2025-00204Notice

Establishing a Road Map for Accelerated Diagnosis and Treatment of HCV Infection in the United States

Published Date: 1/8/2025

Notice

Summary

The CDC is bringing together experts and the public in a virtual meeting to speed up how we find and treat hepatitis C in the U.S. They’re focusing on quick, same-day testing and new viral-first methods to get people treated faster. This effort kicks off in February 2025 and aims to guide future testing strategies without spending new money right now.

Analyzed Economic Effects

4 provisions identified: 4 benefits, 0 costs, 0 mixed.

CDC screening recommendation for all adults

The CDC recommends hepatitis C screening for all adults at least once, for all pregnant persons during every pregnancy, and for people with ongoing risk (periodic testing). These are current CDC screening recommendations cited in the notice.

FDA-authorized CLIA-waived near point-of-care HCV RNA test

In June 2024, the FDA authorized a CLIA-waived near point-of-care HCV RNA test. The notice says virologic tests (RT-PCR and HCV core antigen) have become faster and more accessible in a variety of care settings, including closer to the point-of-care.

Viral-first testing affirmed for recent exposure

In January 2024, CDC affirmed existing viral-first HCV testing recommendations for people with recent HCV exposure. Viral-first means testing for viral markers (like HCV RNA) as the first test to identify current infection sooner.

CDC updating HCV testing guidance for general population

CDC began the process in January 2024 to update HCV testing guidance for clinicians and laboratorians to evaluate testing strategies for the general population that include viral markers in the first testing step ("viral-first").

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Key Dates

Published Date
Effective Date
1/8/2025
2/11/2025

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