Rapid HCV Treatment Access for Persons Who Use Drugs

Study Overview
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Brief Summary
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This study is being done to compare two strategies to deliver HCV treatment to persons with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient opioid treatment program (OTP). Participants will be randomized into one of two treatment groups: Test and treat plus peer-mentors: This treatment group will be offered 8 weeks of glecaprevir/pibrentasvir (an FDA approved HCV treatment) within days of HCV diagnosis at the OTP. Participants in this group will receive treatment adherence support from a peer-mentor who is someone who has been cured of HCV infection. Standard of care HCV treatment referral: This treatment group will be referred to an offsite HCV treatment location. This is the usual care for anyone who tests positive for HCV at the OTP who is not participating in this study.

Official Title
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Rapid HCV Test and Treat to Increase HCV Treatment Uptake Among People Who Use Drugs

Conditions
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Hepatitis C Virus Infection, Response to Therapy of

Intervention / Treatment
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* Other: Test and treat plus peer mentors
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test and Treat plus Peer Mentors Intervention Arm<br>Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support. | Other: Test and treat plus peer mentors<br>* Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.<br>* Other names: On-site treatment with peer support HCV treatment implementation strategy;|
| Active Comparator: Standard of Care Referral Arm<br>Participants referred to offsite (non-OTP) location for HCV treatment. | Other: Usual care<br>* Participants are referred to another location for HCV treatment.<br>* Other names: Standard of care referral HCV treatment implementation strategy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Who Initiate HCV Therapy | Proportion of participants who start HCV treatment in each arm. | Within 12 weeks of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV Treatment Completion | Proportion of participants who start HCV treatment and subsequently complete treatment (take more than 90% of prescribed treatment course). | At expected end of treatment date, up to 20 weeks | 
| Sustained Virologic Response (SVR) Following Treatment by Intervention Group | Proportion of participants in each arm who achieved SVR, defined as HCV RNA <15 IU/mL between 10 and 36 weeks weeks after completion of the HCV treatment regimen. | Post-treatment week 12 | 
| Time to HCV Treatment Initiation | Time to HCV Treatment Initiation in weeks. | From randomization to initiation of treatment, up to 36 weeks |