Clinical trial NCT03364725: Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis C
Addict Heroin
Lead sponsor: Id Care
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2017-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Cure rate of Hepatitis C Infection
timeFrame: 12 weeks after treatment completion viral load measure
Secondary outcomes:
measure: Sobriety from Drug Use
timeFrame: 1 year
measure: Hepatitis C Reinfection Rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Hillsborough
country: United States
facility: ID CARE
state: New Jersey
Study officials:
affiliation: Id Care
name: Ronald Nahass, MD
role: PRINCIPAL_INVESTIGATOR
References: