Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders
Conditions
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.
Interventions
BEHAVIORALVBMI
12 week values based motivational interviewing intervention with a licensed psychologist
Sponsors
Merck Sharp & Dohme LLC
G.V. (Sonny) Montgomery VA Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Completion | 12 weeks after initiation treatment | Number of participants who completed treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virologic Response | an average of 3 months after treatment completion | Number of participants who achieved SVR |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VBMI Intervention Group 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | VBMI Intervention Group |
|---|---|
| Age, Continuous | 65.0 years STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Treatment Completion
Number of participants who completed treatment
Time frame: 12 weeks after initiation treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VBMI Intervention Group | Treatment Completion | 15 Participants |
Secondary
Sustained Virologic Response
Number of participants who achieved SVR
Time frame: an average of 3 months after treatment completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VBMI Intervention Group | Sustained Virologic Response | 19 Participants |