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

• Sponsor: G.V. (Sonny) Montgomery VA Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02823457
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 33.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders	Behavioral: VBMI	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: open label
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 5, 2017
• Actual Primary Completion Date: Jan 30, 2020
• Actual Study Completion Date: Jan 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: VBMI intervention group All patients will receive a 12 week VBMI intervention to promote treatment completion	Behavioral: VBMI; 12 week values based motivational interviewing intervention with a licensed psychologist; Other Names: Values Based Motivational Interviewing

Outcome Measures

Primary Outcome Measures

1. Treatment Completion [12 weeks after initiation treatment]

   Number of participants who completed treatment

Secondary Outcome Measures

1. Sustained Virologic Response [an average of 3 months after treatment completion]

   Number of participants who achieved SVR

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GV Sonny Montgomery VAMC	Jackson	Mississippi	United States	39216

Sponsors and Collaborators

• G.V. (Sonny) Montgomery VA Medical Center
• Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: Mary Burton, MD, G.V. (Sonny) Montgomery VAMC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 10, 2019

More Information

Publications

None provided.

• Responsible Party: Mary Jane Burton, Staff Physician, G.V. (Sonny) Montgomery VA Medical Center
• ClinicalTrials.gov Identifier: NCT02823457
• Other Study ID Numbers: 53635
• First Posted: Jul 6, 2016
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Substance-Related Disorders; Alcohol-Related Disorders

Study Results

Participant Flow

Arm/Group Title	VBMI Intervention Group
Arm/Group Description	All patients will receive a 12 week VBMI intervention to promote treatment completion VBMI: 12 week values based motivational interviewing intervention with a licensed psychologist
Period Title: Overall Study
STARTED	20
COMPLETED	15
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	VBMI Intervention Group
Arm/Group Description	All patients will receive a 12 week VBMI intervention to promote treatment completion VBMI: 12 week values based motivational interviewing intervention with a licensed psychologist
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.0 (6.0)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	20 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	17 85%
White	3 15%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	Treatment Completion
Description	Number of participants who completed treatment
Time Frame	12 weeks after initiation treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VBMI Intervention Group
Arm/Group Description	All patients will receive a 12 week VBMI intervention to promote treatment completion VBMI: 12 week values based motivational interviewing intervention with a licensed psychologist
Measure Participants	20
Count of Participants [Participants]	15 75%

2. Secondary Outcome

Title	Sustained Virologic Response
Description	Number of participants who achieved SVR
Time Frame	an average of 3 months after treatment completion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VBMI Intervention Group
Arm/Group Description	All patients will receive a 12 week VBMI intervention to promote treatment completion VBMI: 12 week values based motivational interviewing intervention with a licensed psychologist
Measure Participants	20
Count of Participants [Participants]	19 95%

Adverse Events

Time Frame	Six months
Arm/Group Title	VBMI Intervention Group
Arm/Group Description	All patients will receive a 12 week VBMI intervention to promote treatment completion VBMI: 12 week values based motivational interviewing intervention with a licensed psychologist
All Cause Mortality
	VBMI Intervention Group
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	VBMI Intervention Group
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	VBMI Intervention Group
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.