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Trial record 56 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03093415
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Seaman, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE March 9, 2017
First Posted Date  ICMJE March 28, 2017
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE May 30, 2017
Actual Primary Completion Date June 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03093415 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • 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
  • Discontinuation Rate / 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)
  • NS5A Resistance [ Time Frame: At Study Screening/Enrollment ]
    Percentage of patients with genotype 1a and NS5A Resistance-Associated Variants (RAVs)
  • 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, as well as adherence with laboratory testing
  • Injection Drug Use Relapse [ Time Frame: Duration of study (60 weeks) ]
    Self reported relapse IDU following HCV treatment (MAT arm)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hepatitis C Treatment in PWIDs: MAT or Syringe Exchange Assisted-therapy vs Standard of Care
Official Title  ICMJE 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
Brief 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.

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 AST Platelet Ratio Index (APRI) > 0.7 or APRI >0.7 but fibrosure/fibroscan of F2 or less; patients with genotype 1a and NS5a resistance 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C
  • Substance Use Disorders
  • Substance Abuse, Intravenous
Intervention  ICMJE Drug: elbasvir-grazoprevir (50 mg/100 mg)
12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Other Name: Zepatier
Study Arms  ICMJE
  • 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.
    Intervention: Drug: elbasvir-grazoprevir (50 mg/100 mg)
  • 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.
    Intervention: Drug: elbasvir-grazoprevir (50 mg/100 mg)
  • OHSU Hepatology Clinic, Academic center Retrospective Cohort
    50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.
    Intervention: Drug: elbasvir-grazoprevir (50 mg/100 mg)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2017)
100
Actual Study Completion Date  ICMJE June 6, 2019
Actual Primary Completion Date June 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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), 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03093415
Other Study ID Numbers  ICMJE CRS00002743
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All electronic data will be maintained encrypted in the Red Cap repository, devoid of HIPPA identifiers. Only the primary investigator and co-investigator will have access to the master spreadsheet linking study ID 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 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 acquisitions and 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 RSA and separate IRB approval.
Responsible Party Andrew Seaman, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Atif Zaman, MD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP