Quick HCV treatment with peer support boosts cure rates for drug users
NCT ID NCT04677153
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether offering rapid hepatitis C treatment with help from a peer mentor (someone who has been cured) works better than the usual referral to an outside clinic. 198 people who use drugs and were in an opioid treatment program took part. The goal was to see if more people start and finish treatment with the faster, supportive approach.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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198 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Sep 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ability and willingness of participant to provide written informed consent * Men and women age ≥18 to ≤70 years at study entry * HCV antibody positive/detectable HCV RNA * HCV treatment naïve (no prior treatment with an approved or investigational oral Direct-Acting Antivirals (DAA) therapy * Negative pregnancy test at screening or at the day of treatment initiation (females of childbearing potential only) * If co-infection with Human Immunodeficiency Virus (HIV) is documented, the subject must be anti-retroviral treatment (ART) naïve with CD4 T cell count \>500 cells/mm3 OR on a stable ART regimen (containing only permissible ART - Raltegravir; dolutegravir; Rilpivirine; Elvitegravir/cobicistat; Tenofovir disoproxil fumarate; Tenofovir alafenamide; Emtricitabine; Lamivudine and/or Abacavir, bictegravir) Exclusion Criteria: * Women who are pregnant or breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug * Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation * Current or history of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry * History of hepatocellular carcinoma (HCC) * Any history of active Hepatitis B or positive HBsAg test * Platelet count \< 150,000/mm3 * HCV RNA undetectable * History of clinically significant abnormalities or co-morbidities that make the subject an unsuitable candidate for this study, in the opinion of the investigator. * Women of childbearing potential that are not practicing at least one specified method of birth control that is effective from Study Day 1 through at least 30 days after the last dose of study drug. * Subject is currently taking any of the following prohibited medications: red yeast rice (monacolin K), St. John's Wort, carbamazepine, dabigatran, efavirenz, phenytoin, pentobarbital, phenobarbital, primidone, rifabutin, rifampin. * Subject is not able or willing to safely discontinue the prohibited medications or supplements listed below at least 14 days prior to the first dose of GLE/PIB: some HMG-CoA reductase inhibitors, astemizole, cisapride, terfenadine, ethinyl estradiol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Johns Hopkins University
Baltimore, Maryland, 21287, United States
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University Health Network Toronto
Toronto, Ontario, M5G 2C4, Canada
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University of Alabama
Birmingham, Alabama, 35294, United States
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University of California, San Francisco
San Francisco, California, 94143, United States