Research Shows HCV Treatment with Non-Specialists Is Safe and Effective

New antiviral treatments have high cure rates; however, millions of people infected with hepatitis C remain unable to access treatment. While cost remains a barrier to treatment for many, a lack of specialist physicians to prescribe treatment and oversee care for the millions with hepatitis C poses a national problem. Presently, many insurers only approve direct-acting antiviral (DAA) treatment when prescribed by HCV specialists, such as hepatologists, gastroenterologists, and infectious disease clinicians.1 There are an estimated 20,000 gastroenterology, hepatology, and infectious disease physicians in the United States. While that may seem like a large number of specialist physicians, it is inadequate to meet the needs of the millions living with HCV in the US.2

Researchers wanted to evaluate if non-specialist providers, such as nurse practitioners (NPs) and primary care physicians (PCPs), can provide effective and safe treatment to people with hepatitis C.1 The clinical trial was conducted at 13 community health centers in Washington, DC. The researchers recruited 600 people with chronic HCV infection who were assigned to receive treatment with Harvoni (ledipasvir and sofosbuvir) from one of three different types of healthcare providers. Of the 600 people in the clinical trial, 150 received treatment from an NP, 160 received treatment from a PCP, and 290 received treatment from a specialist. All providers underwent an identical three-hour training session based on the most up-to-date clinical guidelines.2

What Did the Research Show?

Of the 600 patients in the study, 516 (86%) achieved sustained virologic response (SVR) and were cured of hepatitis C. The majority of patients who did not reach SVR had dropped out of the trial and did not complete the study.

The cure rates were consistent across all three groups.

  • 89.3% of patients treated by NPs were cured
  • 86.8% of patients treated by PCPs were cured
  • 83.8% of patients treated by specialists were cured2

These results show that hepatitis C treatment under non-specialists is safe and effective.

What Does This Mean for People Seeking Treatment?

These findings are important and will hopefully have a positive impact on those seeking treatment. While it was important to demonstrate that cure rates were similar regardless of the treating clinician, it is also important to note that the high cure rates were maintained even in patients with complex medical histories and comorbidities, such as HIV co-infection, cirrhosis, or previous interferon treatment experience. In addition, the research was conducted real-world setting that serves many patients seeking hepatitis C treatment.

Many public and private insurance plans and managed care organizations in the US restrict approval of HCV treatment based on the healthcare provider type. Due to these restrictions, most PCPs and NPs are not able to prescribe hepatitis C treatment. The results of this research show that these restrictions are not supported by evidence and are a barrier to treatment. If these insurance requirements are removed, safe and effective HCV treatment can be accessed by a larger population of patients immediately after a diagnosis, avoiding the wait for referrals.2

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