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 the 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.
Brief Title
Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Hepatitis C
Medication Adherence
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03127358
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2016-7215
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Smartphone Based Automated-Directly Observed Treatment Improves Adherence and SVR to Fixed-Dose Elbasvir and Grazoprevir in PWIDs: A Randomized Control Trial
Primary Outcomes
Outcome Description
The amount of medication taken by each patient during the treatment period is expressed as a percentage (range 0-100%). Subjects will be classified as "adherent" if they receive at least 80% of the total dose of Zepatier. The numbers below denotes the mean percent of the medication the participants in each arm took.
Outcome Measure
HCV Treatment Adherence
Outcome Time Frame
12 weeks
Secondary Outcomes
Outcome Description
Participants will be considered to have completed treatment if they have completed at least 80% of the planned treatment course (e.g. at least 10 week of 12-week course).
Outcome Time Frame
12 weeks
Outcome Measure
Number of Participants With HCV Treatment Completion
Outcome Description
HCV viral load undectable 12 weeks after treatment completion. Undetectable HCV viral load is defined as \<15 IU/ml and "target not detected". IU refers to "international units".One of the main outcomes looked for was the amount of patients who achieved Sustained Virologic Response (SVR) at 12 weeks post treatment, which denotes a cure of Hepatitis C.
Outcome Time Frame
12 weeks post treatment
Outcome Measure
Number of Participants With Sustained Viral Response (SVR)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Julia Arnsten
Investigator Email
julia.arnsten@einsteinmed.org
Investigator Phone
718-920-6641
Categories Mesh Debug
Hepatitis --- HEPATITIS C
Substance Use and Addiction --- BEHAVIOR, ADDICTIVE
Hepatitis --- HEPATITIS C, CHRONIC
Digestive System --- LIVER DISEASES
Liver --- LIVER DISEASES
Blood Disorders --- BLOOD-BORNE INFECTIONS
HIV/AIDS --- BLOOD-BORNE INFECTIONS
Infectious Disease --- BLOOD-BORNE INFECTIONS
Hepatitis --- COMMUNICABLE DISEASES
HIV/AIDS --- COMMUNICABLE DISEASES
Infectious Disease --- COMMUNICABLE DISEASES
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
Hepatitis --- HEPATITIS, VIRAL, HUMAN
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
COVID-19 --- RNA VIRUS INFECTIONS
Infectious Disease --- RNA VIRUS INFECTIONS
Hepatitis --- HEPATITIS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Substance Use and Addiction --- COMPULSIVE BEHAVIOR
Substance Use and Addiction --- IMPULSIVE BEHAVIOR
Hepatitis --- HEPATITIS, CHRONIC
MeSH Terms
HEPATITIS C
MEDICATION ADHERENCE
BEHAVIOR, ADDICTIVE
HEPATITIS C, CHRONIC
DIRECTLY OBSERVED THERAPY
REINFECTION
LIVER DISEASES
BLOOD-BORNE INFECTIONS
COMMUNICABLE DISEASES
INFECTIONS
HEPATITIS, VIRAL, HUMAN
VIRUS DISEASES
FLAVIVIRIDAE INFECTIONS
RNA VIRUS INFECTIONS
HEPATITIS
DIGESTIVE SYSTEM DISEASES
PATIENT COMPLIANCE
PATIENT ACCEPTANCE OF HEALTH CARE
TREATMENT ADHERENCE AND COMPLIANCE
HEALTH BEHAVIOR
BEHAVIOR
COMPULSIVE BEHAVIOR
IMPULSIVE BEHAVIOR
HEPATITIS, CHRONIC
CHRONIC DISEASE
DISEASE ATTRIBUTES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
RECURRENCE