Notice2025-15859
Establishing a Road Map for Accelerated Diagnosis and Treatment of HCV Infection in the United States
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Published
August 20, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC) announces a two-day convening hosted and facilitated by the Association of Public Health Laboratories (APHL) to discuss hepatitis C diagnostics. Leaders from public health, laboratory, medical, academic, and industry sectors will have the opportunity to provide individual input, without building a consensus, on accelerating the diagnosis of current hepatitis C virus (HCV) infection. Members of the public with interest and expertise in diagnosing HCV infection are also invited to provide individual input. Specifically, the convening will focus on how to leverage the following hepatitis C diagnostic methods: same-day diagnosis and treatment, and viral-first testing.
Full Text
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<title>Federal Register, Volume 90 Issue 159 (Wednesday, August 20, 2025)</title>
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[Federal Register Volume 90, Number 159 (Wednesday, August 20, 2025)]
[Notices]
[Pages 40605-40606]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15859]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2025-0321]
Establishing a Road Map for Accelerated Diagnosis and Treatment
of HCV Infection in the United States
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Centers for Disease Control and Prevention (CDC) announces
a two-day convening hosted and facilitated by the Association of Public
Health Laboratories (APHL) to discuss hepatitis C diagnostics. Leaders
from public health, laboratory, medical, academic, and industry sectors
will have the opportunity to provide individual input, without building
a consensus, on accelerating the diagnosis of current hepatitis C virus
(HCV) infection. Members of the public with interest and expertise in
diagnosing HCV infection are also invited to provide individual input.
Specifically, the convening will focus on how to leverage the following
hepatitis C diagnostic methods: same-day diagnosis and treatment, and
viral-first testing.
DATES: Written comments must be received on or before September 24,
2025.
Times: September 16, 2025, 2:00-5:30 p.m. EDT and September 17,
2025, 1:00-4:45 p.m. EDT. To register for this virtual meeting on the
public line (listen-only access), please use the following link:
<a href="https://webster.eventsair.com/hepatitis-2025-meeting/hcvattendee/Site/Register">https://webster.eventsair.com/hepatitis-2025-meeting/hcvattendee/Site/Register</a>.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0321 by either of the methods listed below. Do not submit comments by
email. CDC does not accept comments by email.
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Follow the instructions for submitting comments.
<bullet> Mail: Office of Policy and Communications, Division of
Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD,
and TB Prevention, Centers for Disease Control and Prevention, 1600
Clifton Road, MS US12-3, Atlanta, GA 30329-4018.
Instructions: All submissions received must include the agency name
and docket number. All relevant comments received will be posted
without change to <a href="http://regulations.gov">http://regulations.gov</a>, including any personal
information provided. For access to the docket to read background
documents or comments received, go to <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: D'Angela T. Green, Office of Policy
and Communications, Division of Viral Hepatitis, National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease
Control and Prevention, 1600 Clifton Road, MS US12-3, Atlanta, GA
30329-4018, phone: 1 (404) 718-8539, email: <a href="/cdn-cgi/l/email-protection#b6d2c0dec6d9dadfd5cff6d5d2d598d1d9c0"><span class="__cf_email__" data-cfemail="0561736d756a696c667c456661662b626a73">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: CDC announces a convening to discuss
hepatitis C diagnostics. Interested parties are invited to provide
public comment on <a href="http://regulations.gov">regulations.gov</a> in docket CDC-2025-0321 on or before
September 24, 2025. The goal of the convening will be for each person
to give their individual input, and not to build consensus. No
discussions, recommendations, or advice to CDC will occur or be
provided at the meeting. Day 1 will focus on the utility of point-of-
care (POC) testing for accelerating same-day HCV diagnosis and rapid
treatment initiation. Day 2 will focus on the utility of viral-first
testing strategies for accelerating HCV diagnosis and treatment
initiation in the United States. Following the meeting, APHL will
prepare a meeting report summarizing the discussion and public comment
received through <a href="http://regulations.gov">regulations.gov</a>, developed and documented as
individual input to ensure thorough and complete input from partners.
CDC and APHL will disseminate the APHL-prepared report as a reference
for partners and industry to follow in developing and implementing
future hepatitis C testing strategies. The final report will be added
to docket CDC-2025-0321 once it is available.
Background
More than 2.4 million adults in the United States are estimated to
have hepatitis C virus (HCV) infection [Eric H, Hepatology 2024]. New
infections continue to increase, primarily in association with
injection drug use; nearly 69,000 cases of acute hepatitis C are
estimated to have occurred in 2023 [CDC 2023 VH Surv Rpt]. More than
half of new infections progress to chronic infection [Seo S, Clin
Gastro Hepatol 2020]. Without treatment, HCV infection can lead to
advanced liver disease, liver cancer, and death [Liang TF, Ann Intern
Med 2000]. Since 2013, safe and effective treatment has been available
that cures more than 95% of all treated persons, prevents future health
complications, stops further
[[Page 40606]]
transmission, and allows for the possibility of hepatitis C elimination
[Falade-Nwulia O, Ann Intern Med 2017].
