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Intensive Models of HCV Care for Injection Drug Users

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ClinicalTrials.gov Identifier: NCT01857245
Recruitment Status : Active, not recruiting
First Posted : May 20, 2013
Last Update Posted : June 18, 2018
Sponsor:
Collaborators:
Clemson University
Albert Einstein College of Medicine, Inc.
Information provided by (Responsible Party):
Alain Litwin, Greenville Health System

Brief Summary:

Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associated with increased survival. However, IDUs have had poor access to HCV care and their success in HCV treatment has been limited. With direct-acting antiviral agents, HCV treatment delivered within large clinical trials leads to SVR or cure in over 70% of genotype-1 infected patients, compared to 45% with previous therapies. However, SVR rates are as low as 14% in real-world settings. The majority of patients who fail to achieve SVR will develop drug resistance, but the optimal adherence level to minimize resistance is unknown. If HCV treatment continues to be delivered within current models of care, most IDUs will not only fail treatment and develop resistance, but may transmit resistant viruses to others. We have previously developed a multidisciplinary model of HCV care which integrates on-site primary care, substance abuse treatment, psychiatric care, and HCV-related care within opiate agonist treatment clinics. To maximize treatment outcomes, we piloted two models of intensive HCV-related care: directly observed therapy (DOT), and concurrent group therapy (CGT). In our DOT model, pegylated interferon is administered once weekly, if applicable, and one daily dose of oral medication is administered at the methadone window. In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides powerful social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections, if applicable. It is unknown whether either model is better or more cost-effective than standard on-site care.

PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing drug resistance; (2) To determine the incidence and factors associated with the development of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs.

PREVAIL 2: In the proposed study, 60 IDUs with chronic HCV (genotypes 1 2, 3 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and (2) to determine adherence rates over time in drug users (genotype 3 and genotype 1 / IFN-ineligible) initiating a 24 week IFN-free regimen.

PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine adherence rates over time in drug users.


Condition or disease Intervention/treatment Phase
Hepatitis C Medication Adherence Other: Intensive Models (mDOT and CGT) of HCV Care Not Applicable

Detailed Description:

PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing drug resistance; (2) To determine the incidence and factors associated with the development of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs.

PREVAIL 2: In the proposed study, 60 IDUs with chronic HCV (genotypes 1 2, 3 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and (2) to determine adherence rates over time in drug users (genotype 3 and genotype 1 / IFN-ineligible) initiating a 24 week IFN-free regimen.

PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine adherence rates over time in drug users.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Models of HCV Care for Injection Drug Users
Study Start Date : July 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Modified Directly Observed Therapy (mDOT)
In our mDOT model, pegylated interferon is administered once weekly, and one daily dose of oral medication is administered at the methadone window.
Other: Intensive Models (mDOT and CGT) of HCV Care
Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.

Experimental: Concurrent Group Treatment (CGT)
In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections.
Other: Intensive Models (mDOT and CGT) of HCV Care
Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.

Active Comparator: Treatment as Usual
In the TAU arm, subjects will receive all medications monthly (or more often as needed) at the clinic.
Other: Intensive Models (mDOT and CGT) of HCV Care
Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.




Primary Outcome Measures :
  1. Electronically monitored medication adherence [ Time Frame: 12-24 weeks ]
    Hepatitis C medication adherence will be measured using electronic blister pack monitoring.


Secondary Outcome Measures :
  1. Hepatitis C viral load. [ Time Frame: 12 weeks after treatment completion ]

Other Outcome Measures:
  1. Hepatitis C resistance [ Time Frame: Up to 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both

PREVAIL 1:

Inclusion Criteria:

  • HCV-infected, Genotype-1
  • Treatment naïve or treatment experienced patients
  • Willing to receive HCV treatment on-site
  • Initiating treatment with direct-acting antiviral agents (DAA) with or without ribavirin +/- pegylated interferon alfa-2a
  • Receiving methadone or buprenorphine in clinic at least one time per week
  • Age 18 or older
  • Able to provide informed consent
  • Psychiatrically stable
  • English or Spanish speaking
  • Currently enrolled in a methadone or buprenorphine treatment program in the designated clinics in the Bronx (Melrose, Port Morris, Waters Place)

Exclusion Criteria:

  • Known hypersensitivity (allergy) to interferon, ribavirin or DAA
  • Psychiatrically unstable
  • Pregnant or breast-feeding

PREVAIL 2:

Inclusion Criteria:

  • HCV-infected, Genotype-1, , 2, 3, or 4
  • Willing to receive HCV treatment on-site at an opiate agonist treatment program.
  • Initiating treatment with sofosbuvir and ribavirin +/- pegylated interferon alfa-2a
  • Age 18 or older
  • Able to provide informed consent
  • English or Spanish speaking
  • Currently a patient in one of the designated clinics in the Bronx (Melrose, Port Morris, Waters Place)

Exclusion Criteria:

  • Known hypersensitivity (allergy) to interferon, ribavirin or sofosbuvir
  • Pregnant or breast-feeding

PREVAIL 3:

Inclusion Criteria:

  • HCV-infected, Genotype-1 or 4
  • Willing to receive HCV treatment on-site at an opiate agonist treatment program.
  • Initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir.
  • Age 18 or older
  • Able to provide informed consent
  • English or Spanish speaking
  • Currently a patient in one of the designated clinics in the Bronx (Melrose, Port Morris, Waters Place)

Exclusion Criteria:

  • Known hypersensitivity (allergy) to sofosbuvir, simprevir or ledipasvir.
  • Pregnant or breast-feeding

PREVAIL 4

Inclusion Criteria:

  • HCV-infected, Genotype-1
  • Treatment naïve or treatment experienced patients
  • Willing to receive HCV treatment on-site
  • Initiating treatment with direct-acting antiviral agents (DAA) with or without ribavirin +/- pegylated interferon alfa-2a
  • Age 18 or older
  • Able to provide informed consent
  • Psychiatrically stable
  • English or Spanish speaking

Exclusion Criteria:

  • Known hypersensitivity (allergy) to interferon, ribavirin or DAA
  • Psychiatrically unstable
  • Pregnant or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857245


Locations
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Greenville Health System
Clemson University
Albert Einstein College of Medicine, Inc.
Investigators
Principal Investigator: Garland Gudger, MD, MPH Greenville Health System

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alain Litwin, Professor, Greenville Health System
ClinicalTrials.gov Identifier: NCT01857245     History of Changes
Other Study ID Numbers: 1R01DA034086-01, 2011-555
1R01DA034086-01 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Keywords provided by Alain Litwin, Greenville Health System:
addiction
Adherence (attribute)
Adverse effects
Agonist
Antiviral Agents
arm
base
care delivery
Caring
Chronic Hepatitis C
Clinic
Clinical Trials
Complex
Computer Simulation
cost
cost effective
cost effectiveness
Data
Development
Directly Observed Therapy
Disease
Dose
Drug resistance
drug resistant virus
Educational aspects
Epidemic
experience
Frequencies (time pattern)
Fright
Genotype

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents