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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-05

Study Completion Date

2020-01-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open label

Study Groups

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VBMI intervention group

All patients will receive a 12 week VBMI intervention to promote treatment completion

Group Type OTHER

VBMI

Intervention Type BEHAVIORAL

12 week values based motivational interviewing intervention with a licensed psychologist

Interventions

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VBMI

12 week values based motivational interviewing intervention with a licensed psychologist

Intervention Type BEHAVIORAL

Other Intervention Names

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Values Based Motivational Interviewing

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No