Lab Matters Spring 2022 - Page 20

INFECTIOUS DISEASES

APHL , CDC Prioritize Hepatitis C Elimination in Meeting , New Publication

By Anne Gaynor , PhD , deputy director , Infectious Diseases
A once incurable and potentially deadly bloodborne pathogen , hepatitis C virus ( HCV ) still causes nearly 1.5 million infections each year and as much as 40 % of the nearly 58 million persons infected worldwide are unaware that they are infected , based on estimates from the World Health Organization . 1 In the United States , rates of hepatitis C tripled between 2011 and 2018 with an estimated 2.4 million Americans living with HCV in 2016 . 2 Beginning in 2014 , a cure became much more realistic when highly effective antivirals for HCV became available .
In 2021 the US Department of Health and Human Services launched “ The Viral Hepatitis National Strategic Plan ; a Roadmap to Elimination ” with major goals focused on preventing infections , ensuring every person knows their status , and every person with viral hepatitis has high-quality healthcare and treatment and lives free from stigma and discrimination . 2 This five-year framework is part of a larger effort to eliminate viral hepatitis as a public health threat by 2030 . 3
As part of the HHS national strategy , the US Centers for Disease Control and Prevention ( CDC ) announced updated universal screening recommendations for HCV and called upon its partnership with APHL to address the goals that focus on preventing infections and ensuring everyone knows their status — both which rely on an appropriate HCV diagnosis . 4 On October 19-20 , 2021 , APHL convened a meeting , “ Identify High-Priority Approaches for Advancing Hepatitis C Elimination in the US ,” to bring together over 75 stakeholders from the US Food and Drug Administration ( FDA ), CDC and the Centers for Medicare & Medicaid Services along with subject matter experts from public health agencies , clinical providers , diagnostic manufacturers and clinical laboratories . The virtual meeting was also livestreamed to approximately 120 additional attendees to ensure broad access .
The current CDC recommendations for laboratory diagnosis of HCV relies on a two-step process , initial testing with an HCV serologic assay and , if positive ,
Hepatitis C virus confirmation of current infection with an HCV RNA test . This two-step process can also cause further bottlenecks due to both tests frequently not being ordered and / or performed at the same time .
By the end of the meeting a handful of key priorities had been identified to be addressed by the various stakeholders in attendance . One of the major focuses of the meeting — and a priority recommendation — was to ensure that the proposed down-classification of HCV diagnostic tests is finalized by FDA . Down-classification is intended to align the current risks associated with an incorrect HCV test result with the current landscape . This would allow diagnostic manufacturers of HCV tests to seek approval through a less burdensome FDA approval process ( 510k ), which is used for most diagnostic methods in the infectious disease field — therefore more familiar to diagnostic companies — instead of the premarket approval application , which is the most stringent review at FDA .
One month after the meeting , on November 19 , 2021 the proposed downclassification became final — hopefully
opening the door for more companies to bring HCV diagnostic tests to market in the US . Not all of the other priorities from the meeting will be as straightforward but we look forward to working with the meeting attendees and partners to improve HCV diagnostics .
APHL will be publishing a draft meeting report in the spring and a final report by June 2022 . The full recorded meeting and slides are available at aphl . org . •
References
1 . World Health Organization . Hepatitis C Factsheet . Available at : https :// www . who . int / news-room / fact-sheets / detail / hepatitis-c
2 . U . S . Department of Health and Human Services . 2020 . Viral Hepatitis National Strategic Plan for the United States : A Roadmap to Elimination ( 2021 – 2025 ). Washington , DC . Available at : https :// www . hhs . gov / sites / default / files / Viral-Hepatitis-National-Strategic- Plan-2021-2025 . pdf
3 . United Nations General Assembly resolution A / RES / 70 / 1 – Transforming our world : the 2030 Agenda for Sustainable Development , see Target 3 . Available at : http :// www . un . org / ga / search / view _ doc . asp ? symbol = A / RES / 70 / 1 & Lang = E
4 . Schillie S , Wester C , Osborne M , Wesolowski L , Ryerson AB . CDC Recommendations for Hepatitis C Screening Among Adults — United States , 2020 . MMWR Recomm Rep 2020 ; 69 ( No . RR-2 ): 1 – 17 . DOI : http :// dx . doi . org / 10.15585 / mmwr . rr6902a1
18 LAB MATTERS Spring 2022
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