Cross-posted from the Department of Health and Human Services' Viral Hepatitis Blog  

Summary: Study published in Annals of Internal Medicine found no differences in sustained virologic response among patients treated for HCV infection by specialists, primary care physicians, and nurse practitioners.

The introduction of direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection has resulted in a well-tolerated treatment regimen and high rates of cure that have brought the possibility of widespread treatment and cure for patients with chronic HCV infection even closer to reality. Unfortunately, with roughly 2.7 million Americans living with HCV infection and only about 20,000 specialists (gastroenterology-hepatology and infectious disease physicians) in the United States, the current specialist workforce is not large enough to treat all the people who will need it.

A recently published study looked at whether nonspecialist healthcare providers could help meet the treatment needs of Americans with HCV. This supports one of the goals of the National Viral Hepatitis Action Plan (NVHAP), which calls for building the capacity of the health care workforce to improve access to treatment for persons infected with HCV.

One approach to improving access to HCV care and treatment is task shifting, which involves the redistribution of work activities among various healthcare workers. This strategy- training non-specialists to practice independently of specialist supervision- can also help to make better use of health workforce resources overall. However, information on the success of this approach for viral hepatitis is limited.

To shed light on this issue, a clinical trial was conducted at 13 community health centers in Washington, D.C. The Phase IV pilot study to “Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection with HIV in the District of Columbia” (ASCEND Study) evaluated the effectiveness of HCV management and treatment by three types of providers – specialists, primary care physicians (PCPs), and nurse practitioners (NPs).

Six hundred patients with chronic HCV infection were enrolled to receive treatment with ledipasvir (LDV) and sofosbuvir (SOF) from 1 of the 3 provider types including 6 specialists, 5 PCPs, and 5 NPs. All received training prior to study initiation. The goal of the treatment was SVR- also known as a cure, defined as an undetectable HCV RNA viral load 12 weeks after the end of treatment. Results of the study showed that 86% (516 patients) achieved SVR.

Response rates for patients achieving SVR were similar across the 3 provider types as follows: NPs, 89.3%, PCPs, 86.9%, and specialists, 83.8%. Of the 84 patients who did not achieve SVR, 45 were lost to follow up, 35 had viral relapse, and 4 died. 

The results show that nonspecialist providers can safely and effectively use DAA-based HCV therapy in real-world community health centers. Visit the Annals of Internal Medicine [Exit DisclaimerPDF, 191KB] to read the entire research study.

Importantly, there were high cure rates even in patients with HIV coinfection, cirrhosis, or previous HCV interferon treatment experience. The results of this study suggest that with newer DAA therapy, nonspecialist providers can be rapidly trained to offer a single stop “diagnosis-linkage-treatment” continuum for uncomplicated HCV infection cases and avoid the need for specialist referrals.

“The most effective way to reduce deaths and improve the health of people living with HCV infection is to expedite the diagnosis, care, treatment, and cure of all individuals living with chronic HCV infection,” said Corinna Dan, R.N., M.P.H., Viral Hepatitis Policy Advisor, Office of HIV/AIDS and Infectious Disease Policy. “Expansion of treatment to non-specialist providers can help us do this and is much needed.”

Learn more about the National Viral Hepatitis Action Plan, a strategic framework that highlights the commitment of more than 20 federal partners working together to fight viral hepatitis in partnership with states, counties, cities and hundreds of organizations around the country.