Elana Rosenthal

Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial

Background 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. Objective To determine the efficacy of HCV treatment independently provided by nurse practitioners (NPs), primary care physicians (PCPs), or specialist physicians using DAA therapy. Design Nonrandomized, open-label clinical trial initiated in 2015. (ClinicalTrials.gov: NCT02339038). Setting 13 urban, federally qualified health centers (FQHCs) in the District of Columbia. Patients 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. Intervention 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. Measurements Sustained virologic response (SVR). Results 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. Limitation Nonrandomized patient distribution; possible referral bias. Conclusion 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. Primary Funding Source National Institutes of Health and Gilead Sciences.

HIV/HCV Co-infection: Overcoming Barriers to Treatment

A critical step in the eradication of hepatitis C virus (HCV) infection is access to effective therapy. With the advent of interferon‐free regimens, HCV providers and patients gained hope that the success seen in clinical trials could be translated to the real world. However, the exorbitant cost of the new direct‐acting antivirals limits access to these medications to the general HCV population, especially underserved patients with public insurance. We used a descriptive qualitative approach to detail the measures necessary and challenges faced by an inner‐city nursing team in Washington, DC to obtain the new direct‐acting antivirals. Significant time and dedication on the part of providers and staff was required to assist patients with the process of obtaining direct‐acting antivirals.

Clinical Laboratory Testing in the Era of Directly Acting Antiviral Therapies for Hepatitis C

SUMMARY Directly acting antiviral (DAA) combination therapies for chronic hepatitis C virus (HCV) infection are highly effective, but treatment decisions remain complex. Laboratory testing is important to evaluate a range of viral, host, and pharmacological factors when considering HCV treatment, and patients must be monitored during and after therapy for safety and to assess the viral response. In this review, we discuss the laboratory tests relevant for the treatment of HCV infection in the era of DAA therapy, grouped according to viral and host factors.

A Practical Approach and Model of Care for HCV Treatment With Direct Acting Antivirals in an Urban Setting

Elizabeth Akoth, RN, BSN, MSN, is a Research Lead Specialist, Institute of Human Virology, University of Maryland School of Medicine Baltimore, Maryland, USA, and a Special Volunteer, National Institutes of Health, Bethesda, Maryland, USA. (*Correspondence to: elizabeth.akoth@nih.gov). Chloe Gross, RN, BSN, ACRN, is a Research Lead Specialist, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland, USA, and a Special Volunteer, National Institutes of Health, Bethesda, Maryland, USA. Rachel Silk, RN, BSN, MPH, is a Clinical Nurse Administrator, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland, USA, and a Special Volunteer, National Institutes of Health, Bethesda, Maryland, USA. Elana Rosenthal, MD, is an Assistant Professor, Institute of Human Virology Division of Infectious Diseases, University of Maryland School of Medicine, Baltimore, Maryland USA, and a Special Volunteer, National Institutes of Health, Bethesda, Maryland, USA. Sarah Kattakuzhy, MD, is an Assistant Professor, Institute of Human Virology Division of Infectious Diseases University of Maryland School of Medicine Baltimore, Maryland, USA, and a Special Volunteer, National Institutes of Health, Bethesda, Maryland, USA. The U.S. Food and Drug Administration’s (FDA) approval of highly efficacious and tolerable directacting antivirals (DAAs) has led to a cure for hepatitis C virus (HCV) in many patients. The American Association for the Study of Liver Diseases (AASLD) and Infectious Disease Society of America (IDSA) guidelines recommended HCV treatment for all patients with chronic HCV regardless of disease stage (AASLD and IDSA, 2016). In contrast, a summary report by the Center for Evidence-Based Policy (2016) showed that many state Medicaid plans restricted treatment to patients with Stage 2 or higher liver disease. In the general population, barriers such as the high cost of DAAs, insurance restrictions, and lack of provider availability have left many without treatment (IDSA and AASLD, 2016). Despite the availability of DAAs, the uptake of these medications has remained low, even in health systems such as the U.S. Veterans Administration, where there were no restrictions to medication acquisition. The Veterans Administration reported that, as of 2013, approximately 174,000 veterans had been diagnosed with HCV infection, but at least 124,000 veterans had yet to be treated (Moon, Green, Berry, & Ioannou, 2016). The District of Columbia (DC) continues to be disproportionately affected by HIV and HCV. As of December 2015, at least 13,391 DC residents were living with HIV, roughly 2% of the Washington, DC,