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

Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study Combining HCV and Addiction Treatment of Young Suburban Heroin Users (SHU) That Addresses Barriers to Care

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.

Study Overview

• Status: Unknown
• Conditions: Hepatitis C; Addict Heroin
• Intervention / Treatment: Drug: Glecaprevir-pibrentasvir

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ronald Nahass, MD; Phone Number: 9082810221; Email: rnahass@idcare.com
• Study Contact Backup: Name: Kathleen Seneca, MSN, APN; Phone Number: 9082810221; Email: kseneca@idcare.com

Study Locations

• United States
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
      • ID Care
      • Contact: Kathleen Seneca, MSN, APN; Phone Number: 9082810221; Email: kseneca@idcare.com
      • Contact: Ronald Nahass, MD; Phone Number: 908-281-0221; Email: rnahass@idcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Label Treatment Arm; Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients	Drug: Glecaprevir-pibrentasvir; Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure rate of Hepatitis C Infection	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	12 weeks after treatment completion viral load measure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Id Care
• Collaborators: AbbVie
• Investigators: Principal Investigator: Ronald Nahass, MD, ID Care

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2018
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: IIS # 11-507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No