Dataset Information

Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial

ABSTRACT: Abstract

Background

Young people who inject drugs (PWID) have high hepatitis C virus (HCV) incidence and low treatment initiation rates. 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 and Rapid Treatment” for curing HCV in young PWID.

Methods

Participants were recruited from the community and eligible if they were 18–29 years of age, HCV antibody-positive, treatment naive, and had injected drugs in the past 30 days. Participants were randomized 1:1 to “Rapid Treatment or Usual Care”. Participants randomized to Rapid Treatment received same-day medical evaluation, confirmatory and baseline laboratory testing, and a 7-day starter pack of sofosbuvir/velpatasvir at a syringe service program (SSP). Participants in “Usual Care” received same-day HCV confirmatory testing at the SSP and, if positive, facilitated referral to local providers. The primary endpoint was sustained virologic response at 12 weeks (SVR12) in HCV ribonucleic acid (RNA)+ participant.

Results

Forty-seven HCV antibody-positive participants were enrolled, and 25 participants had confirmed HCV and were included in the modified intention to treat analysis, with 9 of 14 (64%) of the Rapid Treatment arm and 1 of 11 (9.1%) of the Usual Care arm achieving a confirmed SVR12 (P = .01).

Conclusions

Among young HCV RNA+ PWID, significantly higher rates of cure were achieved using the Rapid Treatment model compared with facilitated referral. Providing easy access to HCV treatment for young PWID in low-threshold settings and initiating HCV treatment quickly appears to be a promising strategy for treating this hard-to-reach population. Rapid Treatment intervention with same-day prescription and dispensation of pan-genotypic DAA therapy was feasible, appeared to be accepted by participants, and resulted in substantially higher rates of treatment initiation, treatment completion, and cure, compared with the standard of care.

SUBMITTER: Eckhardt B

PROVIDER: S-EPMC9272437 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Hepatitis C virus (HCV) chronically infects over 180 million people worldwide, with over 350,000 estimated deaths attributed yearly to HCV-related liver diseases. It disproportionally affects people who inject drugs (PWID). Currently there is no preventative vaccine and interventions feature long treatment durations with severe side-effects. Upcoming treatments will improve this situation, making possible large-scale treatment interventions. How these strategies should target HCV-infected PWID remains an important unanswered question. Previous models of HCV have lacked empirically grounded contact models of PWID. Here we report results on HCV transmission and treatment using simulated contact networks generated from an empirically grounded network model using recently developed statistical approaches in social network analysis. Our HCV transmission model is a detailed, stochastic, individual-based model including spontaneously clearing nodes. On transmission we investigate the role of number of contacts and injecting frequency on time to primary infection and the role of spontaneously clearing nodes on incidence rates. On treatment we investigate the effect of nine network-based treatment strategies on chronic prevalence and incidence rates of primary infection and re-infection. Both numbers of contacts and injecting frequency play key roles in reducing time to primary infection. The change from "less-" to "more-frequent" injector is roughly similar to having one additional network contact. Nodes that spontaneously clear their HCV infection have a local effect on infection risk and the total number of such nodes (but not their locations) has a network wide effect on the incidence of both primary and re-infection with HCV. Re-infection plays a large role in the effectiveness of treatment interventions. Strategies that choose PWID and treat all their contacts (analogous to ring vaccination) are most effective in reducing the incidence rates of re-infection and combined infection. A strategy targeting infected PWID with the most contacts (analogous to targeted vaccination) is the least effective.