Rapid Hepatitis C Treatment Initiation in Young People who Inject Drugs: Final Results From The HCV-Seek, Test & Rapid Treatment (HCV-ST&RT) Randomized Pilot Clinical Trial.

Author: Benjamin Eckhardt Shashi Kapadia Melinda Pai Yesenia Aponte-Melendez Chunkio Fong La Davis Pedro Mateu-Gelabert Kristen Marks

Theme: Clinical Research Year: 2022

Young people who inject drugs (PWID) have higher HCV incidence and lower treatment initiation rates
compared to their older peers. Novel, simplified care models need to be developed to engage, treat and
cure hard to reach patient populations, such as young PWID.

We present final data from the randomized pilot clinical trial HCV-Seek Test & Rapid Treatment (HCVST&RT) for curing HCV in young PWID. Eligible participants were 18-29 years of age, HCV Ab+,
treatment naïve, and had injected drugs in the past 30 days. Participants randomized to Rapid
Treatment received a same-day medical evaluation, confirmatory and baseline lab testing, and 7-day
starter pack of sofosbuvir/velpatasvir. Participants in Usual Care received same-day HCV confirmatory
testing and, if positive, facilitated referral to local providers. The primary endpoint was sustained
virologic response (SVR12) in RNA+ participant within 12 months of enrollment.

Among 47 eligible participants, 39 were enrolled, with 1 excluded post-randomization for prior
treatment (N=38). 14/18 in the Rapid Treatment arm and 11/20 in the Usual Care arm were confirmed
HCV RNA+ and included in the intention-to-treat analysis. The mean age was 26 years; 24% women. At
baseline 24% were homeless, 52% received medication for opioid use disorder in the prior 90 days, and
participants injected a median of 20 of the last 30 days. In the intention-to-treat analysis, 9/14 (64%) of
the Rapid Treatment arm and 2/11 (18%) of the Usual Care arm had confirmed SVR12 (p=0.042).

Among young HCV RNA+ PWID, significantly higher rates of cure were achieved using the Rapid
Treatment model with same day, low-threshold, simplified HCV care compared to facilitated referral.
Meeting young PWID where they’re at and initiating HCV treatment ‘in the moment’ without the need
for repeat visits appears to be a promising strategy for treating this hard to reach population.

Disclosure of Interest Statement:
This research was funded with grant support from Gilead Sciences

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