Trial | NCT03364725  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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.
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:

Rate of sobriety maintenance for 1 year after enrollment
Re-infection rate with HCV over 1 year after enrollment
Re-admission rates for detox
Cravings
Study Started
Jan 15
2018
Anticipated
Primary Completion
Sep 01
2018
Anticipated
Study Completion
Mar 01
2019
Anticipated
Last Update
Dec 07
2017

Drug Glecaprevir-pibrentasvir [glecaprevir (Mavyret), pibrentasvir (Mavyret)]

Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.

Open Label Treatment Arm Experimental

Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients

Criteria 

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
No Results Posted