MedicalResearch.com Interview with:
Sarah Kattakuzhy, MD
Clinical and Administrative Director, DC PFAP Hepatitis Clinical Research Program
Assistant Professor, Institute of Human Virology
Division of Infectious Diseases
University of Maryland
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The recent introduction of highly effective, well-tolerated direct-acting antiviral (DAA) therapy for hepatitis C virus infection has raised the possibility of rapid treatment expansion and widespread cure. However, the current specialist workforce is insufficient to meet the treatment demands of the 2.7 million Americans living with HCV infection. Several studies of partial task shifting—shared treatment between specialists and primary care providers—have demonstrated success in improving access to HCV care. Yet, information on the success of nonspecialists practicing independent of specialist supervision is limited.
The primary objective of ASCEND was to evaluate the efficacy of Hepatitis C treatment managed independently by 3 community-based provider types—nurse practitioners (NPs), PCPs, and specialists—after a succinct, guideline-driven educational intervention, set within a real-world, urban population.
In this investigation, 516 out of 600 patients achieved SVR, a response rate of 86% (95% CI, 83.0% to 88.7%), with no major safety signals. Rates of SVR were consistent across the 3 provider types—NPs: 89.3% (CI, 83.3% to 93.8%); PCPs: 86.9% (CI, 80.6% to 91.7%); and specialists: 83.8% (CI, 79.0% to 87.8%). Patient loss to follow-up was the major cause of non-SVR.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: The results of the ASCEND investigation suggest that in the DAA era, nonspecialist providers can be trained rapidly to offer a single-step “diagnosis–linkage–treatment” continuum, avoiding the need for referrals in uncomplicated cases. The study demonstrates that current insurance-based provider restrictions are not supported by evidence and stand as unnecessary hurdles in the Hepatitis C care continuum. Reversal of such policies might allow rapid escalation of safe, effective therapy for HCV infection and improve the care of patients living with this potentially fatal disease.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Future research should focus on the impact of policy change on uptake of treatment and cure of chronic hepatitis C, and on the long term healthcare impact of widespread HCV cure.
Disclosures: The study was supported in part by the National Institutes of Health and an investigator initiated study grant from Gilead Sciences.
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Sarah Kattakuzhy, MD; Chloe Gross, RN; Benjamin Emmanuel, MPH; Gebeyehu Teferi, MD; Veronica Jenkins, MD; Rachel Silk, RN, MPH; Elizabeth Akoth, RN, MS; Aurielle Thomas, BA; Charisse Ahmed, BS; Michelle Espinosa; Angie Price, CRNP; Elana Rosenthal, MD; Lydia Tang, MD; Eleanor Wilson, MD, MS; Soren Bentzen, PhD; Henry Masur, MD; Shyam Kottilil, MD, PhD; and the ASCEND Providers (*)
Published: Ann Intern Med. 2017.
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