Hepatitis C Virus (HCV) and Our Industry: FDA’s Upcoming Guidance
Thanks for joining as we discuss the Food and Drug Administration’s (FDA) thought for our next topic on hepatitis C virus (HCV), “Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)”. This upcoming guidance is still in its comment period and once implemented, will supersede the guidance, “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry,” dated August 2007, for specific recommendations for HCT/P donor testing and screening for risk associated with HCV infection.
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus and a major global public health problem. The virus can cause both acute and chronic hepatitis, ranging in severity from a mild illness to a serious, lifelong illness including liver cirrhosis and cancer. The hepatitis C virus is a bloodborne virus and most infection occur through exposure to blood from unsafe injection practices, unsafe health care, unscreened blood transfusions, injection drug use and sexual practices that lead to exposure to blood. Direct-acting antiviral medicines (DAAs) can cure more than 95% of persons with hepatitis C infection, but access to diagnosis and treatment is low. There is currently no effective vaccine against hepatitis C 1 .
The FDA identified HCV as a relevant communicable disease agent or disease (RCDAD) and requires donor screening and testing for specific risk factors and conditions associated with this infection as it is transmissible by HCT/Ps, organs, and transfusion of blood products.
FDA revised recommendations for:
1. Donor screening that includes reducing certain time-based risk factors and conditions, and
2. Assessing every HCT/P donor for HCV risk using the same individual risk-based questions regardless of sex or gender.
Establishments are required to review relevant medical records and ask questions about the donor’s medical history and relevant conditions and behavioral risks including risk factors for RCDADs.
Risk factors for HCV include:
1. Persons who have ever had a positive or reactive screening test for HCV
2. Persons who have engaged in non-prescription injection drug use in the preceding 3 months, including intravenous, intramuscular, or subcutaneous injections
3. Persons who have had sex (unless specified as “anal sex,” the term “sex” or “sexual contact” refers to vaginal, anal, or oral sex, regardless of whether a condom or other protection is used) in exchange for money or drugs or other payment in the preceding 3 months
4. Persons who have had sexual contact in the preceding 3 months with any individual who has ever had a positive test for HCV infection
5. Persons who have had sexual contact in the preceding 3 months with any individual who has exchanged sex for money, drugs or other payment. If there is any uncertainty about when their sexual partner exchanged sex for money, drugs or other payment, the person is ineligible for 3 months
6. Persons who have had sexual contact in the preceding 3 months with any individual who has engaged in non-prescription injection drug use. If there is any uncertainty about when their sexual partner engaged in non-prescription injection drug use, the person is ineligible for 3 months
7. Persons who have had a new sexual partner (the following examples would be considered having sex with a new partner: having sex with someone for the first time; or having had sex with someone in a relationship that ended in the past and having sex again with that person) in the preceding 3 months and have had anal sex in the preceding three months
8. Persons who have had more than one sexual partner in the preceding 3 months and have had anal sex in the preceding three months
9. Persons who have been exposed in the preceding 3 months to known or suspected HCV-infected blood through percutaneous inoculation (e.g., needle stick) or through contact with an open wound, non-intact skin, or mucous membrane
10. Persons who have been in lock up, jail, prison, or a juvenile correctional facility for more than 72 consecutive hours in the preceding 3 months
11. Persons who have lived with (resided in the same dwelling) another person who has HCV infection in the preceding 3 months
12. Persons who have undergone tattooing, ear piercing or body piercing in the preceding 3 months, in which sterile procedures were not used, e.g., contaminated instruments and/or ink were used, or shared instruments that had not been sterilized between uses were used. A person may be eligible, for example, if a tattoo was applied by a state regulated entity with sterile needles and non-reused ink, or if ear or body piercing was done using single-use equipment
13. Children 1 month of age or younger who were born to a mother with, or at risk for, an HCV infection; see risk factors above
Clinical evidence of HCV Infection for ineligible donors with relevant medical record review may include:
1. A prior positive or reactive screening test for HCV;
2. Unexplained jaundice;
3. Unexplained hepatomegaly;
4. Generalized lymphadenopathy; and/or
5. Unexplained generalized rash or fever.
Laboratory data records that may assist in determining eligibility where there is an inconclusive history of hepatitis infection (note: these test results should not be used alone to determine donor eligibility):
1. alanine aminotransferase (ALT);
2. aspartate aminotransferase (AST);
3. bilirubin; or
4. prothrombin time.
Indications of high-risk behavior associated with HCV that would increase the donor’s RCDAD risk or physical evidence of HCV are:
1. Physical evidence for risk of sexually transmitted diseases and infections, such as perianal lesions, genital ulcerative disease, herpes simplex, or chancroid (when making a donor eligibility determination, establishments should consider these findings in light of other information obtained about the donor)
2. Physical evidence of nonmedical percutaneous drug use such as needle tracks; the examination should include examination of tattoos, which might be covering needle tracks
3. Physical evidence of recent tattooing, ear piercing, or body piercing. Persons who have undergone tattooing, ear piercing, or body piercing in the preceding 3 months, in which sterile procedures were not used (e.g., contaminated instruments and or/ink were used), or instruments that had not been sterilized between uses were used. A person may be eligible, for example, if a tattoo was applied by a state regulated entity with sterile needles and non-reused ink, or if ear or body piercing was done using single-use equipment
4. Unexplained jaundice, hepatomegaly, or icterus. (Note: Hepatomegaly may not be apparent in a physical assessment unless an autopsy is performed)
5. Generalized lymphadenopathy
6. Unexplained generalized rash or fever
Current Donor Screening Tests approved by the FDA:
1. FDA-licensed donor screening test for antibody to hepatitis C virus (anti-HCV); and
2. FDA-licensed donor screening Nucleic Acid Test for HCV (HCV NAT); or a combination or multiplex NAT that includes HCV.
Any HCT/P donor whose specimen tests negative (or non-reactive) for both assays (i.e., anti-HCV and HCV NAT) is considered to be negative (or non-reactive) when making a donor eligibility determination. Note that a negative (or non-reactive) test does not necessarily mean that a donor is eligible; donor screening also applies as described above.
Any HCT/P donor whose specimen tests positive (or reactive) using either of the assays (i.e., anti-HCV or HCV NAT) is considered ineligible (21 CFR 1271.80(d)(1)).
Reference the FDA licensed donor screening tests here:
The American Association of Tissue Banks (AATB) provided feedback to the FDA February 6, 2025, for the release of this proposed guidance, read more about it here:
https://www.aatb.org/government-advocacy-correspondences
Reference the FDA guidance here:
Keep following us for more updates!
References:
1 https://www.who.int/news-room/fact-sheets/detail/hepatitis-c