N/A
Completed N=20
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
Source: ClinicalTrials.gov NCT02823457 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Treatment Completion — 15 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Completion |
15 | — |
| SECONDARY Sustained Virologic Response |
19 | — |
Eligibility Criteria
Inclusion Criteria
- Identified as having treatment-naïve genotype 1 chronic HCV infection; Veterans who are genotype 1a must have baseline NS5a resistance testing
- Current resident of the SARRTP program
- Willing to initiate treatment with FDC MK-5172/MK-8742 during SARRTP and up to 30 days post-discharge.
- Willing to attend coordinated HCV treatment clinic visits and substance abuse aftercare visits every 2 weeks upon SARRTP discharge
Exclusion Criteria
- Contraindications for therapy with FDC MK-5172/MK-8742
- Unable to provide written informed consent
- Hepatocellular carcinoma or other medical condition precluding HCV treatment
- Acute HCV infection
- Prior treatment for chronic HCV
- History of decompensated cirrhosis
- Platelet count < 75 K/cmm and/or albumin < 3 grams/dL
- Females and male sex partners of females who are pregnant, nursing and/or unwilling to use contraception
- Patients infected with genotype 1a who have not undergone baseline NS5a resistance testing
Data sourced from ClinicalTrials.gov (NCT02823457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.