A Primary Care-based Collaborative Hepatitis C Clinic: Clinical Structure and Virologic Outcomes with Direct Acting Antiviral Therapy

Abstract

Background: Currently 4 million persons in the US have active hepatitis C infection and world- wide there may be as many as 170 million people with this infection. Most patients have never been treated and newer therapies herald the potential for wider uptake and acceptance of treatment. Primary care providers will be needed to help expand access to care, but few models of collaborative primary care hepatitis C practices exist. Methods: Retrospective analysis of collaborative primary care clinic for evaluation and treatment of patients with chronic hepatitis C at a single VA medical center. A single half-day clinic was organized with 4 primary care MDs, two nurse practitioners, one nurse case manager, and 1-2 hepatologists. A co-located psychiatrist and one pharmacist were integrated into the clinic, and bi-monthly noon meetings were held to discuss treatment issues. Clinic productivity and outcomes related to the number of patients who initiated and completed treatment with direct acting antivirals (DAA) and pegylated interferon and ribavirin from July 2011 through December 2012. Results: This clinic had 1890 confirmed HCV registry patients and a total of 1690 clinic visits during this 18 month time period. Clinic capacity included 215 patient slots per month. Same week appointment access was provided. During this time 74 patients with HCV genotype 1 initiated DAA antiviral therapy. Primary care providers treated 47 patients (32% cirrhotic) vs.27 patients treated by hepatologists (48% cirrhotic). The percentage of patients that completed 0-19 weeks, 20-28 weeks, 29-36 weeks, and greater than 36 weeks of antiviral treatment 25.9%, 36.2%, 10.3%, and 27.6, respectively. Final SVR rate was 46% (33.3% cirrhotics vs 55.2% noncirrhotics). SVR rates were higher in patients with primary care providers (60%) compared with hepatology providers (25%), likely due to the higher incidence of cirrhosis in the latter group. Early treatment termination due to adverse events occurred in 6.6%, and treatment termination for virologic non-response was observed in 21.6% patients. Conclusions: This primary care and mid-level providerbased clinic with co-located hepatologists and one psychiatrist demonstrated high patient volumes and access. DAA antiviral therapy administered by primary care providers achieved SVR rates of 60%, approaching published clinical trials. These data illustrate the potential for a collaborative clinic with effective state of the art therapies for patients with high prevalence of comorbidities. Similar models may be useful for expanding access to effective HCV care in other clinic and hospital settings.