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

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 randomi...

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Autores principales: Eckhardt, Benjamin, Kapadia, Shashi N, Mateu-Gelabert, Pedro, Pai, Melinda, Fong, Chunki, Aponte-Melendez, Yesenia, Marks, Kristen M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9272437/
https://www.ncbi.nlm.nih.gov/pubmed/35821731
http://dx.doi.org/10.1093/ofid/ofac225
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author Eckhardt, Benjamin
Kapadia, Shashi N
Mateu-Gelabert, Pedro
Pai, Melinda
Fong, Chunki
Aponte-Melendez, Yesenia
Marks, Kristen M
author_facet Eckhardt, Benjamin
Kapadia, Shashi N
Mateu-Gelabert, Pedro
Pai, Melinda
Fong, Chunki
Aponte-Melendez, Yesenia
Marks, Kristen M
author_sort Eckhardt, Benjamin
collection PubMed
description 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.
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spelling pubmed-92724372022-07-11 Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial Eckhardt, Benjamin Kapadia, Shashi N Mateu-Gelabert, Pedro Pai, Melinda Fong, Chunki Aponte-Melendez, Yesenia Marks, Kristen M Open Forum Infect Dis Major Article 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. Oxford University Press 2022-05-07 /pmc/articles/PMC9272437/ /pubmed/35821731 http://dx.doi.org/10.1093/ofid/ofac225 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Major Article
Eckhardt, Benjamin
Kapadia, Shashi N
Mateu-Gelabert, Pedro
Pai, Melinda
Fong, Chunki
Aponte-Melendez, Yesenia
Marks, Kristen M
Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial
title Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial
title_full Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial
title_fullStr Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial
title_full_unstemmed Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial
title_short Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial
title_sort rapid treatment initiation for hepatitis c in young people who inject drugs: the seek, test, and rapid treatment randomized trial
topic Major Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9272437/
https://www.ncbi.nlm.nih.gov/pubmed/35821731
http://dx.doi.org/10.1093/ofid/ofac225
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