This project is a randomized trial of two strategies to treat persons with genotype 1 HCV who currently inject drugs (PWIDs) with a once daily regime of ledipasvir-sofosbuvir (LDV-SOF) for 8 weeks. The study will enroll 30 participants and will assess the feasibility and acceptability of treating active PWIDs for HCV with LDV-SOF by modified directly observed therapy (mDOT) versus unobserved dosing, with motivational interviewing based adherence support; and assess through in-depth, semi-structured qualitative interviews, the challenges with time intensity required for mDOT and unobserved dosing interventions, and identify key factors affecting treatment adherence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Motivational Interviewing-based risk reduction and medication adherence counseling
Substance Use Research Unit
San Francisco, California, United States
Number of people who inject drugs (PWIDs) with HCV who were recruited and retained
To determine the feasibility of treating active PWIDs for HCV with LDV-SOF by mDOT versus unobserved dosing based on proportion eligible and enrolled among those screened and completion rates overall and by arm.
Time frame: 44 weeks
Medication adherence to study drug
To evaluate the acceptability of mDOT versus unobserved dosing, the percent of treatment medication adherence to LDV-SOF, as measured by the percent of doses taken overall (observed and unobserved), will be assessed using DOT doses and weekend Wise Pill data for the mDOT arm, and WisePill data for the unobserved dosing arm.
Time frame: 44 weeks
Challenges of medication adherence
To assess through in-depth, semi-structured qualitative interviews, the challenges with time intensity required for mDOT versus unobserved dosing for PWIDs treated with LDV-SOF.
Time frame: 44 weeks
SVR (end-of-treatment response)
We will compare the proportion of participants with undetectable HCV RNA at week 8 and post-treatment week 12 between arms.
Time frame: 12 weeks
SOF/metabolite levels
SOF/metabolite-positivity rates will be calculated by week in both arms.
Time frame: 8 weeks
HCV relapse and reinfection
Among participants who achieve SVR, we will determine the proportion who experience HCV relapse and reinfection at post-treatment week 36, overall and by arm.
Time frame: 36 weeks
Social and injector networks of participants
We will characterize injector network sizes at baseline and follow-up through ACASI surveys.
Time frame: 44 weeks
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