Testing is the first step to accessing life-saving treatment;
however, about one-third of people with hepatitis C in the United
States are unaware of their infection [Lewis KC, CID 2024]. The Centers
for Disease Control and Prevention (CDC) recommends hepatitis C
screening for all adults at least once, all pregnant women during every
pregnancy, and all persons with risk for HCV infection, including
periodic testing if risk persists [Schillie S, MMWR Recomm Rep 2020].
Current testing guidance for clinicians and laboratorians begins with a
hepatitis C antibody (anti-HCV) test followed, when reactive, by a
nucleic acid test to detect HCV RNA to diagnose current infection [CDC
MMWR 2013]. Updated operational guidance was provided to ensure
completion of the two-step approach using specimens collected during a
single patient encounter. (Cartwright EJ, MMWR 2023)
A limitation of the antibody-first hepatitis C testing approach is
that it takes an average of 7 to 8 weeks after HCV infection to develop
a reactive HCV antibody (Abdel-Hamid M, Clin Micro 2002). Therefore,
the current testing sequence fails to diagnose HCV infection in the
window-phase/early acute phase, within the initial months following
infection, and among immunocompromised people who may have delayed
seroconversion. Fortunately, advancements in the diagnostic and
regulatory landscape have created an opportunity to improve hepatitis C
testing. Currently, there are two tests for viral markers that identify
current HCV infection: (1) real-time (RT) polymerase chain reaction
(PCR) testing of HCV ribonucleic acid (RNA) detects virus within 1 to 2
weeks of infection (Gowda C, Clin Infect Dis 2020); and (2) HCV core
antigen (HCVcAg) testing, currently approved outside of the United
States, that uses an immunoassay to detect HCV core antigen within 2 to
3 weeks of infection (Sepulveda-Crespo D, Rev Med Virol 2023). Such
virologic tests have become faster to perform and more accessible in a
variety of care settings including closer to the point-of-care.
With CDC support, the Association of Public Health Laboratories
(APHL) held a 2-day convening of key stakeholders and subject matter
experts in October 2021 to identify high-priority diagnostic tools
needed to advance diagnosis of current HCV infection and linkage to
treatment in a range of clinical and nonclinical settings. The
published meeting report called for the U.S. Food and Drug
Administration (FDA) to reclassify HCV diagnostic tests from class III
to class II, supported the availability of an FDA-cleared rapid CLIA-
waived point-of-care (POC) HCV viral detection test, and encouraged CDC
to review and update recommendations for HCV testing to identify
current HCV infection, including testing sequences that detect HCV
viral markers in the first step. (<a href="https://www.aphl.org/aboutAPHL/publications/Documents/ID-HCV-2021-Meeting-Report.pdf">https://www.aphl.org/aboutAPHL/publications/Documents/ID-HCV-2021-Meeting-Report.pdf</a>).
Subsequent to the APHL-led meeting:
In November 2021, the FDA reclassified hepatitis C diagnostic tests
from class III devices to class II devices with special controls
(510k). This action provided a new, lower-barrier opportunity for
manufacturers to introduce new hepatitis C diagnostic tools for FDA
review, including tests that were available at that time outside of the
United States, such as a nucleic acid test for HCV RNA detection in a
point-of-care format and an assay for HCVcAg.
In January 2024, CDC affirmed existing viral-first testing
recommendations among people with recent HCV exposure ( ).
In January 2024, CDC began the process of updating HCV testing
guidance for clinicians and laboratorians, including evaluating testing
strategies for the general population that include tests for viral
markers in the first testing step (e.g., ``viral-first'').
In June 2024, the FDA authorized an HCV RNA CLIA-waived near point-
of-care test for the diagnosis of current HCV infection.
Public Participation
Public engagement will entail listen-only observation of
information shared on day 1 and day 2. If members of the public have
input on the questions asked during the meeting, those public comments
can be submitted through <a href="http://regulations.gov">regulations.gov</a> using docket CDC-2025-0321 on
or before September 24, 2025, and will be included in the final meeting
report.
Please note that comments received, including attachments and other
supporting materials, are part of the public record and are subject to
public disclosure. Comments will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Therefore, do not include any information in your
comment or supporting materials that you consider confidential or
inappropriate for public disclosure. If you include your name, contact
information, or other information that identifies you in the body of
your comments, that information will be on public display. CDC will
review all submissions and may choose to redact, or withhold,
submissions containing private or proprietary information such as
Social Security numbers, medical information, inappropriate language,
or duplicate/near duplicate examples of a mass-mail campaign. Do not
submit comments by email. CDC does not accept comment by email.
Noah Aleshire,
Chief Regulatory Officer, Centers for Disease Control and Prevention.
[FR Doc. 2025-15859 Filed 8-19-25; 8:45 am]
BILLING CODE 4163-18-P
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