N/A
N=79
Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment
Hepatitis C · Depression · PTSD · Substance Use Disorder · Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02648022 ↗Enrolled (actual)
79
Serious AEs
17.7%
Results posted
May 2016
Primary outcome: Primary: Sustained Viral Response (SVR) — 30; 12.8 percentage of Participants — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief mental health interventions and case management (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Viral Response (SVR) |
30; 12.8 | 0.07 |
| SECONDARY Percentage of Participants With Treatment Initiation and Completion |
45; 23.1 | — |
| SECONDARY Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80% |
78; 63 | — |
Summary
To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02648022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.