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 (*)
Disclaimer: The content of this publication does not necessarily reflect the views or policies of the U.S. Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government.
Acknowledgment: The authors acknowledge the contributions of Jeff Binkley, Rob Taylor, and Thila Subramanian (Cerner data support); Steve Rader (Unity data support); Kenneth Rose, PhD, Esq. (technology transfer); Mary Hall (protocol support); Monica Thompson (HCV coordinator); Gwendolyn Sinclair, PharmD (medication distribution); and David Thomas, MD, MPH, and James Mikula, PharmD (provider training).
Grant Support: This project has been funded in whole or in part by the National Institutes of Health under contract HHSN269201400012C. Study medications and funding for the establishment of a database were provided by Gilead Sciences.
Disclosures: Dr. Kattakuzhy reports grants and nonfinancial support from Gilead Sciences during the conduct of the study. Ms. Gross reports grants from Gilead Sciences during the conduct of the study and is a shareholder in Merck, Pfizer, and Johnson & Johnson. Dr. Teferi reports grants and personal fees from Gilead Sciences outside the submitted work. Ms. Silk and Dr. Kottilil report grants from Gilead Sciences during the conduct of the study. Dr. Rosenthal reports grants and nonfinancial support from Gilead Sciences during the conduct of the study and grants and nonfinancial support from Gilead Sciences outside the submitted work. Dr. Wilson reports grants from Gilead Sciences outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-0118.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: See the Supplement. Statistical code: Available from Dr. Kottilil (e-mail, firstname.lastname@example.org). Data set: Not available.
Requests for Single Reprints: Shyam Kottilil, MD, PhD, Division of Clinical Care and Research, Institute of Human Virology, University of Maryland School of Medicine, Room S222, 725 West Lombard Street, Baltimore, MD 21201; e-mail, SKottilil@ihv.umaryland.edu.
Current Author Addresses: Drs. Kattakuzhy, Rosenthal, Tang, Wilson, and Kottilil, and Ms. Gross, Mr. Emmanuel, Ms. Silk, Ms. Akoth, Ms. Espinosa, and Ms. Price: Division of Clinical Care and Research, Institute of Human Virology, University of Maryland School of Medicine, Room S222, 725 West Lombard Street, Baltimore, MD 21201.
Dr. Teferi: Unity Health Care/Walker Jones, 40 Patterson Street, Northeast, Washington, DC 20002.
Dr. Jenkins: Family Medical Counseling Service Medical Clinic, 2041 Martin Luther King Jr. Avenue SE, Suite 300, Washington, DC 20020.
Dr. Bentzen: 600 West Redwood Street, Howard Hall 109D, Baltimore, MD 21201.
Ms. Thomas, Ms. Ahmed, and Dr. Masur: Building 10, Room 2C145, 10 Center Drive, Bethesda, MD 20814.
Author Contributions: Conception and design: S. Kattakuzhy, C. Gross, R. Silk, E. Akoth, H. Masur, S. Kottilil.
Analysis and interpretation of the data: S. Kattakuzhy, B. Emmanuel, S. Bentzen, H. Masur, S. Kottilil.
Drafting of the article: S. Kattakuzhy, B. Emmanuel, L. Tang, E. Wilson, S. Kottilil.
Critical revision for important intellectual content: S. Kattakuzhy, B. Emmanuel, E. Rosenthal, L. Tang, S. Bentzen, H. Masur, S. Kottilil.
Final approval of the article: S. Kattakuzhy, C. Gross, B. Emmanuel, G. Teferi, V. Jenkins, R. Silk, E. Akoth, A. Thomas, C. Ahmed, M. Espinosa, A. Price, E. Rosenthal, L. Tang, E. Wilson, S. Bentzen, H. Masur, S. Kottilil.
Provision of study materials or patients: S. Kattakuzhy, G. Teferi, V. Jenkins, A. Price, S. Kottilil.
Statistical expertise: B. Emmanuel, S. Bentzen, S. Kottilil.
Obtaining of funding: S. Kattakuzhy, H. Masur, S. Kottilil.
Administrative, technical, or logistic support: S. Kattakuzhy, G. Teferi, R. Silk, M. Espinosa, H. Masur, S. Kottilil.
Collection and assembly of data: S. Kattakuzhy, C. Gross, G. Teferi, R. Silk, E. Akoth, A. Thomas, C. Ahmed, A. Price, E. Rosenthal, S. Kottilil.
Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection has resulted in high rates of disease cure; however, not enough specialists currently are available to provide care.
To determine the efficacy of HCV treatment independently provided by nurse practitioners (NPs), primary care physicians (PCPs), or specialist physicians using DAA therapy.
Nonrandomized, open-label clinical trial initiated in 2015. (ClinicalTrials.gov: NCT02339038)
13 urban, federally qualified health centers (FQHCs) in the District of Columbia.
A referred sample of 600 patients, of whom 96% were black, 69% were male, 82% were treatment naive, and 20% had cirrhosis. Seventy-two percent of the patients had HCV genotype 1a infection. The baseline characteristics of patients seen by each provider type were similar.
Patients were assigned in a nonrandomized but specified manner to receive treatment from 1 of 5 NPs, 5 PCPs, or 6 specialists. All providers underwent an identical 3-hour training session based on guidelines. Patients received treatment with ledipasvir–sofosbuvir, which was provided on site, according to U.S. Food and Drug Administration labeling requirements.
Sustained virologic response (SVR).
516 patients achieved SVR, a response rate of 86% (95% CI, 83.0% to 88.7%), with no major safety signals. Response rates 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.
Nonrandomized patient distribution; possible referral bias.
In a real-world cohort of patients at urban FQHCs, HCV treatment administered by nonspecialist providers was as safe and effective as that provided by specialists. Nurse practitioners and PCPs with compact didactic training could substantially expand the availability of community-based providers to escalate HCV therapy, bridging existing gaps in the continuum of care for patients with HCV infection.
National Institutes of Health and Gilead Sciences.
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Kattakuzhy S, Gross C, Emmanuel B, Teferi G, Jenkins V, Silk R, et al. Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial. Ann Intern Med. [Epub ahead of print 8 August 2017]:. doi: 10.7326/M17-0118
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Published: Ann Intern Med. 2017.
Gastroenterology/Hepatology, Infectious Disease, Liver Disease, Viral Hepatitis.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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