Hepatitis C: 5 Things to Know

Nancy S. Reau, MD


July 05, 2019

4. Access to therapy is still limited but improving.

Access to therapy remains a limitation for many patients. This limited access was previously justified by the inability to afford treatment for all patients with HCV, so restrictions were implemented on the basis of disease severity, defined primarily by advanced fibrosis, patient adherence or behaviors (eg, active drug use), and provider type, meaning that a patient might need to see a specialist even if the primary care physician felt comfortable managing the therapy. Rules can change rapidly, however. Many states have now started to loosen restrictions; see how your state measures. Competitive drug development has also significantly decreased cost, from $90,000 per course to about $25,000 per course.

Despite these measures, there is still concern that overall cost will be unaffordable as more individuals have access to therapy, which has led to an innovative pricing model. In 2015, Australia negotiated the "Netflix model" based on the video streaming company that allows unlimited access to content for a monthly subscription. Under this model, Australia agreed to pay $1 billion AUD in exchange for unlimited access to direct-acting antiviral therapy for 5 years.[11] Modeling suggests that this could save the country $6.42 billion AUD over traditional per-pack pricing. Louisiana became the first US state to also adopt this novel plan to broaden access, contracting with the Gilead Sciences subsidiary Asegua Therapeutics in March 2019.[12] Washington State followed suit, selecting AbbVie as its provider.[13]

5. Elimination of HCV is possible, but the United States has a long way to go.

Given that HCV is curable, eliminating it from the world population is attainable. Analysis by the World Health Organization (WHO) found that with effective prevention and treatment, hepatitis C could be eliminated as a public health threat by 2030.[14]

The WHO defines elimination as:

  • 90% reduction in incidence

  • 65% reduction in liver-related deaths

  • 90% of infections diagnosed

  • 80% of infections treated

Effective treatment is not enough to eliminate HCV, however. The HCV care cascade is outlined by effective screening, disease confirmation, staging, linkage, and ultimately treatment. Each step in the cascade must work to eliminate HCV. Unfortunately, breakdown in each step of the cascade, especially access to HCV therapy, suggests that the target to elimination is well beyond 2050 in the United States.[15]

Information from two large de-identified lab-based datasets (acquired between 2013 and 2016) was used to analyze the US HCV Care Cascade.[16] Of the more than 17 million individuals tested, 5.7% were positive for HCV-Ab. Of those, only 54.1% had HCV RNA testing to confirm active infection; 46% were unaware of their HCV status despite screening positive. This step of confirmatory testing can be eliminated with reflex testing that automatically tests for HCV RNA in positive HCV-Ab samples. Unfortunately, the dataset showed that even in those diagnosed with HCV (ie, those who were HCV RNA positive), only 53% had genotype testing and 43% had liver function assessed. Also, of those diagnosed, 90% did not receive HCV treatment.

The United States is not alone. Recent analysis found that only seven of 45 high-income countries (Spain, Iceland, Australia, France, South Korea, Switzerland, and the United Kingdom) have made necessary changes to meet the WHO challenge.[15]

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