Hepatitis C Virus Infection, Response to Therapy of
Conditions
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.
Interventions
OTHERTest 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.
OTHERUsual care
Participants are referred to another location for HCV treatment.
Sponsors
Johns Hopkins University
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Initiate HCV Therapy | Within 12 weeks of randomization | Participants who start HCV treatment in each arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCV Treatment Completion | At expected end of treatment date, up to 20 weeks | Participants who start HCV treatment and subsequently complete treatment (take more than 90% of prescribed treatment course). |
| Sustained Virologic Response (SVR) Following Treatment by Intervention Group | Post-treatment week 12 | Participants in each arm who achieved SVR, defined as HCV RNA \<15 IU/mL between 10 and 36 weeks after completion of the HCV treatment regimen. |
| Time to HCV Treatment Initiation | From randomization to initiation of treatment, up to 24 weeks | Time to HCV Treatment Initiation in weeks. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATOROluwaseun Falade-Nwulia, MBBS, MPH
Johns Hopkins University
Participant flow
Recruitment details
Participants were recruited at five community sites - four in the United States and one in Canada. All sites were Opioid Treatment Programs (OTPs). Participants were recruited through staff referrals, on-site table events manned by research staff, as well as recruitment flyers and self-referrals.
Pre-assignment details
198 participants were screened and consented. 16 participants were ineligible for randomization (for 3 participants, they were unable to collect blood, 12 participants had undetectable HCV RNA, and 1 participant was excluded per investigator decision). The remaining 182 were randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47.5 Years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Injection drug use reported in the past 30 days | 34 Participants |
| Positive urine drug screen results at baseline - Any drug | 42 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Region of Enrollment Canada | 16 Participants |
| Region of Enrollment United States | 106 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 1 / 89 |
| other Total, other adverse events | 0 / 91 | 0 / 89 |
| serious Total, serious adverse events | 0 / 91 | 0 / 89 |
Outcome results
None listed