Clinical trial NCT04677153: Rapid HCV Treatment Access for Persons Who Use Drugs
Official title: Rapid HCV Test and Treat to Increase HCV Treatment Uptake Among People Who Use Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C Virus Infection, Response to Therapy of
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2020-12-21
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. 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.
2. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Participants Who Initiate HCV Therapy
timeFrame: Within 12 weeks of randomization
Secondary outcomes:
measure: HCV Treatment Completion
timeFrame: At expected end of treatment date, up to 20 weeks
measure: Sustained Virologic Response (SVR) Following Treatment by Intervention Group
timeFrame: Post-treatment week 12
measure: Time to HCV Treatment Initiation
timeFrame: From randomization to initiation of treatment, up to 36 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Toronto
country: Canada
facility: University Health Network Toronto
state: Ontario
Study officials:
affiliation: Johns Hopkins University
name: Oluwaseun Falade-Nwulia, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References: