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Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs

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ClinicalTrials.gov Identifier: NCT03127358
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : January 2, 2018
Sponsor:
Collaborators:
AiCure
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Julia H. Arnsten, Albert Einstein College of Medicine

Brief Summary:
People who Inject Drugs (PWIDs) constitute 60% of the approximately 5 million people in the United States infected with hepatitis C virus (HCV). Successful HCV treatment leading to sustained viral response (SVR) is associated with increased survival, but to date successful treatment of PWIDs has been limited. Treatment of PWIDs is complex due to addiction, mental illness, poverty, homelessness, lack of positive social support, poor adherence-related skills, low motivation and knowledge, and poor access to and trust in the health care system. At Albert Einstein College of Medicine, the investigators have developed a multidisciplinary model of HCV care that integrates on-site primary care, substance abuse treatment, and HCV-related care within opiate agonist treatment clinics. To optimize HCV treatment outcomes, the investigators have introduced directly observed therapy (DOT). In our DOT model, one daily dose of oral HCV medication is administered with methadone. However, DOT is not feasible for PWIDs who are not enrolled in methadone maintenance treatment programs, and is less effective for methadone-maintained PWIDs who do not attend the methadone clinics every day. In addition, DOT has been used for decades both to measure and maximize adherence for treatment of tuberculosis infection, but the cost and logistical complexity of administering DOT for large HCV clinical programs would be prohibitive.

Condition or disease Intervention/treatment Phase
Hepatitis C Medication Adherence Behavioral: Automated Directly Observed Therapy Behavioral: Control, TAU Not Applicable

Detailed Description:

Automated DOT (a-DOT), a smartphone app that uses facial recognition software and advanced features to detect non-ingestion, combines the accuracy of in-person DOT with the convenience of real-time centralized data collection and monitoring. Adding a daily side effect diary to a-DOT will further allow precise tracking of timing of both medication ingestion and side effects which may be compromising adherence. Zepatier (elbasvir and grazoprevir) is a new once-daily fixe-dose combination tablet which has achieved high rates of SVR ranging from 94 to 97 percent in genotype-1 infected patients including those with HIV/HCV coinfection and renal impairment. Zepatier is administered for 12 to 16 weeks, depending on HCV genotype, prior treatment history, and the presence of certain baseline NS5A polymorphisms (1a only). By administering Zepatier via this innovative a-DOT platform, the investigators hypothesize that PWIDs treated in real-wrold settings can be successfully treated with high rates of adherence and SVR.

In this proposed 18-month trials, 75 PWIDs enrolled in opiate agonist treatment (genotypes 1a and 1b) with chronic HCV will be enrolled over a 12-month period, and randomized to either aDOT or treatment as usual (TAU). The investigators will recruit PWIDs from diverse community settings include a syringe exchange program (NYHRE), federally-qualified health center (Comprehensive Health Care Center), homeless shelter (The Living Room), and a methadone maintenance treatment program (Montefiore Wellness Centers). All patients (inlcuding treatment-experienced and HIVV/HCV coinfected subjects) will be treated with Zepatier-based regimens as per the standard of care. Rigorous data are necessary to judge the contribution of a-DOT to the success of HCV treatment in PWIDs. By performing a randomized trial of a-DOT HCV therapy (Zepatier with and without ribavirin), the investigators will evaluate the efficacy of a-DOT for improving HCV treatment outcomes among PWIDs.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smartphone Based Automated-Directly Observed Treatment Improves Adherence and SVR to Fixed-Dose Elbasvir and Grazoprevir in PWIDs: A Randomized Control Trial
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : March 1, 2019

Arm Intervention/treatment
Active Comparator: Intervention
Participants will use a-DOT technology to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12-16 weeks.
Behavioral: Automated Directly Observed Therapy
Participants will be randomized to either a-DOT or TAU. Participants randomized to the a-DOT group will receive treatment for HCV with Elbasvir-Grazoprevir using a cellphone app to monitor adherence, w

Placebo Comparator: Control
Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12-16 weeks.
Behavioral: Control, TAU
Participants in the control group (TAU), will receive treatment for HCV with Elbasvir-Grazoprevir as per standard of care.




Primary Outcome Measures :
  1. Sustained Viral Response (SVR) [ Time Frame: 12 weeks after treatment completion ]
    HCV viral load undecetable 12 weeks after treatment completion


Secondary Outcome Measures :
  1. HCV Treatment Adherence [ Time Frame: 12-16 weeks ]
    Pill count



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCV-infected (HCV RNA test above the limit of quantification at baseline)
  • Genotypes/Subtypes: G1a or G1b
  • Eligible for HCV treatment per 2016 AASLD/IDSA guidelines
  • Willing to receive HCV treatment on-site at DoSA clinics
  • Health care provider decision to treat patient with Zepatier-based therapy with or without ribavirin based on 2016 AASLD/IDSA guidelines
  • Using illicit drugs (either opiates, cocaine, or benzodizepenes) within the last 6 months
  • Age 18 or older
  • Able to provide informed consent
  • English or Spanish speaking

Exclusion Criteria:

  • Known hypersensitivity (allergy) to elbasvir, grazoprevir, or ribavirin
  • 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): NCT03127358


Contacts
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Contact: Julia Arnsten, MD 718-920-6641 jarnsten@montefiore.org

Locations
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United States, New York
Albert Einstein College of Medicine Division of Substance Abuse clinics Recruiting
Bronx, New York, United States, 10461
Contact: Julia Arnsten, MD    718-944-3840    jarnsten@montefiore.org   
Principal Investigator: Julia Arnsten, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine
AiCure
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Julia Arnsten, MD Montefiore Medical Center

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Responsible Party: Julia H. Arnsten, Professor, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03127358     History of Changes
Other Study ID Numbers: 2016-7215
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified specimens and information will be kept for up to 50 years for future studies.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julia H. Arnsten, Albert Einstein College of Medicine:
Addiction
Sustained Viral Response
Adherence
Adverse Effects
Direct Acting Antiviral Agent
Chronic Hepatitis C
Resistance Development
Methadone Clinic
Primary Care
Directly Observed Therapy
Randomized Controlled Trial
Resistance
Reinfection
Treatment Outcome
Patient Navigation
Multi-Site
Liver Disease
Intervention
Additional relevant MeSH terms:
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MK-5172
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents