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

October 19, 2020 updated by: Andrew Seaman, Oregon Health and Science University

A Prospective Cohort Study Comparing the Effectiveness of Zepatier for the Treatment of Hepatitis C in an Academic Center Population to People Who Inject Drugs (PWIDs) in a Safety Net Clinic Setting Engaged in Either a Medication Assisted Therapy (MAT) or Syringe Exchange Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hepatitis C 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 hepatitis C virus (HCV) with elbasvir-grasoprevir in people who inject drugs (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 Academic Health Center.

All patients have genotype 1 or 4 HCV and are treated with elbasvir-grasoprevir for 12 weeks. The investigators exclude patients who: are under the age of 18; have a history of liver transplant; have failed past treatment of HCV; have an Aspartate aminotransferase Platelet Ratio Index (APRI) > 0.7 or APRI >0.7 but fibrosure/fibroscan of F2 or less; patients with genotype 1a and Nonstructural 5a (NS5a) resistance associated variants (RAVs); have clinical or radiologic evidence of cirrhosis; have aminotransferase levels >10x upper limit of normal; have a hemoglobin of less than 11g/dL, and are co-infected with hepatitis B or HIV.

The investigators hypothesize there is no difference in sustained viremic response at 12 or 48 weeks post-completion treatment (SVR 12, 48) when treating patients with a DAA in a community health clinic setting as compared to the standard-of-care subspecialty setting.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97214
        • Old Town Clinic
      • Portland, Oregon, United States, 97214
        • Outside In

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Old Town Clinic, Medication Assisted Therapy group
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.
Drug: elbasvir-grazoprevir (50 mg/100 mg)
12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Other Names:
  • Zepatier
ACTIVE_COMPARATOR: Outside In Clinic, Needle Exchange Program
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.
Drug: elbasvir-grazoprevir (50 mg/100 mg)
12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Other Names:
  • Zepatier
OTHER: OHSU Hepatology Clinic, Academic center Retrospective Cohort
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.
Drug: elbasvir-grazoprevir (50 mg/100 mg)
12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Other Names:
  • Zepatier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SVR 12
Time Frame: 24 weeks post-initiation of treatment (12 weeks post-completion of treatment)
Sustained Viremic Response at 12 weeks post-completion of treatment. SVR12 was determined negative if undetectable (<20 copies) by polymerase chain reaction and positive if EITHER loss-to-follow up and no lab data or virus was detected greater than 20 copies.
24 weeks post-initiation of treatment (12 weeks post-completion of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SVR 48
Time Frame: 60 weeks post-initiation of treatment (48 weeks post-completion of treatment)
Sustained Viremic Response at 48 weeks post-completion of treatment (SVR48). Participants "Achieving SVR48" had a negative hepatitis C real time polymerase chain reaction (RT-PCR) test at 48 weeks after end of treatment. Participants who "Did Not Achieve SVR48" had a positive hepatitis C RT-PCR test at 48 weeks after end of treatment.
60 weeks post-initiation of treatment (48 weeks post-completion of treatment)
Discontinuation Rate or Lost To Follow Up
Time Frame: Study duration (60 weeks)
Percentage of patients discontinuing medications prior to completion of 12 weeks or being lost to follow up, defined as inability to reach patient after 3 attempts and patients not following up with primary endpoint labs (SVR 12, 48)
Study duration (60 weeks)
NS5A Resistance
Time Frame: At Study Screening/Enrollment
Percentage of patients with genotype 1a and NS5A Resistance-Associated Variants (RAVs)
At Study Screening/Enrollment
Medication Adherence
Time Frame: 12 weeks (duration of treatment)
Adherence determined by client/subject self-reported medication adherence measured by percentage of pills taken on a monthly basis. Categorically separated into < 90% adherence, 90-99% adherence, 100% adherence.
12 weeks (duration of treatment)
Injection Drug Use Relapse (IDU)
Time Frame: Duration of study (60 weeks)
Self reported relapse IDU following HCV treatment (MAT arm)
Duration of study (60 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Atif Zaman, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 30, 2017

Primary Completion (ACTUAL)

June 6, 2019

Study Completion (ACTUAL)

June 6, 2019

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (ACTUAL)

March 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRS00002743

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All electronic data will be maintained encrypted in the Red Cap repository. Only the primary investigator and co-investigator will have access to the master spreadsheet linking study and personal identifiers. Andrew Seaman, co-investigator and primary study contact, will be listed as the repository guardian. He will be responsible for ensuring data are released according to OHSU policy and the institutional review board (IRB) approved repository protocol, executing a repository sharing agreement in case data are released for future research, ensuring the security and confidentiality of all stored data, ensuring the security and confidentiality of data, and tracking releases of data. The repository guardian will be responsible for verifying that future releases are done in concordance with pre-proposed limits and the original consent. Data transport at the time of any future IRB approved data sharing will be approved by an updated research services agreement and separate IRB approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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