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

NCT03093415 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: CRS00002743
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis C; Substance Use Disorders; Substance Abuse, Intravenous

Keywords

Hepatitis C; HCV; People Who Inject Drugs; PWID; Medication Assisted Therapy; MAT; Needle Exchange Program

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks post-initiation of treatment (12 weeks post-completion of treatment)

Secondary Outcomes (5)

• SVR 48

  60 weeks post-initiation of treatment (48 weeks post-completion of treatment)

• Discontinuation Rate or Lost To Follow Up

  Study duration (60 weeks)

• NS5A Resistance

  At Study Screening/Enrollment

• Medication Adherence

  12 weeks (duration of treatment)

• Injection Drug Use Relapse (IDU)

  Duration of study (60 weeks)

Study Arms (3)

Old Town Clinic, Medication Assisted Therapy group

ACTIVE COMPARATOR

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)

Outside In Clinic, Needle Exchange Program

ACTIVE COMPARATOR

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)

OHSU Hepatology Clinic, Academic center Retrospective Cohort

OTHER

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)

Interventions

elbasvir-grazoprevir (50 mg/100 mg) DRUG

12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)

Also known as: Zepatier

OHSU Hepatology Clinic, Academic center Retrospective Cohort; Old Town Clinic, Medication Assisted Therapy group; Outside In Clinic, Needle Exchange Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (2)

Old Town Clinic

Portland, Oregon, 97214, United States

Location

Outside In

Portland, Oregon, 97214, United States

Location

Related Publications (7)

• 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.

  PMID: 22938915 BACKGROUND

• 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.

  PMID: 23884067 RESULT

• 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.

  PMID: 23884071 RESULT

• 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.

  PMID: 16183464 RESULT

• 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.

  PMID: 20425880 RESULT

• 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.

  PMID: 23616960 RESULT

• 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.

  PMID: 26005037 RESULT

MeSH Terms

Conditions

Hepatitis C; Substance-Related Disorders; Substance Abuse, Intravenous

Interventions

elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Study groups comparisons of sites of enrollment/treatment (MAT clinic vs needle exchange) rather than disease state (many MAT participants used needle exchange; many needle exchange on MAT); funding limitations prevented SVR48 collection.

Results Point of Contact

• Title: Andrew Seaman, MD
• Organization: Oregon Health and Sciences University

seaman@ohsu.edu

1 (971) 271 - 6102

Study Officials

• Atif Zaman, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 28, 2017
• Study Start: May 30, 2017
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: November 12, 2020
• Results First Posted: November 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)