Clinical trial NCT02823457: VBMI to Increase Treatment Completion With MK-MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders Genotype 1 Chronic Hepatitis C
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders
Lead sponsor: G.V. (Sonny) Montgomery VA Medical Center
Sponsor class: FED
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-07-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment Completion
timeFrame: 12 weeks after initiation treatment
Secondary outcomes:
measure: Sustained Virologic Response
timeFrame: an average of 3 months after treatment completion
Other outcomes:
Locations:
city: Jackson
country: United States
facility: GV Sonny Montgomery VAMC
state: Mississippi
Study officials:
affiliation: G.V. (Sonny) Montgomery VAMC
name: Mary Burton, MD
role: PRINCIPAL_INVESTIGATOR
References: