Hepatitis C Treatment in PWIDs: MAT or Syringe Exchange Assisted-therapy vs Standard of Care
Condition: Hepatitis C; Substance Use Disorders; Substance Abuse, Intravenous
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Substance-Related Disorders; Substance Abuse, Intravenous
Intervention: elbasvir-grazoprevir (50 mg/100 mg)
Intervention description: 12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Intervention MeSH terms: Grazoprevir; Elbasvir-grazoprevir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two parallel investigational groups in different community health clinic treatment settings assigned to treatment with elbasvir-grazoprevir as compared to an academic hepatology clinic retrospective cohort treated with elbasvir-grazoprevir.
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C; HCV; People Who Inject Drugs; PWID; Medication Assisted Therapy; MAT; Needle Exchange Program

Summary:

      hepatitis C virus (HCV) has traditionally been treated in subspecialty health centers given
      the complexity of older pegylated interferon containing regimens, formerly the standard of
      care. This model has persisted into the modern era of direct anti-viral agents (DAAs) despite
      their relative simplicity, creating a bottleneck of human resources necessary to fight the
      largest infectious epidemic in North America. In addition, stigma and fear over cost has lead
      payers to restrict treatment in People Who Inject Drugs (PWIDs), even though a majority of
      new infections occur in this population.

      This study evaluates the effectiveness of treatment of HCV with elbasvir-grasoprevir in PWIDs
      in a real world, community health clinic setting.

      There are two prospective cohorts of PWIDs of 25 patients each, both in primary care-based
      community health clinics in Portland, Oregon. Cohort one is actively engaged with ambulatory
      medication assisted therapy with buprenorphine or extended released injectable naltrexone.
      Cohort two maintains active injection drug use with needle exchange and risk reduction
      education.

      These groups are compared to a 50 patient retrospective cohort of people with substance use
      disorders at tertiary care hepatology-based treatment program.

      All patients have genotype 1 or 4 HCV and are treated with elbasvir-grasoprevir for 12 weeks.

      The investigators hypothesize there is no difference in sustained viremic response at 12 or
      48 weeks post-completion of treatment (SVR 12, 48) when treating patients in a community
      health clinic setting as compared to the standard-of-care subspecialty setting.
    

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.