The 18th peer-reviewed journal article utilizing our adherence platform was recently published in The Lancet. The study, which took six years and included over 750 patients with Chronic Hepatitis C (HCV), found that people who inject drugs (PWID) can reach high sustained virological response (SVR) or “cure” in diverse settings with the Scene’s Video Directly Observed Therapy (DOT) platform.
HCV is a serious health condition that affects the liver, and can lead to organ failure and death. Fortunately, new treatments called direct-acting antivirals (DAAs) are highly effective and can cure most cases, making the goal of HCV elimination achievable. HCV infection is more prevalent in PWID making them a population of key focus for treatment. But for active drug users, access to HCV treatment may be restricted over concerns about adherence and reinfection.
As key care settings for PWIDs, opioid treatment programs (OTPs) and community health centers (CHCs) are uniquely positioned to effectively promote HCV treatment and ensure medication adherence as part of ongoing substance use disorder treatment, but they need innovative and effective care models to ensure this very vulnerable population will be successful in treatment.
The Hepatitis C Real Options study (HERO study) compared two care models - modified directly observed therapy (mDOT) and patient navigation (PN) - to achieve HCV treatment initiation, adherence, completion, and SVR among PWID. Principal Investigator Dr. Alain Litwin and the HERO study team conducted a pragmatic randomized controlled trial across eight U.S. cities and 23 sites.
Over 750 patients were given a fixed-dose taken orally once a day for 12 weeks, and randomly assigned to either mDOT or patient navigation. The mDOT intervention included both in-person DOT and video DOT monitoring strategies. Scene Health (formerly known as emocha Health) partnered with the HERO study to provide access to our video DOT mobile applications and mobile devices to patients receiving care at CHCs, where in-person DOT services were not already available. The PN intervention involved on-site patient navigators to help patients coordinate HCV treatment and promote adherence among other activities.
Patients in the mDOT and PN groups enrolled to the study, initiated treatment, and completed treatment at comparable rates. Overall treatment adherence was high (mDOT - 78.0; PN - 73.4%) in both care models, but 4.7% higher in the mDOT group, and to a statistically significant degree, compared with the PN group. Adherence was highest in OTPs among patients assigned mDOT (83.7%) and 8.4% higher than PN. Both intervention groups achieved comparably high rates of SVR (mDOT - 74%; PN - 76%) demonstrating that both models are effective at helping patients achieve cure.
The results are even more compelling when considering that the study population was affected by high rates of depression (approx. 50%), low rates of employment (approx. 35%), severe housing instability (approx. 42%), and unstable transportation options (approx. 60%). Social Determinants of Health (SDOH) such as these play a large factor in medication nonadherence.
This study demonstrates that PWIDs can benefit from DAAs through mDOT or patient navigation interventions as HCV treatment models to achieve high rates of adherence and SVR. HCV elimination efforts can confidently expand and integrate these models to promote access to HCV treatment for this important population.
Dr. Alain Litwin is a Professor at Clemson University School of Health Research and the Vice Chair for Academics in the Department of Medicine for Prisma Health–Upstate.