent).
- Management during the course of treatment will be made by your liver doctor who will continue to be in charge of your care.
- Subjects will complete questionnaires before HCV treatment, during, at the end, and 1 and 3 years after treatment.
- Subjects will be compensated for their time and participation.
Principal investigator: Anna Lok, MD [email protected]
Contact person: Elizabeth Wu (734) 647-0236 or [email protected]
The Patient-Reported Outcomes Project of HCV-TARGET ("PROP UP")
Enrollment status: Actively enrolling
Objective
To collect important information directly from patients about their experiences with undergoing treatment for chronic hepatitis C. Patients will be asked to complete surveys before, during and after hepatitis C treatment. With the information collected on these surveys, the researchers can better answer the following questions:
- What types of symptoms do patients with hepatitis C experience?
- Do these symptoms go away or lessen if cured from hepatitis C?
- What type of side effects do patients experience on different treatments or do patients feel better on treatment?
- Does patient functioning and well-being change during and after treatment?
- What are the longer-term benefits and harms of treatment?
- Are there differences in how well patients take their pills on different treatments?
- Do different kinds of patients report different experiences during and after treatment?
Study design
- Survey completion at baseline, week 4 of treatment, end of treatment, 3 months post-treatment, and 1 year post-treatment
- Compensation provided
Principal Investigator: Anna Lok, MD [email protected]
Contact person: Elizabeth Wu (734) 647-0236 or [email protected]
Hepatitis C therapeutic registry and research network (HCV-TARGET) – a longitudinal, observational study
Enrollment status: Actively enrolling
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:
- Effectiveness of these drugs in differing patient populations
- Compare treatment durations in differing groups of patients
- How best to manage side effects
- Genetic variances in drug response
- Drug-to-drug interactions
- Patient education — group versus individual
- Pharmacy usage
- Drug resistance
Principal Investigator: Anna Lok, MD [email protected]
Contact person: Elizabeth Wu (734) 647-0236 or [email protected]
POLARIS-1
A phase 3, global, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety and efficacy of sofosbuvir/velpatasvir/GS-9857 fixed-dose combination for 12 weeks in direct-acting antiviral-experienced subjects with chronic HCV infection
Sponsor: Gilead
Enrollment status: Closed for enrollment, follow-up continuing
Objective
Safety and sustained virologic response rates of this three-drug combination
Inclusion criteria
- All HCV genotypes
- Previous treatment that included an NS5A inhibitor
- With or without cirrhosis
Exclusion criteria
- Liver failure
- Solid organ transplantation
- Significant medical or psychiatric illnesses
- Unable to comply with protocol and study visits
Study design
- Eligible genotype 1 patients randomized 1:1 to sofosbuvir/velpatasvir/GS-9857 fixed-dose combination for 12 weeks vs. deferred treatment (same regimen) until follow-up week 4 (i.e., 16 weeks from randomization)
- Eligible patients with other genotypes will not be randomized and will all start active treatment
- Follow-up visits until 24 weeks after completion of treatment
Note: study medications and tests associated with the study will be covered by sponsor.
Principal Investigator: Anna Lok, MD [email protected]
Contact person: Elizabeth Wu (734) 647-0236 or [email protected]
University of Michigan–Peking University Joint Initiative: Predictors of hepatitis C progression
Additional funding from the Bristol-Myers Squibb Foundation
Enrollment status: Closed for enrollment, follow-up continuing
Objective
To identify genetic markers that predict the progression from chronic HCV infection to cirrhosis and HCC, along with identifying and validating blood markers of liver fibrosis and early HCC.
Inclusion/exclusion criteria
- Adults with chronic hepatitis C, not currently taking antiviral medicine and no HIV coinfection.
Principal Investigator: Anna Lok, MD [email protected]
Contact persons:
Sherry Fu (734) 647-3635 or [email protected]
Elizabeth Wu (734) 647-0236 or [email protected]
Long-term follow-up of patients who received asunaprevir (BMS-650032) and/or daclatasvir (BMS-790052) in previous clinical trials
Enrollment status: Closed for enrollment, follow-up continuing
Objective
To determine the durability of virologic response in patients treated with asunaprevir and/or daclatasvir, assess the presence of HCV sequence variants, and characterize the long-term progression of liver disease.
Principal Investigator: Anna Lok, MD [email protected]
Contact person: Elizabeth Wu (734) 647-0236 or [email protected]
