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

Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders Clinical Trial

— VBMI SUD/HCV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823457
• Other study ID #: 53635
• Status: Completed
• Phase: N/A
• Start date: April 5, 2017
• Est. completion date: January 30, 2020

Study information

• Verified date: January 2022
• Source: G.V. (Sonny) Montgomery VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• VBMI
12 week values based motivational interviewing intervention with a licensed psychologist

Locations

Country	Name	City	State
United States	GV Sonny Montgomery VAMC	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
G.V. (Sonny) Montgomery VA Medical Center	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Completion	Number of participants who completed treatment	12 weeks after initiation treatment
Secondary	Sustained Virologic Response	Number of participants who achieved SVR	an average of 3 months after treatment completion