Theme: Clinical Research Year: 2019
Disclosure of Interest Statement: The current work is funded by Gilead Sciences Inc. Additionally Dr.
Eckhardt has received research grants to NYU from Gilead Sciences Inc unrelated to the current work.
Dr. Marks has received research grants to Weill Cornell from Gilead Sciences, BMS, and Merck unrelated
to the current work. All other authors have no potential conflicts of interest to disclose.
Background: The conventional approach to HCV treatment in the United States (US) involves multiple
medical visits and time waiting for medication approval, which may especially deter young people who
inject drugs (PWID). We designed a community-based, rapid-treatment intervention (HCV-ST&RT) for
young PWID. This abstract presents the design, recruitment, and characteristics of participants enrolled.
Methods: HCV-ST&RT is a pilot randomized controlled trial. Eligible participants are aged 18-29, have
injected drugs in the past 30 days, HCV-antibody positive and HCV-treatment naïve. The intended
sample size is 72. Participants randomized to the intervention arm receive a medical evaluation on-site
at a syringe services program and a 7-day starter pack of sofosbuvir/velpatasvir. After results of
laboratory testing, HCV RNA positive participants with no contraindications are instructed to start
treatment and scheduled for follow-up. Participants in the control arm are offered care coordination
and facilitated referral to local treatment sites. All participants complete surveys and HCV RNA PCR at
baseline and every 3 months through one year of follow up.
Results: 25 participants screened eligible, and 22 have enrolled. The median age is 26. There are 16
male and 6 female participants. 18/22 had positive HCV RNA at baseline. All 22 injected heroin, 14 also
injected cocaine. Participants injected a median of 20 days in the past month, and 14 shared injection
equipment in that time. Most (19/22) participants have health insurance, with 18 on Medicaid. 13 were
in substance use treatment in the past 3 months. Most (18/22) had been tested for HCV before, but 10
were previously unaware of their positive HCV antibody status.
Conclusions: Young, high-risk PWID with hepatitis C, many of whom are newly diagnosed, are being
enrolled in a clinical trial of rapid-start HCV therapy. If effective, this strategy may further lower the
barrier for HCV treatment for this population.