N/A N=20 Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT02823457 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Treatment Completion — 15 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: VBMI (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: G.V. (Sonny) Montgomery VA Medical Center
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Completion	15	—
SECONDARY Sustained Virologic Response	19	—

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.

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

View full record on ClinicalTrials.gov →

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.