Hepatitis C Treatment in PWIDs: MAT or Syringe Exchange Assisted-therapy vs Standard of Care

Completed · Phase 4

Conditions studied: Hepatitis C, Substance Use Disorders, Substance Abuse, Intravenous

In brief

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.

Key facts

Study ID: NCT03093415
Run by: Oregon Health and Science University
People needed: 100
Starts: 2017-05-30
Expected to finish: 2019-06-06
Last updated by the study team: 2020-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Old Town Clinic — Portland, Oregon, United States
Outside In — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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