Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Mandana Khalili

Description

Summary

Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to learn whether they work equally well under real-world conditions. Phase 2 of this study will begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments. Patients receiving HCV therapy in community and academic clinics will be offered the opportunity to consent to be randomly assigned to one of three regimens and then observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management will be assumed by usual care conditions, and patient-reported outcomes will be collected outside clinic in keeping with pragmatic design principles.

Official Title

THE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders

Details

In Phase 1 of this study, consented subjects will be randomized to 1 of the following 3 HCV treatments:

1) Harvoni® 2)Viekira Pak™ 3)Zepatier™ (The addition of Ribavirin and the length of treatment will be determined by the provider). In Phase 2 of this study, consented subjects will be randomized to 1 of 2 FDA approved HCV treatments: 1)1) Harvoni® or 3)Zepatier™. Both Phase 1 and Phase 2 subjects will have up to 1 tablespoon of blood drawn for HCV resistance testing and future biorepository testing (if subject provides additional consent). The results of testing will determine whether a genotype 1a subject will be provided 12 or 16 wks of Zepatier (if randomized to Zepatier).

Following randomization, subjects will complete patient reported outcome questionnaires via electronic device or telephone. Following randomization, subjects will be asked to complete surveys again at Wk 4 of treatment, End of Treatment, 1 and 3 year post treatment. Subjects standard medical care will continue. Test results and medical records throughout treatment and for up to 3 years post treatment will be collected.

Keywords

Chronic Hepatitis C Hepatitis C Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C, Chronic Ribavirin Ritonavir Sofosbuvir Ledipasvir sofosbuvir/ledipasvir ombitasvir/paritaprevir/ritonavir (Phase 1 only) elbasvir/grazoprevir Dasabuvir elbasvir/grazoprevir tablet

Eligibility

You can join if…

Open to people ages 18 years and up

  • HCV Genotype 1a or 1b
  • Adult patients (age 18 years or older)
  • Patients being prescribed HCV treatment who can begin treatment with any of the three HCV treatments being studied (Harvoni, Viekira Pak (Phase 1 only), or Zepatier)

You CAN'T join if...

  • Inability to provide written informed consent
  • HARVONI® is not a covered drug on benefits formulary
  • Current or historical evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy, or ascites)
  • Child Pugh (CTP) B or C Cirrhosis (documented CTP calculation is required)
  • Pregnant or breastfeeding women

Locations

  • UCSF/Zuckerberg San Francisco General Hospital and Trauma Center
    San Francisco California 94110 United States
  • Univ of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist

  • Mandana Khalili
    Co-Director, Clinical and Translational Science Institute (CTSI)-Comprehensive Mentoring Program My research focuses on natural history of chronic viral hepatitis (hepatitis B and hepatitis C), novel treatments for viral hepatitis, health services/health disparity in viral hepatitis, and evaluation of metabolic abnormalities and pathophysiology of diabetes within the context of hepatitis C and B.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Florida
ID
NCT02786537
Phase
Phase 4
Study Type
Interventional
Last Updated