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

Primary Purpose

Hepatitis C, Substance Use Disorders, Substance Abuse, Intravenous

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
elbasvir-grazoprevir (50 mg/100 mg)
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Old Town Clinic, Medication Assisted Therapy group

Outside In Clinic, Needle Exchange Program

OHSU Hepatology Clinic, Academic center Retrospective Cohort

Arm Description

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.

Outcomes

Primary Outcome Measures

SVR 12
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.

Secondary Outcome Measures

SVR 48
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.
Discontinuation Rate or Lost To Follow Up
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
Percentage of patients with genotype 1a and NS5A Resistance-Associated Variants (RAVs)
Medication Adherence
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.
Injection Drug Use Relapse (IDU)
Self reported relapse IDU following HCV treatment (MAT arm)

Full Information

First Posted
March 9, 2017
Last Updated
October 19, 2020
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03093415
Brief Title
Hepatitis C Treatment in PWIDs: MAT or Syringe Exchange Assisted-therapy vs Standard of Care
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Substance Use Disorders, Substance Abuse, Intravenous
Keywords
Hepatitis C, HCV, People Who Inject Drugs, PWID, Medication Assisted Therapy, MAT, Needle Exchange Program

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Old Town Clinic, Medication Assisted Therapy group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Outside In Clinic, Needle Exchange Program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
OHSU Hepatology Clinic, Academic center Retrospective Cohort
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
elbasvir-grazoprevir (50 mg/100 mg)
Other Intervention Name(s)
Zepatier
Intervention Description
12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Primary Outcome Measure Information:
Title
SVR 12
Description
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.
Time Frame
24 weeks post-initiation of treatment (12 weeks post-completion of treatment)
Secondary Outcome Measure Information:
Title
SVR 48
Description
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.
Time Frame
60 weeks post-initiation of treatment (48 weeks post-completion of treatment)
Title
Discontinuation Rate or Lost To Follow Up
Description
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)
Time Frame
Study duration (60 weeks)
Title
NS5A Resistance
Description
Percentage of patients with genotype 1a and NS5A Resistance-Associated Variants (RAVs)
Time Frame
At Study Screening/Enrollment
Title
Medication Adherence
Description
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.
Time Frame
12 weeks (duration of treatment)
Title
Injection Drug Use Relapse (IDU)
Description
Self reported relapse IDU following HCV treatment (MAT arm)
Time Frame
Duration of study (60 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atif Zaman, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Old Town Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
Outside In
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
22938915
Citation
Islam MM, Topp L, Conigrave KM, White A, Reid SE, Grummett S, Haber PS, Day CA. Linkage into specialist hepatitis C treatment services of injecting drug users attending a needle syringe program-based primary healthcare centre. J Subst Abuse Treat. 2012 Dec;43(4):440-5. doi: 10.1016/j.jsat.2012.07.007. Epub 2012 Aug 29.
Results Reference
background
PubMed Identifier
23884067
Citation
Bruggmann P, Litwin AH. Models of care for the management of hepatitis C virus among people who inject drugs: one size does not fit all. Clin Infect Dis. 2013 Aug;57 Suppl 2(Suppl 2):S56-61. doi: 10.1093/cid/cit271.
Results Reference
result
PubMed Identifier
23884071
Citation
Aspinall EJ, Corson S, Doyle JS, Grebely J, Hutchinson SJ, Dore GJ, Goldberg DJ, Hellard ME. Treatment of hepatitis C virus infection among people who are actively injecting drugs: a systematic review and meta-analysis. Clin Infect Dis. 2013 Aug;57 Suppl 2:S80-9. doi: 10.1093/cid/cit306.
Results Reference
result
PubMed Identifier
16183464
Citation
Sylvestre DL, Litwin AH, Clements BJ, Gourevitch MN. The impact of barriers to hepatitis C virus treatment in recovering heroin users maintained on methadone. J Subst Abuse Treat. 2005 Oct;29(3):159-65. doi: 10.1016/j.jsat.2005.06.002.
Results Reference
result
PubMed Identifier
20425880
Citation
Grebely J, Knight E, Genoway KA, Viljoen M, Khara M, Elliott D, Gallagher L, Storms M, Raffa JD, DeVlaming S, Duncan F, Conway B. Optimizing assessment and treatment for hepatitis C virus infection in illicit drug users: a novel model incorporating multidisciplinary care and peer support. Eur J Gastroenterol Hepatol. 2010 Mar;22(3):270-7. doi: 10.1097/meg.0b013e32832a8c4c.
Results Reference
result
PubMed Identifier
23616960
Citation
Newman AI, Beckstead S, Beking D, Finch S, Knorr T, Lynch C, MacKenzie M, Mayer D, Melles B, Shore R. Treatment of chronic hepatitis C infection among current and former injection drug users within a multidisciplinary treatment model at a community health centre. Can J Gastroenterol. 2013 Apr;27(4):217-23. doi: 10.1155/2013/515636.
Results Reference
result
PubMed Identifier
26005037
Citation
Mason K, Dodd Z, Sockalingam S, Altenberg J, Meaney C, Millson P, Powis J. Beyond viral response: A prospective evaluation of a community-based, multi-disciplinary, peer-driven model of HCV treatment and support. Int J Drug Policy. 2015 Oct;26(10):1007-13. doi: 10.1016/j.drugpo.2015.04.012. Epub 2015 Apr 29.
Results Reference
result

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

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