Joseph Doyle, Paul Dietze, Mark Stoove, Peter Higgs, Paul Desmond, David Iser, Emma Mcbryde, Brendan Harney, Alisa Pedrana, Tim Spelman, Sally Von Bibra, Janine Roney, Alexander Thompson, Margaret Hellard
JOURNAL OF HEPATOLOGY 70, E495-E495; Community-based hepatitis C treatment of people who inject drugs and their injecting network is feasible and effective: Results from the TAP (Treatment And Prevention) study
Background and aims: People who inject drugs (PWID) are at risk of hepatitis C virus (HCV) infection and transmission of HCV within their injecting network. However, many barriers have limited engagement of PWID in specialist-led care. The HCV Treatment and Prevention (TAP) Study aimed to test the feasibility and effectiveness of treating PWID and their injecting partners concurrently in community settings using a nurse-led model of care.
Method: The TAP Study is a community-based trial using a networksbased approach to treatment (clinicaltrials.gov, NCT02363517). Eligible PWID were those with chronic HCV mono-infection, who injected drugs in the same time and place with ≥ 1 person in the previous six months. Participants were randomised to receive sofosbuvir/velpatasvir treatment individually, or concurrently with their HCV-infected injecting partners. Participants were recruited via mobile street-based vans or primary health clinics. Nurses performed study assessments including FibroScan and venepuncture, and delivered treatment from the mobile clinic after case discussion with clinical investigators. We report pooled SVR12+ (co-primary outcome) and treatment uptake. Follow-up to 72 weeks post-treatment for reinfection incidence by randomised group (co-primary outcome) is ongoing.
Results: The TAP Study screened 336 PWID and enrolled 241 participants; 114 primary participants with 127 injecting partners. Median age of participants was 39 years (range 20-59 years), most were male (167, 69%), unemployed (189, 78%), had previously been incarcerated (144, 60%), and 22% (52) reported unstable housing. Treatment was commenced in 93 (85%) primary participants and 37 (55%) viraemic injecting partners; prior incarceration was associated with failing to enroll or start treatment. There were no study or drug related serious adverse events. In per-protocol analysis, among 130 participants who started treatment, 114 had HCV RNA measured at or after SVR12, and 96 (84%) achieved SVR12+. There were six known relapses, two non-responders, three unspecified treatment failures and 10 confirmed reinfections. During 98 person years of follow-up to date, reinfection incidence is 10.2/100 person years. In modified intention to treat analysis, 74% achieved SVR12+, mostly due to failure to attend for assessment.
Conclusion: Nurse-led HCV treatment for active PWID is feasible and effective for community-based active PWID. Recruiting and treating injecting partners is challenging but is potentially an important model to interrupt HCV transmission-longer follow-up is needed before assessing the randomised impact of treatment on reinfection.