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Completed

NCT Number: NCT01857245

Intensive Models of HCV Care for Injection Drug Users

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.

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Key information

Conditions

Hepatitis C Behavior Behavior, Addictive Blood-Borne Infections Chronic Disease Communicable Diseases Compulsive Behavior Digestive System Diseases Directly Observed Therapy Disease Disease Attributes Flaviviridae Infections Health Behavior Hepatic Insufficiency Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Impulsive Behavior Infections Liver Diseases Liver Failure Medication Adherence Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Treatment Adherence and Compliance Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Greenville Health System

Greenville, South Carolina, 29605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive Models (mDOT and CGT) of HCV Care

Other

Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.

Primary outcomes

  1. Electronically Monitored Medication Adherence

    Time frame: 1-12 weeks

    Hepatitis C medication adherence will be measured using electronic blister pack monitoring.

Secondary outcomes

  1. Sustained Virologic Response

    Time frame: 12 weeks after treatment completion

    Undetectable HCV RNA at posttreatment week 12.

  2. HCV Treatment Completion

    Time frame: Up to 48 weeks

    Completion of ≥80% of the planned treatment course. For example, ≥10 wk of a 12-wk course, or ≥20 wk of a 24-wk course.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Albert Einstein College of Medicine
  • Clemson University

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 20, 2013
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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