The HOPE Study: Characterizing Patients With Hepatitis B and C

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 living with HIV.

The primary objective of this study is to Identify people with viral hepatitis and providing
linkage to care and future therapy with evaluation of disease progression; as well as
characterizing those with hepatitis B and those treated for hepatitis C with directly acting
antivirals over the course of 10 years.

The study, including a participant questionnaire and phlebotomy, will be administered on-site
at clinical facilities in the District of Columbia and Maryland, and at the Institute of
Human Virology at the University of Maryland, Baltimore. The cohort will be designed to study
research questions with respect to liver disease, disease pathogenesis using genomics,
proteomics, and immunologic disease models. Secondary objectives include study of the
immunopathogenesis of hepatitis B and C disease progression. In addition, this is an
invaluable opportunity to evaluate the long term effects of hepatitis C clearance with direct
acting antivirals, along with biomarker profile(s) for diagnosis and outcome. Moreover, this
will serve as a catchment protocol to select appropriate participants for novel hepatitis B
and C therapeutic trials.

This study includes a standard-of-care treatment sub-study for patients with hepatitis B. In
this sub-study, participants will receive an approved nucleos(t)ide analogue prospectively
observed on therapy for change in liver fibrosis.

The integrated clinics will provide an optimal environment for the adherence and engagement
of medical care and education in decreasing transmission risks of infection. The study will
establish a blood and specimen repository for participants and include a research database
that will be used prospectively to test future hypotheses.

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 on eligibility to receive
nucleos(t)ide analogue therapy according to standard-of-care.

Exclusion Criteria:

1. Unable to comply with research study visits

2. Poor venous access not allowing screening laboratory collection

3. Have any condition that the investigator considers a contraindication to study
participation.

4. HBV monoinfected participants with any contraindications to HBV treatment with
nucleos(t)ide analogues will be ineligible to participate in the HBV treatment
sub-study.

5. Pregnant or breastfeeding women will not be eligible to participate in the HBV
treatment sub-study