Clinical trial NCT03127358: Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs
Official title: Smartphone Based Automated-Directly Observed Treatment Improves Adherence and SVR to Fixed-Dose Elbasvir and Grazoprevir in PWIDs: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Medication Adherence
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
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: AiCure
name: Merck Sharp & Dohme LLC
First posted: 2017-04-25
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: HCV Treatment Adherence
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Participants With HCV Treatment Completion
timeFrame: 12 weeks
measure: Number of Participants With Sustained Viral Response (SVR)
timeFrame: 12 weeks post treatment
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine Division of Substance Abuse clinics
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Julia Arnsten, MD
role: PRINCIPAL_INVESTIGATOR
References: