Rapid HCV Treatment Access for Persons Who Use Drugs

Hepatitis C Virus Infection, Response to Therapy of Clinical Trial

— RAPID-HCV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04677153
• Other study ID #: IRB00265240
• Status: Recruiting
• Phase: N/A
• Start date: August 6, 2021
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: Johns Hopkins University
• Contact: Oluwaseun Falade-Nwulia, MBBS, MPH
• Phone: 4422871964
• Email: ofalade1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus Infection, Response to Therapy of

Intervention

Other:
• Test and treat plus peer mentors
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.
• Usual care
Participants are referred to another location for HCV treatment.

Locations

Country	Name	City	State
Canada	University Health Network Toronto	Toronto	Ontario
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	AbbVie

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Who Initiate HCV Therapy	Proportion of participants who start HCV treatment in each arm.	Within 12 weeks of randomization
Secondary	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
Secondary	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
Secondary	Time to HCV Treatment Initiation	Time to HCV Treatment Initiation in weeks.	From randomization to initiation of treatment, up to 36 weeks