Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior

Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The
development of directly acting antivirals (DAA) has dramatically improved the cure rate of
HCV treatment. However, despite the availability of effective therapy, the global epidemic of
HCV infection continues to be driven by people with ongoing injection drug use (PWID), who
are largely excluded from HCV therapy. Several critical barriers exist preventing high-risk
patients' entry to care, including (1) lack of engagement in the traditional healthcare
system by marginalized patient populations, and (2) insurance restrictions due to concerns
regarding treatment adherence and HCV reinfection. Furthermore, ongoing injection drug use
places these individuals at high risk of HIV acquisition. However, studies have repeatedly
demonstrated that pre-exposure prophylaxis (PrEP) reduces HIV acquisition and opioid
substitution therapy with buprenorphine reduces HIV and HCV acquisition in PWID.

As such, we propose a comprehensive model of care to engage individuals with ongoing
injection drug use in treatment of HCV, in conjunction with collocated services to prevent
HIV acquisition and HCV reinfection, including pre-exposure prophylaxis and opioid
substitution therapy. This pilot trial will demonstrate whether a comprehensive model of care
can simultaneously treat HCV, and prevent HCV reinfection, HIV acquisition and effectively
treat opioid use disorder.

Inclusion Criteria:

1. Age 18 years old

2. Able and willing to sign informed consent

3. Chronically infected with HCV, defined as any individual with documentation of
positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).

4. Willing to have samples stored for future use

5. Ongoing injection drug use, defined as self-report of injection non-prescription drug
use within three months of screening visit

Exclusion Criteria:

1. Decompensated liver disease (Childs Pugh B or C)

2. Unable to comply with research study visits

3. Poor venous access not allowing screening laboratory collection

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

5. Pregnant or breastfeeding woman