Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment

Background and aims: Approval of direct acting antiviral (DAA) therapies in 2011 initiated a
new era of more effective treatments for hepatitis C (HCV). The impact of more effective
therapies on patient access to treatment is unknown. Integrated Care (IC) involving patient
case management may overcome barriers to treatment access imposed by psychiatric and
substance use disorders (SUD).

Methods: Prospective, randomized trial at a single medical center. Patients with HCV at risk
for active psychiatric and SUD between Jan 2012 and Jan 2013 were recruited and randomized
to IC or Usual Care (UC). A mid-level mental health practitioner was placed in the IC clinic
and provided brief mental health care and case management.

Inclusion Criteria:

- Patients with HCV infection who were referred to the VA HCV clinic and who received
the usual initial evaluation in the clinic

- All patients 18 and 75 years old with confirmed HCV infection

- Patients were required to be classified as "high risk candidates for antiviral
treatment" on any one of a set of screening measure in order to participate

- Screening measures and cutoffs for inclusion were depression:

- Beck Depression Inventory: (BDI) > 10

- Alcohol use: Alcohol Use Disorders Identification Test (AUDIT-C) > 4

- PTSD: VA Primary Care PTSD Screen = endorsement of three or more items or any
single endorsement of item #3

- Drug use: Drug Use Questionnaire = self-reported drug/alcohol use within 6
months prior to screen

Exclusion Criteria:

- Lacked a confirmed test of HCV RNA

- Had HIV/HCV co-infection and received care at San Diego or Palo Alto sites (these
patients were treated in a separate clinic)

- Had Hepatitis B (HBV) co-infection

- Had decompensated liver disease with active or recent encephalopathy, variceal
bleeding, or ascites or Child-Pugh class B or C

- Had other significant near term life-threatening diseases

- Were treatment non-responders with pegylated Interferon plus ribavirin