An Omnibus Protocol to Characterize Patients With Hepatitis B and C (the HOPE Study) With Hepatitis B Treatment Sub-study
University of Maryland, Baltimore
Summary
This is an observational, longitudinal, prospective study for sample collection and evaluation for future therapy or disease progression of chronic hepatitis B and C. Participants will be seen on an annual basis with optional additional visits for up to 10 years and provide samples for research and evaluation of disease progression. In addition, there is a longitudinal sub-study for treatment of hepatitis B that will involve 2 years of treatment with tenofovir alafenamide and blood collections with optional liver biopsies.
Description
Hepatitis B virus chronically infects 350 million people worldwide and over one million Americans and approximately 4.1 million individuals (1.6%) in the US population have been infected with hepatitis C. These infections are the leading cause of end-stage liver disease, cancer and indication for liver transplantation in the world. Both can be transmitted sexually, perinatally and percutaneously. Coinfected with human immunodeficiency virus (HIV) accelerates the progression of liver disease, and due to shared modes of transmission, chronic hepatitis B and C disproportionately affect people liv…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. At least 18 years old 2. Hepatitis B and/or C-infected; or history of hepatitis B infection, but cleared; or hepatitis C infection and successfully treated with direct acting antiviral agents, with or without HIV infection; or healthy volunteer without history of HBV and/or C, nor HIV 3. Willing to have samples stored for future research 4. Must have an identifiable primary care provider or be in the process of establishing a primary care provider 5. Willing to undergo HIV testing if not recently documented 6. Inclusion in the HBV treatment sub-study will be dependent o…
Interventions
- OtherBlood draws
- DrugTenofovir Alafenamide
25 mg tablet, once a day by mouth.
- OtherKnowledge Index Questionnaire
- OtherLiver transient elastography (FibroScan)
Participants of the hepatitis B treatment sub-study may have FibroScans completed at baseline, during the study with liver enzyme normalization, and at the end of the study.
- ProcedureLiver Biopsy
40 participants of the hepatitis B treatment sub-study will have liver biopsies prior to starting tenofovir alafenamide, and at years 1 and 2 of receiving treatment.
Locations (2)
- Institute of Human Virology, University of Maryland School of MedicineBaltimore, Maryland
- Dr Huong Dang, Medical PracticeFalls Church, Virginia