• Sarah Kattakuzhy, Chloe Gross, Benjamin Emmanuel, Gebeyehu Teferi, Veronica Jenkins, Rachel Silk, Elizabeth Akoth, Aurielle Thomas, Charisse Ahmed, Michelle Espinosa, Angie Price, Elana Rosenthal, Lydia Tang, Eleanor Wilson, Soren Bentzen, Henry Masur, Shyam Kottilil, and ASCEND Providers.
• From University of Maryland School of Medicine, Baltimore, Maryland; Unity Health Care and Family and Medical Counseling Services, Washington, DC; and National Institutes of Health, Bethesda, Maryland.
• Ann. Intern. Med. 2017 Sep 5; 167 (5): 311318311-318.

BackgroundDirect-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.ObjectiveTo determine the efficacy of HCV treatment independently provided by nurse practitioners (NPs), primary care physicians (PCPs), or specialist physicians using DAA therapy.DesignNonrandomized, open-label clinical trial initiated in 2015. (ClinicalTrials.gov: NCT02339038).Setting13 urban, federally qualified health centers (FQHCs) in the District of Columbia.PatientsA 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.InterventionPatients 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.MeasurementsSustained virologic response (SVR).Results516 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.LimitationNonrandomized patient distribution; possible referral bias.ConclusionIn 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.Primary Funding SourceNational Institutes of Health and Gilead Sciences.

28 keywords...

hide…