Hepatitis C Treatment in PWIDs: MAT or Syringe Exchange Assisted-therapy vs Standard of Care
NCT ID: NCT03093415
Last Updated: 2020-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2017-05-30
2019-06-06
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
elbasvir-grazoprevir (50 mg/100 mg)
12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
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.
elbasvir-grazoprevir (50 mg/100 mg)
12 week treatment of 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 (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks.
elbasvir-grazoprevir (50 mg/100 mg)
12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Interventions
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elbasvir-grazoprevir (50 mg/100 mg)
12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Andrew Seaman
Co Investigator
Principal Investigators
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Atif Zaman, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Old Town Clinic
Portland, Oregon, United States
Outside In
Portland, Oregon, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CRS00002743
Identifier Type: -
Identifier Source: org_study_id