Hepatitis C Treatment in PWIDs: MAT or Syringe Exchange Assisted-therapy vs Standard of Care
Hepatitis C, Substance Use Disorders, Substance Abuse, Intravenous
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, HCV, People Who Inject Drugs, PWID, Medication Assisted Therapy, MAT, Needle Exchange Program
Eligibility Criteria
Inclusion Criteria:
- Genotype 1b and genotype 1a without baseline NS5A resistance or Genotype 4
- APRI Score <0.7; if >0.7 a Fibrosure/Fibrotest or Fibroscan score of F2 or less
- No clinical or laboratory evidence of cirrhosis
- Readiness for treatment based on ability to make >2/3 sequential office visits
- Patients must be assessed to have decision-making capacity, be capable of consenting, and not be displaying evidence of overt intoxication.
Exclusion Criteria:
- Clinical or Laboratory Evidence of Cirrhosis
- Elevated prothrombin time unrelated to anticoagulation, hemoglobin level less than 12.3 g/L in females and <14 g/L in males, platelet count <150 × 109 cells/L), white blood cells (WBC) <4.0 x103/mm3 , aminotransferase levels more than 10 times the upper limit of normal, or albumin level <3.5 g/L.
- Previous treatment for hepatitis C infection
- Hepatocellular carcinoma
- HIV or hepatitis B virus co-infection
- Subjects taking medications that are contra-indicated to administer with Zepatier including phenytoin, carbamazepine, rifampin, St. John's Wort, and cyclosporine AND unable to change these medications to one without interactions.
Sites / Locations
- Old Town Clinic
- Outside In
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Other
Old Town Clinic, Medication Assisted Therapy group
Outside In Clinic, Needle Exchange Program
OHSU Hepatology Clinic, Academic center Retrospective Cohort
25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.
25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.
50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health & Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.