Comparison of direct-acting antiviral therapy for hepatitis C between specialist centers and primary care: Efficacy and adherence to response assessment.

Introduction: With the availability of direct-acting antiviral (DAA) therapy in primary care, Australia is in a unique position to eradicate chronic hepatitis C (CHC). Success of this initiative is dependent on uptake and monitoring of efficacy (sustained virological response at 12 weeks [SVR12]). The treatment of CHC has previously been protocol-based and required significant resources and careful patient selection to optimize adherence. Treatment in primary care will remove many of these barriers; however, the effect on adherence to treatment and follow-up is unknown. We aim to study the adherence to DAA treatment protocols and assess outcomes in primary and tertiary care settings. Method(s): Participants with CHC were prospectively recruited between October 2014 and November 2016 from 12 primary care practices and compared with patients prospectively recruited and managed solely at specialist centers. All patients underwent clinical, biochemical, virological, and liver stiffness measurement (LSM) assessment. Individuals initially assessed in primary care with an LSM >= 12.5 kPa or dual infection were referred to specialist centers. DAA efficacy and adherence to SVR12 testing were monitored in both the primary and specialist centers. Follow-up was censored on 1 April 2017. Result(s): Overall, there were 1044 participants with CHC recruited. DAA therapy was commenced in 503: 40.6% in primary care (n = 204) and 59.4% in specialist centers (n = 299). At time of analysis, 337 patients had reached their SVR12 date, but only 75% (n = 253) had completed SVR12 polymerase chain reaction testing. In patients with SVR12 data available, cure rates were equivalent between tertiary center and primary care treatment groups (96.2% vs 97.3%, P = 0.668). Treatment failures were seen in genotype 1a and 3 with equal frequency (1.1% vs 1.3%, P = 1.00). LSM >= 12.5 kPA was not associated with treatment failure (5.5% vs 2.9%, P = 0.406). Participants commenced on DAA therapy at tertiary