VBMI to Increase Treatment Completion With MK-MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders Genotype 1 Chronic Hepatitis C



Status:Recruiting
Conditions:Psychiatric, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases, Psychiatry / Psychology
Healthy:No
Age Range:18 - 90
Updated:8/2/2017
Start Date:April 5, 2017
End Date:March 2019
Contact:Mary Burton, MD
Email:mary.burton2@va.gov
Phone:6013623371

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Evaluating Values-based Motivational Interviewing to Increase Treatment Completion With Fixed Dose Combination MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders and Treatment-naïve Genotype 1 Chronic Hepatitis C

This study implement a values-based motivational interviewing (VBMI) intervention to promote
treatment completion with fixed dose combination (FDC) MK-5172/MK-8742 x 12 weeks among 30
Veterans with substance use disorder (SUD) and treatment naïve genotype 1 chronic hepatitis C
virus (HCV) infection.

The investigators will conduct a prospective study of 30 Veterans with treatment-naive
genotype 1 chronic hepatitis C infection admitted to the Substance Abuse Residential
Rehabilitation Treatment Program (SARRTP) at the G.V. (Sonny) Montgomery VA Medical Center.
Enrolled veterans will be treated MK-5172/MI-8742 while receiving a 12 week values based
motivational intervention to promote completion of HCV treatment. MK-5172/MK-8742 will be
prescribed in accordance with the package insert.

Inclusion Criteria:

1. Identified as having treatment-naïve genotype 1 chronic HCV infection; Veterans who
are genotype 1a must have baseline NS5a resistance testing

2. Current resident of the SARRTP program

3. Willing to initiate treatment with FDC MK-5172/MK-8742 during SARRTP and up to 30 days
post-discharge.

4. Willing to attend coordinated HCV treatment clinic visits and substance abuse
aftercare visits every 2 weeks upon SARRTP discharge

Exclusion Criteria:

1. Contraindications for therapy with FDC MK-5172/MK-8742

2. Unable to provide written informed consent

3. Hepatocellular carcinoma or other medical condition precluding HCV treatment

4. Acute HCV infection

5. Prior treatment for chronic HCV

6. History of decompensated cirrhosis

7. Platelet count < 75 K/cmm and/or albumin < 3 grams/dL

8. Females and male sex partners of females who are pregnant, nursing and/or unwilling to
use contraception

9. Patients infected with genotype 1a who have not undergone baseline NS5a resistance
testing
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1
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Jackson, Mississippi 39216
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Jackson, MS
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