Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study

Phase 4

• Conditions: Addict Heroin; Hepatitis C
• Interventions: Drug: Glecaprevir-pibrentasvir

• Registration Number: NCT03364725
• Lead Sponsor: Id Care

Brief Summary

To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.

Detailed Description

To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.

Primary objective:

1. Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years old

Secondary objectives:

1. Rate of sobriety maintenance for 1 year after enrollment

2. Re-infection rate with HCV over 1 year after enrollment

3. Re-admission rates for detox

4. Cravings

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-06
• Last Update Submitted: 2017-12-06
• Study First Posted: 2017-12-07
• Last Update Posted: 2017-12-07
• Study Start: 2018-01-15
• Primary Completion: 2018-09-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age 18 - 30
• Successfully detoxed at PHBH from opioids
• Agree to participate in a closely monitored program
• Positive HCV VL > 5,000 on two tests
• Minimum one follow-up visit after discharge from PHBH to be enrolled
• Any genotype
• APRI less than 1 and Fibrosure less than 0.45
• Negative pregnancy test in women and females must agree to acceptable contraception during treatment of HCV. Oral contraceptives that do not contain ethinyl estradiol are allowed with Mavyret
• Treatment naïve for HCV
• Signed informed consent

Exclusion Criteria

• Cirrhosis

• Co-infection with HIV or HBV

• Inability to comply with treatment or follow up

• Renal failure with GFR less than 50 mL/min5*

• Any prior treatment for HCV

• Diabetes with HgA1c more than 8.0

• Clinically significant abnormalities, other than HCV infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator, including, but not limited to:

  • ALT/AST > 10x normal value,
  • WBC with ANC < 1500 cell/ul,
  • Hemoglobin < LLN,
  • Treatment for cancer or lymphoma in the past 5 years,
  • Hemoglobin A 1C > 8%.

• Any uncontrolled psychiatric, cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric, or other medical disease or disorder, which is unrelated to the existing HCV infection which in the opinion of the PI would prevent adherence to and participation in the trial.

• Hypersensitivity to naltrexone or polylactide-co-glycolide (PLG) microspheres

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Treatment Arm	Glecaprevir-pibrentasvir	Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients

Primary Outcome Measures

Name	Time	Method
Cure rate of Hepatitis C Infection	12 weeks after treatment completion viral load measure	Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years

Secondary Outcome Measures

Name	Time	Method
Sobriety from Drug Use	1 year	Rate of sobriety maintenance for 1 year after enrollment
Hepatitis C Reinfection Rate	1 year	Re-infection rate with HCV over 1 year after enrollment

Trial Locations

Locations (1)

ID CARE; 🇺🇸 Hillsborough, New Jersey, United States