Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03127358 |
| Other study ID # |
2016-7215 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 14, 2017 |
| Est. completion date |
February 6, 2019 |
Study information
| Verified date |
August 2021 |
| Source |
Albert Einstein College of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
