Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers

Abstract

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.

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

“…One approach to improving access to curative HCV treatment is expanding the number of health care providers administering antiviral therapy. Data demonstrate that HCV treatment can be effectively provided by a broad range of health care professionals with differing expertise—including specialists, primary care physicians, nurse practitioners, clinical pharmacy specialists, physician assistants, and registered nurses—without compromising treatment efficacy or safety . Consequently, the HCV guidance panel developed simplified HCV treatment algorithms for treatment‐naive adults (without cirrhosis or with compensated cirrhosis), which align with the NASEM plan to eliminate HCV as a US public health burden by 2030.…”

The management of chronic hepatitis C: 2018 guideline update from the Canadian Association for the Study of the Liver

“…A focused literature search for both published and unpublished literature was undertaken to update the evidence base used in the 2015 guideline. In brief, the litera ture search was conducted in MEDLINE (Jan. 15,2015 to Oct. 31,2016), using the following search terms: hepatitis C, hepatitis and treatment. Englishlanguage articles were included.…”

“…29 Training primary care providers, addiction specialists, nurses and nurse practitioners to provide HCV care, as well as using telemedicine approaches (e.g., Project ECHO) to comanage patients, can lead to delivery of highquality HCV treatment with outcomes similar to those achieved in academic centres. 30,31 Expansion of nonspecialist HCV care will be required in Canada to ensure that all infected individuals receive appropriate care.…”

“…31 To reach all infected Canadians, expansion of the pool of those providing treatment will need to be a major priority, particularly among primary care providers for populations with a high burden of HCV, such as those born in countries with high prevalence of HCV infection, Indigenous populations and those in addiction services, prisons and other highprevalence settings.…”

Clinical effectiveness, cost effectiveness and acceptability of community‐based treatment of hepatitis C virus infection: A mixed method systematic review

“…The other criteria (standard criteria for measuring the condition, valid and reliable way for measuring the outcomes and appropriate statistical analysis) were met by all studies. Sixteen studies fulfilled all the eight criteria …”